Randomized Controlled Trial of Icodextrin versus Glucose Containing Peritoneal Dialysis Fluid

Background and objectives: While peritoneal dialysis with icodextrin is commonly used in patients with poor peritoneal membrane characteristics, the data on the usefulness of this solution in patients with lower transport characteristics are limited. The study was designed to compare icodextrin to glucose in Chinese prevalent peritoneal dialysis patients of different peritoneal transport characteristics (PET) categories.Design, setting, participants, & measurements: This was a randomized, double-blind, perspective control study. Stable prevalent continuous ambulatory peritoneal dialysis (CAPD) patients were randomized to either 7.5% icodextrin (ICO) or 2.5% glucose (GLU) solution for 4 wk. Peritoneal membrane function was measured to define PET category in baseline. Creatinine clearance (Ccr), urea nitrogen clearance (C_BUN), ultrafiltration (UF) during the long night dwell, dialysate, and metabolic biomarkers were measured at baseline, 2, and 4 wk. UF, Ccr, and C_BUN were compared among different PET categories.Results: A total of 201 CAPD patients were enrolled in the study. There were no baseline differences between the groups. Following 2 and 4 wk of therapy, Ccr, C_BUN, and UF were all significantly higher in the ICO versus the GLU group. Additionally, switching to ICO resulted in a significant increase in UF in high, high-average, and low-average transporters as compared with baseline. The extent of increased UF was more obvious in higher transporters. Blood cholesterol level in the ICO group decreased significantly than that in the GLU group.Conclusion: Compared with glucose-based solution, 7.5% icodextrin significantly improved UF and small solute clearance, even in patients with low-average peritoneal transport.Control of water and control of solutes are the main goals of current dialysis therapies. In continuous ambulatory peritoneal dialysis (PD), where the peritoneal membrane functions as an endogeneous filter, peritoneal membrane transport characteristics are paramount. Interestingly, clinical experience and scientific studies (1,2) have shown significant differences in these characteristics between Asian and non-Asian patients. Peritoneal membrane function (D/Pcr) in Asian patients is much lower than in non-Asian patients. Indeed, as peritoneal transport is an independent predictor of patient and technique survival (3), the well-known difference in these parameters between Asians and non-Asians on PD may at least partly be due to differences in the peritoneal cavity.In PD patients, loss of peritoneal membrane integrity gradually occurs with PD therapy and leads to decreased ultrafiltration (UF) (4). This is commonly countered by the introduction of colloid icodextrin solution in the PD regimen (5–9). However, icodextrin was recently introduced in Asia and is not available in mainland China. Thus, there is a paucity of data regarding the performance of this compound in Asian patients, with their unique transport characteristics.We conducted a randomized, controlled multi-center trial comparing icodextrin and glucose in ethnically Chinese patients, focusing on short-term improvement of ultrafiltration in different peritoneal transport characteristics and metabolic changes.     

分析糖尿病肾病和非糖尿病肾病腹膜透析患者容量负荷及营养状态

目的 观察对比糖尿病肾病和非糖尿病肾病腹膜透析患者容量负荷及营养状态.方法 该院2019年2月—2020年2月收治的108例行腹膜透析治疗患者为该次研究对象,按照患者疾病类型是否为糖尿病肾病分为A组(54例糖尿病肾病)与B组(54例非糖尿病肾病),比较两组患者容量负荷及营养状态.结果 A组患者治疗6个月后血压、尿量以及...     

Improving Medication Adherence in Patients with Hypertension: A Randomized Trial

Background and Purpose

In patients with hypertension, medication adherence is often suboptimal, thereby increasing the risk of ischemic heart disease and stroke. In a randomized trial, we investigated the effectiveness of a multifaceted pharmacist intervention in a hospital setting to improve medication adherence in hypertensive patients. Motivational interviewing was a key element of the intervention.

Methods

Patients (n = 532) were recruited from 3 hospital outpatient clinics and randomized to usual care or a 6-month pharmacist intervention comprising collaborative care, medication review, and tailored adherence counseling including motivational interviewing and telephone follow-ups. The primary outcome was composite medication possession ratio (MPR) to antihypertensive and lipid-lowering agents, at 1-year follow-up, assessed by analyzing pharmacy records. Secondary outcomes at 12 months included persistence to medications, blood pressure, hospital admission, and a combined clinical endpoint of cardiovascular death, stroke, or acute myocardial infarction.

Results

At 12 months, 20.3% of the patients in the intervention group (n = 231) were nonadherent (MPR <0.80), compared with 30.2% in the control group (n = 285) (risk difference −9.8; 95% confidence interval [CI], −17.3, −2.4) and median MPR (interquartile range) was 0.93 (0.82-0.99) and 0.91 (0.76-0.98), respectively, P = .02. The combined clinical endpoint was reached by 1.3% in the intervention group and 3.1% in the control group (relative risk 0.41; 95% CI, 0.11-1.50). No significant differences were found for persistence, blood pressure, or hospital admission.

