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.     

Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center,Randomized Study

ObjectivesThis study aimed to compare the efficacy and safety of the distal transradial approach (dTRA) versus the conventional transradial approach (TRA) for coronary angiography and percutaneous coronary interventions.BackgroundThe recommended approach for coronary procedures is TRA. However, it is associated with radial artery occlusion (RAO). The dTRA could potentially decrease the incidence of RAO.MethodsOne thousand forty-two consecutive patients were randomized (1:1) to right dTRA or TRA. The primary endpoint was the rate of RAO, which was evaluated by Doppler ultrasound at 60 days after randomization.ResultsFive hundred eighteen and 524 patients were randomized to dTRA and TRA, respectively. Follow-up Doppler evaluation of the radial artery was accomplished in 404 (78.0%) patients in the dTRA group and 392 (74.8%) in the TRA group. The rate of RAO was significantly reduced in the dTRA group compared with TRA group (3.7% vs 7.9%, respectively; P = 0.014). The rate of successful sheath insertion was lower in the dTRA group compared with the TRA group (78.7% vs 94.8%, respectively; P < 0.001). More punctures (median = 2 [IQR: 1-3] vs median = 1 [IQR: 1-2]; P < 0.001) and a longer time (120 vs 75 seconds; P < 0.001) were required for sheath insertion in the dTRA group compared with the TRA group. The hemostasis time was shorter in the dTRA group compared with the TRA group (60 vs 120 minutes; P < 0.001). The dose area product was higher in the dTRA group (median = 32,729 in the dTRA vs 28,909 cGy/cm² in the TRA group; P = 0.02). No significant differences were observed in the secondary safety endpoints (bleeding [Bleeding Academic Research Consortium ≥2] and severe radial artery spasm).ConclusionsAccording to our study, dTRA was associated with a lower rate of forearm RAO, a shorter time of hemostasis, a higher crossover rate and dose area product, and a longer procedural time compared with TRA.     

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.     

Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial

ObjectivesThe aim of this study was to compare transradial access (TRA) with transfemoral access (TFA) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI).BackgroundTRA reduces the risk for vascular access complications but may make complex PCI, such as CTO PCI, more challenging.MethodsFORT CTO (Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion) (NCT03265769) was a prospective, noninferiority, randomized controlled study of TRA vs TFA for CTO PCI. The primary study endpoint was procedural success, defined as technical success without any in-hospital major adverse cardiovascular events. The secondary study endpoint was major access-site complications.ResultsBetween 2017 and 2021, 610 of 800 patients referred for CTO PCI at 4 centers were randomized to TRA (n = 305) or TFA (n = 305). Mean J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 0.1 vs 2.2 ± 0.1; P = 0.279), PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (1.3 ± 0.9 vs 1.1 ± 1.0; P = 0.058) and PROGRESS CTO complication (2.4 ± 1.8 vs 2.3 ± 1.8; P = 0.561) scores and use of the retrograde approach (11% vs 14%; P = 0.342) were similar in the TRA and TFA groups. TRA was noninferior to TFA for procedural success (84% vs 86%; P = 0.563) but had fewer access-site complications (2.0% vs 5.6%; P = 0.019). There was no difference between TFA and TRA in procedural duration, contrast volume, or radiation dose.COnclusionsTRA was noninferior to TFA for CTO PCI but had fewer access-site complications.     

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.     

Randomized Clinical Trial on Prevention of Radial Occlusion After Transradial Access Using Nitroglycerin: PATENS Trial

ObjectivesThe aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency.BackgroundThe TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO.MethodsThe authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 μg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound.ResultsA total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed re-establishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO.ConclusionsThe routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).     

