Growth in adolescent hemodialysis patients: Data from the Centers for Medicare & Medicaid Services ESRD Clinical Performance Measures Project

The Centers for Medicare & Medicaid Services' (CMS) end-stage renal disease (ESRD) Clinical Performance Measures (CPM) Project has collected data on all adolescent hemodialysis patients since 2000. Thus, by 2002 data were available on all adolescents on hemodialysis in the USA for 3 consecutive years. Possible associations between clinical parameters and linear growth in this cohort were evaluated. Ninety-four adolescents were on hemodialysis for the 3 study years. The mean height standard deviation score (ht SDS) fell from -1.97 to -2.36 over the 3 study years. Compared with patients with ht SDS > or =-1.88, patients with ht SDS <-1.88 in the 2002 study year (n =53) were more likely to be male (66% vs 44%, p <0.05), on dialysis longer (6.9+/-4.5 years vs 4.1+/-2.3 years, p <0.001), and had lower height SDS in the 2000 study year (-2.90+/-1.31 vs -0.772+/-1.10, p <0.001). Patients with a ht SDS <-1.88 had a lower mean hemoglobin (11.4+/-1.6 g/dl vs 12.0+/-1.1 g/dl, p <0.05), but there were no differences in other clinical parameters. Among patients with ht SDS <-1.88, 38.8% (n =20) were prescribed recombinant human growth hormone (rhGH) in the 2002 study year. There were no differences in demographic or clinical parameters between rhGH treated and untreated patients. Many adolescents who remain on hemodialysis have poor linear growth. Further evaluation is needed to delineate contributory factors and the possible underutilization of rhGH.     

Disparate outcomes in pediatric peritoneal dialysis patients by gender/race in the End-Stage Renal Disease Clinical Performance Measures project

Associations between achievement of adult Kidney Disease Outcomes Quality Initiative (KDOQI) targets for hemoglobin, adequacy and albumin, and race and gender were determined for pediatric peritoneal dialysis patients from the End-Stage Renal Disease (ESRD) Clinical Performance Measures (CPM) project for the period October 2004-March 2005. Fifty-six percent (427/761) of patients were male. Sixty-six percent (500/761) of patients were White. There were no differences in achievement of targets for adults by gender, and no differences in adequacy parameters by race. Blacks had lower mean hemoglobin levels than did Whites (11.1 +/- 1.6 g/dl vs 11.8 +/- 1.4 g/dl, P < 0.0001). Blacks were more likely to have mean hemoglobin levels < 10 g/dl (24% vs 11%, P < 0.0001) and less likely to achieve mean hemoglobin > 11 g/dl (56% vs 72%, P < 0.0001). Whites were more likely to achieve mean serum albumin levels > 4.0/3.7 g/dl [bromocresol green/bromocresol purple (BCG/BCP)] than Blacks were (35% vs 26%, P = 0.0376). In multivariate logistic regression models, White race was associated with mean hemoglobin levels > 11 g/dl [adjusted odds ratio (adj OR) 2.7, 95% confidence interval (CI) 1.7, 4.3] and mean serum albumin > 4.0/3.7 g/dl (BCG/BCP) (adj OR 1.9, 95% CI 1.3, 2.9]. Further study is needed of factors associated with anemia on peritoneal dialysis and barriers to its correction.     

Comparison of the effects of enalapril and losartan on posttransplantation erythrocytosis in renal transplant recipients: prospective randomized study

BACKGROUND: The aim of this prospective randomized study was to compare the safety and efficacy of enalapril (E) and losartan (L) in the treatment of posttransplantation erythrocytosis and the effect of the ACE genotype on response to therapy. METHODS: Twenty-seven (24 male and 3 female, mean age 34+/-8 years) renal transplant recipients with erythrocytosis were treated either with E (15 patients) (10 mg/day) or L (12 patients) (50 mg/day) for 8 weeks. RESULTS: The hemoglobin levels were significantly decreased in the L (17.1+/-0.7 to 15.9+/-1.3 g/dl, P=0.01) and E groups (17.4+/-1.1 to 14.9+/-2.2 g/dl, P=0.001). Among the responders who discontinued treatment, there was a trend for longer time to relapse in the L group (7.38+/-3.75 months; 95% confidence interval: 0.03-14.7) compared with the E group (2.75+/-0.70 (95% confidence interval: 1.37-4.13) (P=0.11). Decrease in hemoglobin was more prominent with E compared with L (-3.26+/-0.65 vs. -1.70+/-0.39 g/dl, P=0.05). Decrease in hemoglobin levels between DD and non-DD genotype groups was similar (-2.0+/-1.5 vs. -1.7+/-2.3 g/dl, P=0.69). CONCLUSIONS: Enalapril caused a greater decrease but faster relapse in hemoglobin levels compared with losartan in patients with posttransplantation erythrocytosis. The DD type polymorphism had no effect on response.     