Conclusions

A multifaceted pharmacist intervention in a hospital setting led to a sustained improvement in medication adherence for patients with hypertension. The intervention had no significant impact on blood pressure and secondary clinical outcomes.     

Glycemic Control and Survival in Peritoneal Dialysis Patients with Diabetes Mellitus

Summary

Background and objectives

The optimal target for glycemic control has not been established for diabetic peritoneal dialysis (PD) patients.

Design, setting, participants, & measurements

We examined mortality-predictability of hemoglobin A1c random serum glucose in a contemporary cohort of diabetic PD patients treated in DaVita dialysis clinics July 2001 through June 2006 with follow-up through June 2007.

Results

We identified 2798 diabetic PD patients with A1c data. Serum glucose correlated with A1C (r = 0.51). Adjusted all-cause death hazard ratio and 95% confidence interval for baseline A1c increments of 7.0 to 7.9%, 8.0 to 8.9%, 9.0 to 9.9%, and ≥10%, compared with 6.0 to 6.9% (reference), were 1.13 (0.97 to 1.32), 1.05 (0.88 to 1.27), 1.06 (0.84 to 1.34), and 1.48 (1.18 to 1.86); and for time-averaged A1c values were 1.10 (0.96 to 1.27), 1.28 (1.07 to 1.53), 1.34 (1.05 to 1.70), and 1.81 (1.33 to 2.46), respectively. The A1c-mortality association was modified by hemoglobin level such that higher all-cause mortality was evident only in nonanemic patients. Similar but non-significant trends in cardiovascular death risk was found across A1c increments. Adjusted all-cause death HR for time-averaged blood glucose 150 to 199, 200 to 249, 250 to 299, and ≥300 mg/dl, compared with 60 to 99 mg/dl (reference), were 1.02 (0.70 to 1.47), 1.12 (0.77 to 1.63), 1.45 (0.97 to 2.18), and 2.10 (1.37 to 3.20), respectively.

Conclusions

Poor glycemic control appears associated incrementally with higher mortality in PD patients. Moderate to severe hyperglycemia is associated with higher death risk especially in certain subgroups.     

Few Outflow Problems With a Self-locating Catheter for Peritoneal Dialysis: A Randomized Trial

We developed a technique for direct start of peritoneal dialysis. Using a coiled or straight Tenckhoff catheter often results in obstruction of flow. A self-locating Wolfram catheter is on the market. It is not clarified if this results in a benefit.The primary aim of this study was to perform a randomized investigation to clarify if the use of a self-locating peritoneal dialysis (PD) catheter would result in different flow problems than a straight Tenckhoff catheter.A total of 61 insertions were made who were randomized and received either a straight Tenckhoff (n = 32) or a self-locating Wolfram catheter (n = 29).A previously described operation technique allowed immediate postoperative start of dialysis. Seven straight Tenckhoff catheters had to be changed into self-locating catheters, and none vice versa, due to flow problems (P = 0.011). An early leakage resulted in temporarily postponed PD in 4 patients.This study showed that using the present operation technique the self-locating PD-catheter causes fewer obstruction episodes than a straight Tenckhoff catheter. This facilitates immediate postoperative start of PD.     

Randomized,Double‐Blind,Placebo‐Controlled Trial of Spironolactone for Hypokalemia in Continuous Ambulatory Peritoneal Dialysis Patients

The incidence of hypokalemia in continuous ambulatory peritoneal dialysis (CAPD) patients is about 15–60%, leading to significant complications. There is no standard treatment other than potassium supplement in this setting. The aim of this study was to evaluate effect of spironolactone 25 mg/day in CAPD patients who have a history of hypokalemia. This is a randomized, double‐blind, placebo‐controlled, cross‐over study in CAPD patients who had a history of hypokalemia. Study intervention is 4 weeks of oral spironolactone 25 mg/day or placebo, cross‐over after a 2‐week wash‐out period. The primary outcome was the difference of serum potassium before and after 4 weeks of spironolactone treatment. Serum potassium was measured every 2 weeks, serum magnesium, urine and peritoneal fluid potassium measured before and after each treatment period. We enrolled 24 patients, and 20 completed the cross‐over study. Ten patients were anuric. The total doses of potassium supplement were the same during the study period. Serum potassium levels before and after study intervention were not significantly different in both groups (4.23 ± 0.64 vs. 3.90 ± 0.59 mEq/L for spironolactone P = 0.077 and 3.84 ± 0.62 vs. 3.91 ± 0.52 for placebo P = 0.551). Total 24‐h potassium, magnesium, sodium excretion, urine volume and ultrafiltration volume were not affected by spironolactone or placebo. There was one episode of hyperkalemia (5.6 mEq/L) during the spironolactone treatment period. Spironolactone 25 mg/day does not have a significant effect on serum potassium or urine and peritoneal excretion rate in CAPD patients who have a history of hypokalemia.     