Resistant Hypertension Optimal Treatment Trial: A Randomized Controlled Trial

The prevalence of resistant hypertension (ReHy) is not well established. Furthermore, diuretics, angiotensin‐converting enzyme inhibitors or angiotensin‐receptor blockers, and calcium channel blockers are largely used as the first 3‐drug combinations for treating ReHy. However, the fourth drug to be added to the triple regimen is still controversial and guided by empirical choices. We sought (1) to determine the prevalence of ReHy in patients with stage II hypertension; (2) to compare the effects of spironolactone vs clonidine, when added to the triple regimen; and (3) to evaluate the role of measuring sympathetic and renin‐angiotensin‐aldosterone activities in predicting blood pressure response to spironolactone or clonidine. The Resistant Hypertension Optimal Treatment (ReHOT) study ( ClinicalTrials.gov NCT01643434) is a prospective, multicenter, randomized trial comprising 26 sites in Brazil. In step 1, 2000 patients will be treated according to hypertension guidelines for 12 weeks, to detect the prevalence of ReHy. Medical therapy adherence will be checked by pill count monitoring. In step 2, patients with confirmed ReHy will be randomized to an open label 3‐month treatment with spironolactone (titrating dose, 12.5–50 mg once daily) or clonidine (titrating dose, 0.1–0.3 mg twice daily). The primary endpoint is the effective control of blood pressure after a 12‐week randomized period of treatment. The ReHOT study will disseminate results about the prevalence of ReHy in stage II hypertension and the comparison of spironolactone vs clonidine for blood pressure control in patients with ReHy under 3‐drug standard regimen.     

Prophylactic Pancreatic Stent Placement for Endoscopic Duodenal Ampullectomy: A Single-Center Retrospective Study

Background/Aims

We investigated the efficacy of prophylactic pancreatic stent placement for preventing postprocedure pancreatitis in patients undergoing endoscopic papillectomy.

Methods

This retrospective study included 82 consecutive patients who underwent endoscopic papillectomy for benign ampullary neoplasm at Samsung Medical Center between August 2002 and June 2011. The patients were subdivided into two groups, namely, those who received prophylactic pancreatic stent placement and those who did not. Patient demographics, baseline blood test, tumor characteristics, and endoscopic treatment data were collected. The primary endpoint was postprocedure pancreatitis.

Results

There was no difference in the development of postprocedure pancreatitis between the stent group and the no stent group (6/54, 10.5% and 2/28, 7.14%, respectively; p=1.00). At baseline, there were no significant differences between the two groups in terms of their risk factors for pancreatitis except pancreatic duct dye injection. The stent group was more likely to have dye injection than the nonstent group (100% vs 42.8%, p<0.001). However, in a logistic regression analysis, no significant difference was observed in the risk factors for pancreatitis including dye injection.

Conclusions

Our data suggest that routine prophylactic pancreatic duct stent placement in all patients undergoing endoscopic papillectomy may not be necessary and that large-scale prospective studies are required to identify the subgroup of patients who would benefit.     

A Registry-Based Randomized Trial Comparing Radial and Femoral Approaches in Women Undergoing Percutaneous Coronary Intervention: The SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) Trial

ObjectivesThis study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial.BackgroundWomen are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear.MethodsWomen undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population.ResultsThe trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access.ConclusionsIn this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236)     

Randomized Prospective Trial of Early Versus Delayed Feeding After Percutaneous Endoscopic Gastrostomy Placement

Objective : By convention, most clinicians delay feeding through the gastrostomy tube until 24 h after placement. However, evidence is lacking to support the rationale for such a delay in PEG use. This randomized, prospective study was designed to assess the safety of early feeding after PEG placement. Methods : One hundred-twelve patients referred for PEG were randomized to begin tube feedings at 4 h (group A) or at 24 h (group B) after placement. All patients received prophylactic antibiotics. Full-strength Isocal was administered with the following schedule: day 1,100 ml every 4 h for six feedings; day 2, 200 ml every 4 h for six feedings. Immediately before each scheduled feeding, gastric residual volume was recorded and the next feeding was withheld if the residual volume was > 50 percent (gastric retention). Patients were evaluated on day 1, day 2, day 7, and day 30 for major and minor complications. Results : The two groups were similar with regard to age, gender, baseline nutritional status, and indications for PEG placement. On the first day of feeding, 14 of 57 patients (25%) in group A, but only five of 55 patients (9%) in group B, had evidence of gastric retention,   p × 0.029  . The proportion of patients with high gastric residual volumes was not significantly different on day two. In group B, one death occurred because of aspiration of gastric contents on day 2. All other complications were minor and did not differ significantly between the two groups. Conclusions : Early initiation of PEG feedings is safe, well tolerated, and reduces cost by decreasing hospital stay.     