Intravenous ascorbic acid in hemodialysis patients with functional iron deficiency: a clinical trial

BACKGROUND: Hemodialysis (HD) patients with functional iron deficiency (FID) often develop resistance to recombinant human erythropoietin (rHuEpo). In these patients, iron therapy may be a hazard, leading to iron overload and consequently to hemosiderosis. Recent studies suggest that intravenous ascorbic acid (IVAA) may circumvent rHuEpo resistance. The aim of our study was to show the effects of IVAA on FID and whether this results in a better correction of anemia in HD patients with stable hemoglobin (Hb) concentration and FID. METHODS: Twenty-seven HD patients with serum ferritin >300 microg/l, transferrin saturation (TS) <20% and hemoglobin (Hb) <10 g/dL were selected andrandomly divided into two groups to enter a cross-over trial with IVAA. In group I IV vitamin C 500 mg was administered three times a week for three months and discontinued in the next three months of the study. Vitamin C was not given the first three months in group II (control group, first three months of the study), who then received 500 mg IV three times a week for the next three months. RESULTS: Hb and TS% significantly increased (baselines vs 3 months, Hb 9.2 +/- 0.2 vs 10.0 +/- 0.3 g/dL, TS% 17.5 +/- 0.6 vs 25.7 +/- 1.7, respectively p < 0.01 and p <0.001) in group I after three months; ferritin fell significantly from 572 +/- 40 to 398 +/- 55 microg/L (p<0.004). Ten patients completed the study: mean Hb and TS% fell significantly (3 months vs final, Hb 9.9 +/- 0.3 vs 8.9 +/- 0.2 g/dL, TS% 25.1 +/- 1.2 vs 19.1 +/- 1.1, respectively p < 0.01 and p <0.001), while mean ferritin did not change. Mean Hb, ferritin and TS% remained unchanged in group II after three months. Hb and TS% mean values rose significantly (3 months vs final, Hb 9.0 +/- 0.2 vs 9.9 +/- 0.2 g/dl, TS% 18.4 +/- 1.0 vs 27.0 +/- 1.0, respectively p < 0.005 and p <0.001), and ferritin markedly decreased from 450 +/- 50 to 206 +/- 24 microg/L (p < 0.001) at the end of the study. The rHuEpo dose was kept unchanged throughout the study. Differences were analyzed after three months. Mean Hb rose (0.8 +/- 0.2 g/dL) in group I but dropped (-0.1 +/- 0.1 g/dL) (p< 0.009) in group II. Ferritin dropped in both groups (group I vs group II, -173 + /-48 vs - 33 +/- 21 microg/L) (p < 0.01) while TS% increased (group I vs group II, 8.2 +/- 1.5 vs 0.4 +/- 0.7) (p < 0.001). CONCLUSION: IVAA may partially correct FID and consequently help rHuEpo hyporesponsive anemia.     

Inflammation and pruritus in haemodialysis patients.

BACKGROUND: Pruritus is a common symptom among patients on haemodialysis (HD). We studied 68 HD patients to assess the role of iron deficiency, anaemia, inflammation and other common serum and dialysis parameters in pruritus. METHODS: The patients were questioned about the occurrence of pruritus at home, quantified according to frequency ('never', 'occasionally' and 'every day') and intensity ('absent', 'moderate' and 'severe'). The blood and serum variables considered were: haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, hypochromic red blood cells (RBC), hyperchromic RBC, microcytic RBC, macrocytic RBC, reticulocytes, iron, ferritin, transferrin, transferrin saturation, C-reactive protein (CRP), urea, creatinine, calcium, phosphorus, albumin, total protein and glucose. We also analysed Kt/V, age and time on HD treatment. Patients were divided into 3 groups according to the frequency or intensity of their pruritus, and we analysed and compared the variables between the 3 groups. RESULTS: Half (50%) of the patients reported never having pruritus, 32.4% occasionally and 17.6% every day. Pruritus was moderate in 41.2% of them and severe in 8.8%. None of the parameters considered revealed any statistically relevant differences between the three pruritus frequency groups, except for mean serum transferrin level (mg/dl) ('never'=268+/-64 vs 'occasionally'=244+/-40 vs 'every day'=217+/-56, P<0.05). As for the intensity of the symptom, mean serum transferrin (268+/-64 vs 247+/-39 vs 174+/-31, P<0.001) and median ferritin levels (mg/dl) (83 (11-420) vs 98 (11-1121) vs 293 (111-471), P<0.05) showed statistically significant differences between the 3 groups, as did albumin levels (g/dl) (4.3+/-0.4 vs 4.2+/-0.4 vs 3.7+/-0.4, P<0.05). Median CRP values (mg/dl) tended to be higher in patients with more frequent (0.4 (0.3-5.5) vs 0.7 (0.3-11.4) vs 0.9 (0.3-13.5)) and more severe pruritus (0.4 (0.3-5.5) vs 0.7 (0.3-4.0) vs 2.1 (0.3-13.5)), but those differences were not statistically significant. CONCLUSIONS: Iron deficiency and anaemia seem to play no part in HD-related pruritus, whereas lower serum transferrin and albumin levels and higher ferritin values are consistent with the possible role of inflammation in the development and severity of pruritus.     

Circulating levels of ICAM-1, VCAM-1, and MCP-1 are increased in haemodialysis patients: association with inflammation, dyslipidaemia, and vascular events.