Difficulty in Improving Malnutrition and Low‐grade Inflammation in Diabetic Patients on Peritoneal Dialysis

Continuous ambulatory peritoneal dialysis (CAPD) is commonly used for renal replacement therapy in diabetes mellitus (DM) patients. We investigated the changes of peritoneal transport characteristics, nutritional status, and adequacy and inflammation parameters in diabetic CAPD patients (N = 17) compared to non‐diabetic patients (N = 23). Peritoneal equilibrium testing, nutritional, biochemical, and anthropometric parameters and adequacy were prospectively assessed at 1 (baseline), 6 and 12 months after initiating CAPD. The levels of several nutritional parameters were lower and did not change in DM patients over time (P < 0.05) and significantly improved in the non‐DM patients over time (P < 0.05). Total weekly creatinine clearance and residual renal function exhibited a rapid decline (P < 0.05) and inflammation parameter levels were higher in DM patients (P < 0.05). Our results showed the difficulty in improvement of nutritional status and inflammatory parameters in diabetic patients during at least the first year of CAPD compared to non‐DM patients.     

论糖尿病肾病血液透析患者家庭护理干预的效果研究

目的探讨糖尿病肾病血液透析患者家庭护理干预的效果。方法选取该院2013年1月—2015年1月收治的糖尿病肾病终末期需要在该院进行血液透析的患者70例作为研究对象,随机分为观察组与对照组各35例,对两组患者进行血液透析,对照组患者采取常规护理,观察组患者采取家庭护理干预措施。对比两组患者的护理效果。结果观察组患者在自我护理能力、病情自我观察能力、用药安全、社会活动参与能力、作息规律等健康行为上明显优于对照组。组间比较差异有统计学意义(P0.05)。观察组在失衡综合征、内瘘感染、心力衰竭、水肿、低血压、低血糖、高血压等并发症发生上明显少于对照组,组间比较差异有统计学意义(P0.05)。结论家庭护理干预对糖尿病肾病血液透析患者的治疗具有明显的效果,能够减少患者并发症的发生机率,改善患者的自身健康行为,促进患者的康复,在临床上值得推广。     

Stapled Technique for Acute Thrombosed Hemorrhoids: A Randomized,Controlled Trial with Long-Term Results

Purpose This study was designed to compare stapled vs. conventional hemorrhoidectomy for patients with acute thrombosed hemorrhoids. Methods Forty-one patients with acute thrombosed hemorrhoids were randomized into: 1) stapled hemorrhoidectomy (PPH group; n = 21), and 2) open hemorrhoidectomy (open group; n = 20). Emergency surgery was performed with perioperative data and complications were recorded. Patients were followed up by independent assessors to evaluate pain, recurrence, continence function, and satisfaction at regular intervals. Results The median follow-up for the PPH group and open group were 59 and 56 weeks, respectively. There was no significant difference in terms of the hospital stay, complication rate, and continence function; however, the mean pain intensity in the first postoperative week was significantly less in the PPH group (4.1 vs. 5.7, P = 0.02). Patients in the PPH group recovered significantly faster in terms of the time to become analgesic-free (4 vs. 8.5 days, P < 0.01), time to become pain-free (9 vs. 20.5 days, P = 0.01), resumption of work (7 vs. 12.5 days, P = 0.01), and time for complete wound healing (2 vs. 4 weeks, P < 0.01). On long-term follow-up, significantly fewer patients in the PPH group complained of recurrent symptoms (0 vs. 5, P = 0.02). The overall symptom improvement and patients’ satisfaction were significantly better in the PPH group (90 vs. 80 percent, P = 0.03 and +3 vs. +2, P < 0.01 respectively). Conclusions Stapled hemorrhoidectomy is safe and effective for acute thrombosed hemorrhoids. Similar to elective stapled procedure, emergency stapled excision has greater short-term benefits compared with conventional excision: diminished pain, faster recovery, and earlier return to work. Long-term results and satisfaction were excellent. Presented at the Annual Scientific Meeting of Hong Kong Society for Coloproctology, Hong Kong, January 14, 2006, at the Conjoined Annual Scientific Meeting of Royal College of Surgeon of Edinburg and The College of Surgeons of Hong Kong, Hong Kong, October 10 to 13, 2006, and at Annual Scientific Meeting of the Society of Endoscopic and Laparoscopic Surgeons of Asia, Seoul, Korea, October 18 to 21, 2006.     