Bixalomer in Hyperphosphatemic Patients With Chronic Kidney Disease Not on Dialysis: Phase 3 Randomized Trial

Currently, calcium‐ or metal‐containing phosphate binders are available to treat hyperphosphatemia in predialysis patients with chronic kidney disease. Bixalomer, a non‐calcium, metal‐free phosphate binder, has not been studied in these patients. We evaluated the efficacy and safety of bixalomer versus placebo for treatment of hyperphosphatemia in Japanese predialysis patients with chronic kidney disease. This multicenter, randomized, double‐blind, phase 3 trial, randomized eligible patients 1:1 to receive bixalomer or placebo for 12 weeks. Bixalomer was started at 1500 mg/day and adjusted up to 7500 mg/day depending on serum phosphorus concentrations. The primary endpoint was change in serum phosphorus concentration from baseline to end of treatment. After a 4‐week pre‐investigational period, 163 patients (bixalomer: N = 81; placebo: N = 82) were randomized. The adjusted mean change (95% confidence interval) from baseline to end of treatment in serum phosphorus was significantly greater with bixalomer (–0.78 [–0.98, –0.57] mg/dL) versus placebo (0.20 [–0.00, 0.41] mg/dL); mean difference: –0.98 (–1.27, –0.69), P < 0.001. At end of treatment, 57.5% of bixalomer‐treated patients achieved target serum phosphorus concentrations, mean serum intact parathyroid hormone and fibroblast growth factor‐23 decreased, and there were no significant changes in corrected serum calcium. The safety and tolerability of bixalomer was similar to placebo. The most common drug‐related adverse events were gastrointestinal (>24% patients per group). There was a significant increase in bicarbonate concentrations with bixalomer versus placebo (P = 0.003). Bixalomer was superior to placebo for hyperphosphatemia in Japanese predialysis patients with chronic kidney disease and may constitute a new treatment option.     

Impact of Sex on Comparative Outcomes of Radial Versus Femoral Access in Patients With Acute Coronary Syndromes Undergoing Invasive Management: Data From the Randomized MATRIX-Access Trial

Objectives

This study sought to assess whether transradial access (TRA) compared with transfemoral access (TFA) is associated with consistent outcomes in male and female patients with acute coronary syndrome undergoing invasive management.

Safety and Efficacy of Transbrachial Access for Endovascular Procedures: A Single-Center Retrospective Analysis

BackgroundEndovascular procedures nowadays are generally performed via the femoral and radial artery. Although not routinely used by many, there is still an essential role for vascular interventions via brachial access. The technological advancement of endovascular devices leads to a significant increase of the variety of percutaneously treatable vascular pathology. The brachial artery approach nowadays is becoming crucial for complex procedures either as single access or in the context of mandatory double vascular approach for many complex interventions.ObjectiveTo evaluate the safety and efficacy of brachial artery access for diagnostic arteriography and endovascular interventions in different vascular territories in a single-center setting on the basis of a retrospective analysis of prospectively collected data in a large patient cohort.MethodsBetween 01/2013 and 09/2016, 11,274 endovascular procedures were performed in our hospital, 847 (7.5%) of them via brachial access, presenting the database for this study. All demographic, clinical, and periprocedural data were obtained prospectively and included in the computerized hospital records, and on this basis, a retrospective analysis was performed.ResultsWhile the radial access was the most used and constant for coronary and noncoronary interventions in our center (71%) in this period, the use of brachial access increased (from 4% to 12%) causing the femoral to decrease (from 27% to 16%). We used the brachial approach for diagnostic purposes in 162 patients (19%) and for head to toe endovascular interventions (including angioplasty, stenting, thrombolysis, or as adjunctive access) in 685 patients (81%). For 53 patients (6.2%), this was the only possible access for endovascular intervention. Overall access site-related complications occurred in 25 patients (2.9%), in 19 of them (2.2%) required surgical correction, for brachial artery thrombosis or pseudoaneurysm. The other six were managed conservatively. No permanent neurological deficits of the arm or severe bleeding were observed. Minor complications, mostly hematomas, occurred in 62 patients (7.3%), but they required no further treatment.ConclusionBrachial artery access expands our capability to perform complex procedures by allowing us to reach arterial targets in all territories. Complications of brachial vascular access are gradually decreasing together with the decrease of the crossing profile of the devices used in practice. However, when they occur, they often require surgical treatment. The growing experience of the team not only while obtaining the access but also while achieving adequate hemostasis (“patent hemostasis”) is of great importance for minimizing the complications.