BACKGROUND: Increased levels of circulating adhesion molecules and chemokines have been reported in haemodialysis (HD) patients but the influence of the HD membranes on their secretion, as well as their pathophysiological implications, remains largely unknown. METHODS: Circulating levels of intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), and monocyte chemoattractant protein-1 (MCP-1) were measured by immunosorbent assay (ELISA) in 81 HD patients (45 male, mean age 57+/-13 years) and 35 normal subjects. All patients had been stabilized on renal replacement therapy for >3 months and were free of active infection. Thirty-three patients (40.7%) were routinely dialysed with modified cellulose membranes and 48 patients (59.3%) were dialysed with polysulfone membranes. Blood samples were taken directly from the arteriovenous fistula immediately before and at the end of a routine HD session. RESULTS: Pre-dialysis levels were significantly elevated in HD patients compared with controls (ICAM-1 515+/-177 vs 238+/-664 ng/ml, P<0.0001; VCAM-1 2107+/-648 vs 1012+/-115 ng/ml, P<0.0001; MCP-1 427+/-148 vs 125+/-42 pg/ml, P<0.0001). The HD session resulted in a significant increase in the levels of all three molecules measured (515+/-177 vs 679+/-187 ng/ml, P<0.0001; 2107+/-648 vs 2662+/-800 ng/ml, P<0.0001; 427+/-148 vs 567+/-153 pg/ml, P<0.0001, respectively). There was no difference in pre- or post-dialysis levels of the above molecules between patients routinely dialysed with either modified cellulose or polysulfone membranes. MCP-1 levels had a positive correlation with ICAM-1 levels (r=0.41, P<0.0005). VCAM-1 levels had a negative correlation with HDL levels (r=-0.30, P<0.01) and were significantly elevated in patients with HDL <35 mg/dl compared with patients with HDL > or = 35 mg/dl (2300+/-606 vs 1890+/-633 ng/ml, P<0.005). Log-transformed exact C-reactive protein (CRP) values were significantly correlated with ICAM-1 and VCAM-1 levels (r=0.41, P<0.005 and r=0.43, P<0.005, respectively). In addition, compared with patients with normal CRP values, patients with elevated CRP had significantly increased levels of ICAM-1 (466+/-166 vs 580+/-172 ng/ml, P<0.005). Patients with cardiovascular, cerebrovascular, or peripheral vascular diseases had significantly increased serum CRP and ICAM-1 levels compared with patients with no evidence of vascular disease (19.2+/-12.9 vs 7.9+/-11.8 mg/l, P<0.001 and 608+/-189 vs 474+/-155 ng/ml, P<0.005 respectively). CONCLUSIONS: Serum levels of ICAM-1, VCAM-1, and MCP-1 are increased in HD patients and probably result from either inadequate clearance or enhanced synthesis and release. HD session resulted in a significant increase of the above molecule levels but the exact mechanism(s) responsible for these alterations are yet to be fully elucidated. Increased levels of adhesion molecules are associated with inflammation, dyslipidaemia, and cardiovascular events. However, the potential link between these processes and its clinical significance warrants further investigation.     

Use of perflubron emulsion to decrease allogeneic blood transfusion in high-blood-loss non-cardiac surgery: results of a European phase 3 study

BACKGROUND: This single-blind randomized study in general surgery evaluated the efficacy of perflubron emulsion (PFC) as an artificial oxygen carrier being used to augment preoperative acute normovolemic hemodilution to reduce and avoid transfusion of both allogeneic erythrocytes and erythrocytes from preoperative autologous donation compared with standard of care. METHODS: Subjects (N = 492) with hemoglobin concentrations of 12-15 g/dl undergoing noncardiac surgical procedures with 20 ml/kg or greater expected blood loss were randomized into two groups. Control patients were transfused intraoperatively at a hemoglobin concentration less than 8.0 +/- 0.5 g/dl or at protocol-defined, physiologic triggers. PFC-treated patients first underwent acute normovolemic hemodilution to hemoglobin of 8.0 +/- 0.5 g/dl, followed by dosing with perflubron emulsion (1.8 g/kg). When hemoglobin reached less than 6.5 +/- 0.5 g/dl, an additional 0.9-g/kg dose was given. PFC patients were transfused at hemoglobin less than 5.5 +/- 0.5 g/dl or at predefined physiologic triggers. After surgery, hemoglobin was maintained at 8.5 +/- 0.5 g/dl or greater in all patients until discharge. Efficacy endpoints included the number of allogeneic and preoperative autologous donation units transfused and the percentage of subjects avoiding transfusion. RESULTS: Both groups had similar hemoglobin concentrations at screening (13.5 +/- 1.0 g/dl) and at discharge: 10.8 +/- 1.2 g/dl (PFC) and 11.1 +/- 1.3 g/dl (control). At 24 h, more patients in the PFC group avoided allogeneic and preoperative autologous donation erythrocyte transfusions (53% vs. 43%, < 0.05), and fewer erythrocytes were transfused (1.5 +/- 4.8 vs. 2.1 +/- 3.9 units; median, 0 vs. 1 unit; P = 0.013). By day of discharge, these differences were not significant in the intent-to-treat population, but overall there were less allogeneic and preoperative autologous donation erythrocyte transfusions in the PFC group (696 vs. 846 units). In the protocol-defined target population (n = 330 subjects with blood loss > or = 20 ml/kg), significantly greater avoidance of any erythrocyte transfusion was maintained through day of hospital discharge (26% vs. 16% in the PFC and control groups, respectively; P < 0.05), and there was also a significant reduction in the number of erythrocyte units transfused (3.4 +/- 2.9 vs. 4.9 +/- 2.4 units; median 2 vs. 4 units; P < 0.001). Adverse events rates were similar in the PFC (86%) and control (81%) groups; however, more serious adverse events were reported in the PFC group (32%) than in controls (21%; P < 0.05). Overall mortality was 3%, and the difference between groups (PFC, 4% vs. controls, 2%) was not statistically significant. CONCLUSIONS: Augmented acute normovolemic hemodilution with PFC reduces transfusion needs in patients undergoing noncardiac surgical procedures with blood loss 20 ml/kg or greater.     