The Safety of Eplerenone in Hemodialysis Patients: A Noninferiority Randomized Controlled Trial

Background and objectives

Mineralocorticoid receptor antagonism reduces morbidity and mortality in patients with heart failure, but the safety of these drugs in patients receiving dialysis is unclear. This study evaluated whether hyperkalemia and/or hypotension limited the use of eplerenone, a selective mineralocorticoid receptor antagonist, in hemodialysis patients.

Design, setting, participants, & measurements

This was a randomized controlled trial of prevalent patients receiving hemodialysis at five Canadian centers. Participants were randomly allocated to 13 weeks of eplerenone titrated to 50 mg daily (n=77) or a matching placebo (n=77). The primary outcome was permanent discontinuation of the drug because of hyperkalemia or hypotension. Secondary outcomes included hyperkalemia, hypotension, and cardiovascular events.

Results

Seventy-five eplerenone-treated patients and 71 placebo-treated patients were included in the per protocol population. The primary outcome occurred in three patients (4.0%) in the eplerenone group and two (2.8%) in the placebo group, for an absolute risk difference of 1.2 percentage points (95% confidence interval, −4.7 to 7.1 percentage points). Eplerenone was interpreted as noninferior to placebo with respect to the primary outcome (i.e., a discontinuation rate for these reasons >10% was excluded). In the eplerenone group, nine patients (11.7%) developed hyperkalemia (potassium level >6.5 mEq/L), compared with two patients (2.6%) in the placebo group (relative risk, 4.5; 95% confidence interval, 1.0 to 20.2). There was no significant effect on predialysis or postdialysis BP.

Conclusion

Eplerenone increased the risk of hyperkalemia but did not result in an excess need to permanently discontinue the drug. Further trials are required to determine whether mineralocorticoid receptor antagonism improves cardiovascular outcomes in patients receiving long-term dialysis.     

Nutritional Vitamin D Supplementation in Dialysis: A Randomized Trial

Background and objectives

Vitamin D (25-hydroxyvitamin D; 25[OH]D) deficiency is common in patients initiating long-term hemodialysis, but the safety and efficacy of nutritional vitamin D supplementation in this population remain uncertain.

Design, setting, participants, & measurements

This randomized, placebo-controlled, parallel-group multicenter trial compared two doses of ergocalciferol with placebo between October 2009 and March 2013. Hemodialysis patients (n=105) with 25(OH)D levels ≤32 ng/ml from 32 centers in the Northeast United States were randomly assigned to oral ergocalciferol, 50,000 IU weekly (n=36) or monthly (n=33), or placebo (n=36) for a 12-week treatment period. The primary endpoint was the achievement of vitamin D sufficiency (25[OH]D >32 ng/ml) at the end of the 12-week treatment period. Survival was assessed through 1 year.

Results

Baseline characteristics were similar across all arms, with overall mean±SD 25(OH)D levels of 21.9±6.9 ng/ml. At 12 weeks, vitamin D sufficiency (25[OH]D >32 ng/ml) was achieved in 91% (weekly), 66% (monthly), and 35% (placebo) (P<0.001). Mean 25(OH)D was significantly higher in both the weekly (49.8±2.3 ng/ml; P<0.001) and monthly (38.3±2.4 ng/ml; P=0.001) arms compared with placebo (27.4±2.3 ng/ml). Calcium, phosphate, parathyroid hormone levels, and active vitamin D treatment did not differ between groups. All-cause and cause-specific hospitalizations and adverse events were similar between groups during the intervention period. Lower all-cause mortality among ergocalciferol-treated participants was not statistically significant (hazard ratio, 0.28; 95% confidence interval, 0.07 to 1.19).

Conclusions

Oral ergocalciferol can increase 25(OH)D levels in incident hemodialysis patients without significant alterations in blood calcium, phosphate, or parathyroid hormone during a 12-week period.     

Effects of Spironolactone on Dialysis Patients With Refractory Hypertension: A Randomized Controlled Study

The purpose of this study was to evaluate the effects of spironolactone on dialysis patients with refractory hypertension and possible adverse effects. This was a 12‐week prospective, randomized, double‐blind trial of 82 patients randomly assigned to 12‐week treatment with 25 mg/d spironolactone or placebo as add‐on therapy. Visits were scheduled at the start of treatment and after 12 weeks. Measurements of 24‐hour ambulatory blood pressure (BP) monitoring and morning BP were performed. After 12 weeks, spironolactone significantly improved refractory hypertension. Average placebo‐corrected morning BP was reduced by 16.7/7.6 mm Hg. Mean 24‐hour ambulatory BP was reduced by 10.9/5.8 mm Hg. In contrast, serum aldosterone levels in the spironolactone group slightly increased and serum potassium levels insignificantly increased. This study has demonstrated that spironolactone (50 mg) safely and effectively reduces BP in patients with refractory hypertension undergoing dialysis.