Effects of optimized heart failure therapy and anemia correction with epoetin beta on left ventricular mass in hemodialysis patients

BACKGROUND: In chronic hemodialysis (HD) patients, the presence and degree of left ventricular hypertrophy (LVH) correlates with mortality. Previous studies have shown that interventions, such as anemia correction or treatment of hypertension and/or chronic heart failure (CHF), can result in moderate regression of LVH. The primary objective of our study was to investigate the effects of a multi-interventional treatment strategy on LVH in HD patients. METHODS AND RESULTS: In a series of 202 consecutive HD patients, we combined optimized CHF therapy, including beta-blockers (BB), ACE inhibitors and angiotensin receptor blockers (ARBs), to target doses with full anemia correction by epoetin beta (hemoglobin (Hb) target males 14.5 g/dl, females 13.5 g/dl). Serial echocardiograms were recorded every 3-6 months. Mean follow-up was 3.4 +/- 1.2 years. Mean Hb at baseline was 11.4 +/- 1.4 vs. 14.6 +/- 1.6 g/dl (p < 0.001) at study end. There was a significant reduction in left ventricular mass index (LVMI, 159 +/- 65 vs. 132 +/- 46 g/m2 (p < 0.001)), an improvement in left ventricular ejection fraction (LVEF, 60 +/- 15 vs. 66 +/- 12% (p < 0.01)) and in NYHA class (2.8 +/- 0.76 vs. 1.96 +/- 0.76 (p < 0.01)) from baseline to follow-up in the overall study population. In a subgroup of 70 patients, LVMI returned to normal (169 +/- 33 vs. 114 +/- 14 g/m2 (p < 0.001)) after 1.4 +/- 1 years. CONCLUSIONS: Our study shows that optimized CHF therapy, in combination with anemia correction to normal Hb targets, results in a significant reduction of LVH, an increase in LVEF and an improvement in NYHA class. Moreover, in contrast to previous studies, our data also demonstrate that complete regression and prevention of LVH in HD patients is possible.     

Staff-assisted nursing home haemodialysis: patient characteristics and outcomes.

BACKGROUND: The number of elderly patients undergoing chronic haemodialysis (HD) in the nursing home (NH) setting is growing; however, little published data exists on this group of patients. METHODS: We describe our experience with 271 patients undergoing staff-assisted HD in the NH setting from 1 January 2001 to 30 June 2004. Acceptance into the programme required that the patients were mentally responsive, haemodynamically stable without sepsis and not be considered terminal or in hospice. RESULTS: Mean age at entry was 70.5+/-12.1 years, 53% were female, 54% were white and 34% black. Main causes of end-stage renal disease (ESRD) were diabetes mellitus (DM, 48%) and hypertension (HTN, 25%). Comorbid conditions included HTN-90%, DM-65%, coronary artery disease-54%, congestive heart failure-59%, cerebrovascular accident-31%, and 40% could not ambulate. The average time on chronic dialysis prior to entering the nursing programme was 18+/-27 months, and the median time was 4 months (range: 0.1-191 months). The average time in the NH programme was 2.9+/-3.6 months (median: 1.6 months, range: 0.1-24 months). During the study period 42% of the patients died, 37% were discharged from the NH, 4.4% withdrew from dialysis, and 16% remained active in the programme. Patient survival from entry into the NH programme was 82% at 1 month, 64% at 3 months, 38% at 6 months and 26% at 12 months (median survival of 4.1 months). However, the patient survival from initiation of chronic dialysis was 75% at 6 months, 66% at 12 months and 38% at 60 months with a median survival of 3.4 years. When evaluating patients based on the duration of chronic dialysis prior to entering the NH programme we found that established HD patients (on HD>or=12 months prior to programme entry) had fewer myocardial infarctions (15 vs 26%, P=0.05), more amputations (19 vs 8%, P=0.01), higher creatinine (6.7 vs 4.7 mg/dl, P<0.01), haemoglobin (11.1 vs 10.5 g/dl, P<0.01) and albumin (3.2 vs 3.0 g/dl, P=0.09) compared with new HD patients (on HD相似文献   

Haemolysis in haemodialysis patients: evidence for impaired defence mechanisms against oxidative stress.

BACKGROUND: Uraemic patients have a decreased ability to withstand oxidative stress. It is postulated that their antioxidant capacity is reduced, yet the mechanism remains unclear. Recently 33 haemodialysis (HD) patients were exposed to chloramine contamination in the water supply. This led to haemolysis in 24 patients, while nine were unaffected. In the former group haemoglobin decreased from 11.7+/-1.1 to 8.5+/- 1.4 g/dl (P<0.0001) and returned to 11.4+/-0.9 g/dl (P<0.0001) following recovery. During haemolysis, haptoglobin was 38.4+/-10.6 vs 138.1+/-8.3 ng/dl (P<0.0001) following recovery. METHODS: To explore the factors affecting the severity of haemolysis we studied extracellular and intracellular anti-oxidant defence mechanisms 3 months after recovery. In 29 patients and 20 controls we determined plasma glutathione (GSH), and the erythrocyte enzymes glutathione peroxidase (GSH-Px), glutathione reductase (GSH-Rx), and superoxide dismutase (SOD). Serum malondialdehyde (MDA) was measured as a marker of oxidative stress. RESULTS: Plasma GSH was lower in patients as compared to controls (5.49+/-0.26 vs 7.4+/-0.5 micromol/l, P<0.005). There was an inverse correlation between GSH and the degree of haemolysis (r=-0.42, P<0.02). Patients had higher GSH-Rx (4.64+/-0.15 vs 3.97+/-0.12 U/gHb, P<0.02), lower GSH-Px (29. 7+/-1.85 vs 35.5+/-1.62 U/gHb, P<0.001), and similar SOD (0.63+/-0. 02 vs 0.51+/-0.02 U/mgHb) as compared to controls. There was no correlation between the enzyme levels and the degree of haemolysis. MDA was higher in patients (2.37+/-0.07 vs 0.97+/-0.1 nmol/ml, P<0. 0001). There was a correlation between MDA and the years patients were on HD (r=0.43, P<0.02). CONCLUSIONS: These data indicate that HD patients have an impaired anti-oxidant response, which may be attributed in part, to plasma GSH deficiency. Patients with the lowest plasma GSH levels are more susceptible to oxidative stress and consequent haemolysis.     

New strategy to attenuate pulse wave velocity in haemodialysis patients.

BACKGROUND: Pulse wave velocity (PWV) is commonly elevated in haemodialysis (HD) patients having cardiovascular diseases. Disturbances in calcium-phosphate metabolism are among the established cardiovascular risk factors in HD patients. The present study was performed to assess the effect of sevelamer on PWV in HD patients. METHODS: Fifteen patients, who had been treated with calcium carbonate as a phosphate binder, were entered into the study. Changes in PWV during the 6 months before sevelamer administration were compared with PWV changes during 6 months of receiving sevelamer. Serum biochemistry parameters were also assessed. RESULTS: Compared with the preceding control period, the sevelamer period resulted in decreased serum calcium (9.9+/-0.1 to 9.6+/-0.1 mg/dl, n = 15; P<0.01) in association with reductions in oral calcium load (4.3+/-0.4 to 2.3+/-0.6 g/day; P<0.001). Serum phosphorus and whole parathyroid hormone remained unchanged. Sevelamer reduced serum total cholesterol (167+/-7 to 148+/-6 mg/dl; P<0.001) and LDL-cholesterol (85+/-8 to 65+/-7 mg/dl; P<0.001), without modifying HDL-cholesterol or triglycerides. Finally, sevelamer reversed the increase in PWV observed during the control period (from 46+/-16 to -20+/-9 cm/s/month; P<0.01). CONCLUSIONS: In chronic HD patients, sevelamer decreased serum total- and LDL-cholesterol as well as calcium. Moreover, our findings suggest that treatment with sevelamer attenuates the progressive increase in PWV observed during calcium carbonate treatment.     

Adolescent hemodialysis: results of the 2000 ESRD Clinical Performance Measures Project

In 2000, the Centers for Medicare and Medicaid Services (CMS), formerly known as the Health Care Financing Administration (HCFA) 2000 ESRD Clinical Performance Measures (CPM) Project, was expanded to obtain demographic characteristics and clinical information on all adolescent (age ≥12 years, <18 years) patients receiving in-center hemodialysis on 31 December, 1999. Of the 486 patients identified, 433 (89%) had the minimum required data submitted. Demographic characteristics included mean age of 15.8 years (±1.6 years). Forty-nine percent were white, 42% black; 21% were Hispanic. Congenital/urologic disease and focal and segmental sclerosis were the leading causes of end-stage renal disease. Forty-one percent had a catheter as their dialysis access, while 37% had an AV fistula and 22% an AV graft in place. The mean Kt/V was 1.47 (±0.38) and 79% had a mean calculated Kt/V≥1.2, although residual renal function was not included in this measurement. After multivariate logistic regression, male gender and black race were among the factors predictive of mean calculated Kt/V<1.2. The mean serum albumin was 3.85 g/dl (±0.51) in patients with bromcresol green measurements and 3.62 mg/dl (±0.52) in patients with bromcresol purple measurements. The mean hemoglobin was 10.99 g/dl (±1.6) and 55% had a mean hemoglobin ≥11 g/dl. After multivariate logistic regression, lower epoetin dose and mean serum albumin ≥3.5/3.2 g/dl (BCG/BCP) remained predictive of mean hemoglobin ≥11 g/dl. These data provide important information about the clinical status of adolescent hemodialysis patients in the United States. Continued data collection and analyses are planned to identify areas for potential improvement in patient care. Received: 21 May 2001 / Revised: 7 August 2001 / Accepted: 7 August 2001     

The impact of withdrawing ACE inhibitors on erythropoietin responsiveness and left ventricular hypertrophy in haemodialysis patients.

BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors have the capability of decreasing left ventricular mass index (LVMI) in chronic haemodialysis (HD) patients. On the other hand, recent reports provide conflicting information regarding the impact of ACE inhibitors on responsiveness to recombinant human erythropoietin (rHuEpo), and there are no data about the effect of withdrawing ACE inhibitors both on rHuEpo response and LVMI in HD patients. METHODS: ACE inhibitors were switched to another antihypertensive medication in 23 out of 68 patients in our HD unit who were receiving both rHuEpo and an ACE inhibitor for more than 1 year. Blood pressure at the pre- and post-dialysis phases, haematocrit levels and rHuEpo doses were determined at the end of the first and of the third years, and the LVMI was determined at the end of the third year. Statistical analyses were done in 15 patients in whom the study could be completed. RESULTS: The mean (+/-SD) haematocrit level was increased from 26.3+6.4% to 29.8+/-6.3% at the first year (P<0.05), and to 29.4+/-6.5% at the third year (P<0.05 vs before), while the mean dose of rHuEpo was decreased from 208.3+/-99.0 UI/kg/week to 141.0+/-91.8 at the first year (P=0.01), and to 141.4+/-81.0 at the third year (P=0.01 vs before). Administration of rHuEpo had been stopped in two patients at the end of the first year. The mean blood pressure level and the mean LVMI were not changed (P>0.05 vs before). There were no significant changes in dialysis parameters, iron status, plasma renin activities, and levels of aldosterone, intact parathyroid hormone, aluminum and erythropoietin. CONCLUSION: The findings of this small uncontrolled study indicate that withdrawal of ACE inhibitors in hypertensive chronic HD patients receiving rHuEpo may result in an increase in haematocrit level, and a decrease in dose of rHuEpo without any significant changes in the blood pressure level and LVMI. Controlled prospective studies are needed to clarify this issue.     

Use of Perflubron Emulsion to Decrease Allogeneic Blood Transfusion in High-blood-loss Non-Cardiac Surgery: Results of a European Phase 3 Study

Background: This single-blind randomized study in general surgery evaluated the efficacy of perflubron emulsion (PFC) as an artificial oxygen carrier being used to augment preoperative acute normovolemic hemodilution to reduce and avoid transfusion of both allogeneic erythrocytes and erythrocytes from preoperative autologous donation compared with standard of care.

Methods: Subjects (N = 492) with hemoglobin concentrations of 12-15 g/dl undergoing noncardiac surgical procedures with 20 ml/kg or greater expected blood loss were randomized into two groups. Control patients were transfused intraoperatively at a hemoglobin concentration less than 8.0 +/- 0.5 g/dl or at protocol-defined, physiologic triggers. PFC-treated patients first underwent acute normovolemic hemodilution to hemoglobin of 8.0 +/- 0.5 g/dl, followed by dosing with perflubron emulsion (1.8 g/kg). When hemoglobin reached less than 6.5 +/- 0.5 g/dl, an additional 0.9-g/kg dose was given. PFC patients were transfused at hemoglobin less than 5.5 +/- 0.5 g/dl or at predefined physiologic triggers. After surgery, hemoglobin was maintained at 8.5 +/- 0.5 g/dl or greater in all patients until discharge. Efficacy endpoints included the number of allogeneic and preoperative autologous donation units transfused and the percentage of subjects avoiding transfusion.

Results: Both groups had similar hemoglobin concentrations at screening (13.5 +/- 1.0 g/dl) and at discharge: 10.8 +/- 1.2 g/dl (PFC) and 11.1 +/- 1.3 g/dl (control). At 24 h, more patients in the PFC group avoided allogeneic and preoperative autologous donation erythrocyte transfusions (53%vs. 43%, P < 0.05), and fewer erythrocytes were transfused (1.5 +/- 4.8 vs. 2.1 +/- 3.9 units; median, 0 vs. 1 unit;P = 0.013). By day of discharge, these differences were not significant in the intent-to-treat population, but overall there were less allogeneic and preoperative autologous donation erythrocyte transfusions in the PFC group (696 vs. 846 units). In the protocol-defined target population (n = 330 subjects with blood loss >= 20 ml/kg), significantly greater avoidance of any erythrocyte transfusion was maintained through day of hospital discharge (26%vs. 16% in the PFC and control groups, respectively;P < 0.05), and there was also a significant reduction in the number of erythrocyte units transfused (3.4 +/- 2.9 vs. 4.9 +/- 2.4 units; median 2 vs. 4 units;P < 0.001). Adverse events rates were similar in the PFC (86%) and control (81%) groups; however, more serious adverse events were reported in the PFC group (32%) than in controls (21%;P < 0.05). Overall mortality was 3%, and the difference between groups (PFC, 4%vs. controls, 2%) was not statistically significant.     

A prospective multicentre study of the role of anaemia as a risk factor in haemodialysis patients: the MAR Study.

BACKGROUND: Retrospective studies have shown hospitalization and mortality rates during haemodialysis (HD) to be associated with anaemia. METHODS: The prospective, multicentre Morbidity-and-mortality Anaemia Renal (MAR) study was designed to establish the burden of anaemia by controlling for other risk factors. Charlson index was used for comorbid adjustment. Finally, 1428 patients from 119 centres (60% men, aged 64.4 years, time on HD 15.3 months, Charlson comorbidity index 6.5 +/- 2.3) completed follow-up. They had hypertension (75.8%), diabetes mellitus (25.9%), heart failure (13.9%) and coronary disease (16.7%). Of the total patients, 94.8% were receiving erythropoietin (111.6 +/- 70.6 U/kg/week) and 76.7% i.v. iron, and haemoglobin (Hb) at inclusion was 11.7 +/- 1.5 g/dl. RESULTS: Hospitalization rate was 1.1 admissions/patient/year. Yearly mortality was 12% [35% cardiovascular (CV)]. The relative risk and confidence interval (CI) for hospitalization and death were 0.86 (0.81-0.91) and 0.82 (0.73-0.91), respectively, per 1 g/dl increase in initial Hb after adjustment for comorbidity, vintage, aetiology, access type, albumin and Kt/V. The probability of remaining free from hospitalization (CI) was 0.34 (0.27-0.41) for initial Hb <10 g/dl, 0.47 (0.41-0.53) for Hb 10-11 g/dl, 0.54 (0.49-0.59) for Hb 11-12 g/dl, and 0.63 (0.59-0.67) for Hb >12 g/dl. Same analysis for patient survival was 0.77 (0.71-0.83) for Hb <10 g/dl vs 0.82 (0.77-0.87) for Hb 10-11 vs 0.89 (0.86-0.92) for Hb 11-12 vs 0.92 (0.90-0.94) for Hb > 12 g/dl, P < 0.001. The Cox regression model for hospitalization-free survival included the risk factors initial Hb (relative risk 0.86 per 1 g/dl increase, P < 0.001) Charlson, albumin and prior CV event. CONCLUSION: Hb level predicted 1-year-survival and hospitalization. This effect persisted after adjustment for comorbidity and other prognostic factors.     

Anesthesia and blood loss in preterm cesarean section: comparison between general and regional anesthesia

Changes in maternal hemoglobin concentrations after cesarean section performed before 35 weeks gestation were analyzed according to the type of anesthesia in a case-control retrospective study. There were 30 mothers who received general anesthesia (GA group) and 30 mothers who received regional anesthesia (RA group). The groups were matched for gestational age at delivery, type of uterine incision, and the use of tocolytic therapy (isoxuprine) before delivery. The indications for delivery were preterm labor or fetal/maternal complications following premature rupture of membranes without labor. There was no significant difference between the GA and RA groups in the pre-operative hemoglobin (11.9+/-1.4 vs 11.6+/-1.1 g/dl) or postoperative hemoglobin (11.1+/-1.7 vs 11.3+/-1.2 g/dl). The GA group, however, demonstrated a significant fall in the postoperative hemoglobin (P < 0.05). The GA group also had a higher incidence of a drop in hemoglobin of > 10% compared to the RA group (46.7% vs 20.0%, P < 0.05). Our results suggest that general anesthesia may be associated with more blood loss than regional anesthesia in cesarean sections performed before 35 weeks.     

Clinical characteristics associated to atrial fibrillation in chronic hemodialysis patients

BACKGROUND: Atrial fibrillation (AF) is the most common sustained arrhythmia diagnosed in non-uremic patients and its prevalence increases in older subjects, however, information concerning AF in dialysis patients is scarce. Therefore, we carried out a prospective cross-sectional study from September 1996 to December 1996 in order to evaluate the prevalence and some of the clinical characteristics associated to AF in hemodialysis (HD) patients. SUBJECTS AND METHODS: 316 HD patients (age 63 +/- 12 years, dialysis duration 69 +/- 71 months) treated in three different hospital-based units were studied. Standard 12-lead electrocardiograms (ECGs) carried out in the interdialytic day during the study period were reviewed. Data concerning age, history of ischemic heart disease (IHD), cerebrovascular disease (CVD), peripheral vascular disease (PVD), presence of diabetes, smoking history and antihypertensive therapy were collected. Systolic and diastolic blood pressure, fasting cholesterol and triglycerides, albumin and hemoglobin were also derived from the clinical records. Performance status was assessed by Karnofsky index (Ki). RESULTS: 74 patients (23.4%) had persistent AF, i.e. presence of AF in all (at least two) ECGs performed in the study time. Patients with AF were older (age 69 +/- 10 vs 62 +/- 12 years, p < 0.001), had lower Ki (54 +/- 20 vs 68 +/- 17, p < 0.01), cholesterol (182 +/- 46 vs 198 +/- 52 mg/dl, p < 0.01) and albumin (3.9 +/- 0.5 vs 4.1 +/- 0.5 g/dl, p < 0.001) compared to those with no AF. Prevalence of IHD (44.5% vs 19%, p < 0.05) and PVD (23% vs 11%, p < 0.05) was higher among AF patients. Logistic regression analysis showed that IHD (p < 0.001) and Ki (p < 0.01) were independently associated to AF. CONCLUSION: We conclude that AF is a frequent arrhythmia in HD patients treated in hospital-based dialysis units, especially in those with low performance status. It appears to be associated to the atherosclerotic damage of coronary arterial tree. Prospective studies are necessary to assess whether it could contribute to cardiovascular morbidity and mortality in end-stage renal disease.     

Prevalence of protein malnutrition in children maintained on peritoneal dialysis

A paucity of outcome measures exist for children, making evidence-based treatment guidelines difficult to establish. Serum albumin has been identified as a surrogate marker for nutritional status and morbidity/mortality in patients with end-stage renal disease (ESRD). We hypothesized that the prevalence of low serum albumin (<2.9 g/dl) in children on peritoneal dialysis (PD) may be greater, making this population at risk. Patient data were collected prospectively over 24 months (1999-2000) from all children (1-18 years) maintained on either hemodialysis (HD) or PD within the six-state New England area; 64 observations were made on 39 children on PD over the 2-year period. The mean age was 11.7+/-4.7 years (mean+/-SD). The prevalence of low serum albumin in children was 35.9% (23/64 observations) compared with 19.5% (712/3,719 observations) in adult Network ESRD patients on PD ( P<0.004). None of the 32 children (47 observations) maintained on HD exhibited low serum albumin during the data collection period. The prevalence of low serum albumin in adult HD patients was 5.5%. Dietary protein intake was estimated from a calculated protein catabolic rate (PCR). PCRs in children treated with both PD and HD were similar, averaging 1.1+/-0.4 g/kg per day (mean+/-SD). Thus, children maintained on PD are at greater risk of protein malnutrition compared with peers treated with HD and adults on PD or HD. A PCR of approximately 1 g/kg per day may not be adequate to maintain nutrition.     

Subjective quality of life assessment in hemodialysis patients at different levels of hemoglobin following use of recombinant human erythropoietin.

The quality of life of 12 hemodialysis (HD) patients was assessed in a prospective, blinded, cross-over fashion before treatment with recombinant human erythropoietin (r-HuEPO) and at two different levels of hemoglobin (Hb, 9 and 12 g/dl) by means of an interviewer-based questionnaire, the sickness impact profile (SIP). Patients were matched into two groups with no significant difference for age, weight, Hb (6.3 +/- 0.5, mean +/- SEM, group A, vs. 6.4 +/- 0.9 group B), length of hemodialysis or number of years of prior transplantation. SIP was assessed prior to treatment, after reaching the first target Hb (Hb 9 g/dl group A, 12 g/dl group B), after 4 months at that target Hb and after 4 months at the alternative target Hb for each group. For all patients, there was a highly significant improvement in quality of life as assessed by lower SIP scores between the initial and second assessments. This was evident for the physical (8.9 +/- 1.4 vs. 2.8 +/- 1.0; p less than 0.001) and psychosocial (14.9 +/- 3.9 vs. 4.4 +/- 1.1; p less than 0.01) dimensions. Total scores (16.3 +/- 2.4 vs. 5.7 +/- 0.9; p less than 0.001) showed similar changes, reflecting significant improvement in 10 of 12 possible categories between the first two assessments (p less than 0.05 to p less than 0.001). Improved scores were maintained but did not change appreciably after the 2nd assessment. There was no significant difference in any score (category, dimensional or total) obtained after 4 months at Hb 9 g/dl compared to those after the same period at Hb 12 g/dl.(ABSTRACT TRUNCATED AT 250 WORDS)     

Rise in serum albumin and creatinine in the first half year on hemodialysis

Rise in serum albumin and creatinine in the first half year on hemodialysis. BACKGROUND: Serum albumin and creatinine have been reported to rise in new hemodialysis patients; however, these trends have not been quantitated in a stable cohort, and their determinants and prognostic value are unknown. METHODS: This study examined the changes in monthly values of serum albumin and creatinine over the first half year of hemodialysis in 115 patients who survived to the start of the sixth month. After verifying that the trends were approximately linear, we calculated the rates of rise (slope) of six predialysis values of serum albumin (months 1 through 6) and of creatinine (months 2 through 7) and examined their associations with age, diabetes, race, baseline 24-hour urine protein and creatinine excretion, and survival during the latter half of the first year. RESULTS: Serum albumin rose by 13% over months 1 through 6 [0.08 +/- 0.12 (SD) g/dl/month, P < 10-9 vs. zero slope]. Patients who survived the entire year had higher mean values for both serum albumin (month 1, P < 0.003; months 3 through 6, P < 10-3) and rate of rise of albumin (0.09 +/- 0.11 g/dl/month vs. 0.01 +/- 0.13 g/dl/month, P < 0.005) than patients who died during months 6 through 12, but the slope was not an independent predictor of survival after adjusting for serum albumin concentration. Baseline proteinuria correlated inversely with serum albumin measured at the first and second months (P < 0.005) and directly with the albumin slope (r = 0.49, P < 10-5). Serum creatinine rose by 12% between months 2 through 7 (0.12 +/- 0.47 mg/dl/month, P < 0.02). Survivors had a significantly higher mean baseline creatinine excretion (P < 0. 03) and serum creatinine (month 2, P < 0.03; months 3 through 7, P < 0.01) but only a marginally higher rate of rise of serum creatinine (0.16 +/- 0.47 mg/dl/month vs. -0.07 +/- 0.48 mg/dl/month, P < 0.06) than patients who died during the second half of the year. Baseline urinary creatinine excretion correlated directly with serum creatinine at month 2 (P < 0.01) and more strongly at months 3 through 7 (P < 10-3), as well as correlating with the creatinine slope (r = 0.26, P < 0.03). CONCLUSIONS: Serum albumin and creatinine rose by 12 to 13% during the first half year of hemodialysis in a stable cohort. The slope of serum albumin versus time predicted survival, but it was not as predictive as the absolute albumin concentration. The pattern of correlations of baseline urinary protein and creatinine excretion with the respective monthly serum values of albumin and creatinine and their slopes is consistent with the hypothesis that as residual renal function declines, progressive retention of protein and creatinine contributes to the respective rises in serum albumin and creatinine.