scholarly journals Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): Study Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Karin Bergling ◽  
Javier de Arteaga ◽  
Fabián Ledesma ◽  
Carl Mikael Öberg
Keyword(s):  
Peritoneal Dialysis ◽  
Clinical Investigation ◽  
Controlled Trial ◽  
Glucose Absorption ◽  
Treatment Session ◽  
Crossover Fashion ◽  
Diabetic Patients ◽  
Automated Peritoneal Dialysis ◽  
Open Label ◽  
Before And After

Abstract Background: It has been estimated that automated peritoneal dialysis (APD) is currently the fastest growing renal replacement therapy in the world. However, in light of the growing number of diabetic patients on peritoneal dialysis (PD), the unwanted glucose absorption during APD remains problematic. Recent results, using an extended 3-pore model of APD, indicated that large reductions in glucose absorption are possible by using optimized bi-modal treatment regimens, having “UF cycles” using a higher glucose concentration and “Clearance cycles” using a low concentration or, preferentially, no glucose. The present study is designed to test the theoretical prediction of a lower glucose absorption using these novel regimes. Methods: This study is a randomized single-center, open-label, prospective study. Prevalent PD patients between 18 to 75 years old without known catheter problems or recent peritonitis are eligible for inclusion. Patients are allocated to a first treatment session of either Standard APD (6 × 2 L 1.36% over 9 hours) or Optimized APD (7 × 2 L 2.27% + 5 × 2 L 0.1% over 8 hours). A second treatment session using the other treatment will be performed in a crossover fashion. Samples of the dialysis fluid will be taken before and after the treatment and the volume of the dialysate before and after the treatment will be carefully assessed. The primary endpoint is difference in glucose absorption between the Optimized and Standard treatment. Secondary endpoints are ultrafiltration, sodium removal, Kt/V urea and Kt/V Creatinine. The study will be closed when a total of 20 patients have successfully completed the interventions or terminated according to interim analysis. A Monte Carlo power analysis shows that the study has 80% power to detect a difference of 10 g (in line with that of theoretical results) in glucose absorption between the two treatments in 10 patients. Discussion: The present study is the first clinical investigation of optimized bi-modal treatments proposed by recent theoretical studies.

scholarly journals Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): Study Protocol for a Randomized Controlled Crossover Trial

2020 ◽  
Author(s):  
Karin Bergling ◽  
Javier de Arteaga ◽  
Fabián Ledesma ◽  
Carl Mikael Öberg
Keyword(s):  
Peritoneal Dialysis ◽  
Clinical Investigation ◽  
Glucose Absorption ◽  
Treatment Session ◽  
Crossover Fashion ◽  
Diabetic Patients ◽  
Automated Peritoneal Dialysis ◽  
Open Label ◽  
Sodium Removal ◽  
Before And After

Abstract Background: It has been estimated that automated peritoneal dialysis (APD) is currently the fastest growing renal replacement therapy in the world. However, in light of the growing number of diabetic patients on peritoneal dialysis (PD), the unwanted glucose absorption during APD remains problematic. Recent results, using an extended 3-pore model of APD, indicated that large reductions in glucose absorption are possible by using optimized bi-modal treatment regimens, having “UF cycles” using a higher glucose concentration and “Clearance cycles” using a low concentration or, preferentially, no glucose. The present study is designed to test the theoretical prediction of a lower glucose absorption using these novel regimes.Methods: This study is a randomized single-center, open-label, prospective study. Prevalent PD patients between 18 to 75 years old without known catheter problems or recent peritonitis are eligible for inclusion. Patients are allocated to a first treatment session of either Standard APD (6 × 2 L 1.36% over 9 hours) or Optimized APD (7 × 2 L 2.27% + 5 × 2 L 0.1% over 8 hours). A second treatment session using the other treatment will be performed in a crossover fashion. Samples of the dialysis fluid will be taken before and after the treatment and the volume of the dialysate before and after the treatment will be carefully assessed. The primary endpoint is difference in glucose absorption between the Optimized and Standard treatment. Secondary endpoints are ultrafiltration, sodium removal, Kt/V urea and Kt/V Creatinine. The study will be closed when a total of 20 patients have successfully completed the interventions or terminated according to interim analysis. A Monte Carlo power analysis shows that the study has 80% power to detect a difference of 10 g (in line with that of theoretical results) in glucose absorption between the two treatments in 10 patients.Discussion: The present study is the first clinical investigation of optimized bi-modal treatments proposed by recent theoretical studies.Trial registration: ClinicalTrials.gov identifier: NCT04017572. Registration date: 12/07/2019, retrospectively registered. URL: https://clinicaltrials.gov/ct2/show/NCT04017572

scholarly journals Icodextrin reduces insulin resistance in non-diabetic patients undergoing automated peritoneal dialysis: results of a randomized controlled trial (STARCH)

2015 ◽  
Vol 30 (11) ◽  
pp. 1905-1911 ◽  
Author(s):  
Thyago Proença de Moraes ◽  
Maria Cláudia Cruz Andreoli ◽  
Maria Eugênia Canziani ◽  
Dirceu Reis da Silva ◽  
Jacqueline Costa Teixeira Caramori ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Controlled Trial ◽  
Diabetic Patients ◽  
Automated Peritoneal Dialysis ◽  
Randomized Controlled

Icodextrin Improves Metabolic and Fluid Management in High and High-Average Transport Diabetic Patients

2009 ◽  
Vol 29 (4) ◽  
pp. 422-432 ◽  
Author(s):  
Ramón Paniagua ◽  
María-de-Jesús Ventura ◽  
Marcela Ávila-Díaz ◽  
Alejandra Cisneros ◽  
Marlén Vicenté–Martínez ◽  
...  
Keyword(s):  
Metabolic Control ◽  
Controlled Trial ◽  
Fluid Management ◽  
Extracellular Fluid ◽  
Glucose Absorption ◽  
Serum Glucose ◽  
Diabetic Patients ◽  
Open Label ◽  
Fluid Control ◽  
Time Changes

Background Icodextrin-based solutions (ICO) have clinical and theoretical advantages over glucose-based solutions (GLU) in fluid and metabolic management of diabetic peritoneal dialysis (PD) patients; however, these advantages have not yet been tested in a randomized fashion. Objective To analyze the effects of ICO on metabolic and fluid control in high and high-average transport diabetic patients on continuous ambulatory PD (CAPD). Patients and Methods A 12-month, multicenter, open-label, randomized controlled trial was conducted to compare ICO ( n = 30) versus GLU ( n = 29) in diabetic CAPD patients with high-average and high peritoneal transport characteristics. The basic daily schedule was 3 × 2 L GLU (1.5%) and either 1 × 2 L ICO (7.5%) or 1 × 2 L GLU (2.5%) for the long-dwell exchange, with substitution of 2.5% or 4.25% for 1.5% GLU being allowed when clinically necessary. Variables related to metabolic and fluid control were measured each month. Results Groups were similar at baseline in all measured variables. More than 66% of the patients using GLU, but only 9% using ICO, needed prescriptions of higher glucose concentration solutions. Ultrafiltration (UF) was higher (198 ± 101 mL/day, p < 0.05) in the ICO group than in the GLU group over time. Changes from baseline were more pronounced in the ICO group than in the GLU group for extracellular fluid volume (0.23 ± 1.38 vs –1.0 ± 1.48 L, p < 0.01) and blood pressure (systolic 1.5 ± 24.0 vs –10.4 ± 30.0 mmHg, p < 0.01; diastolic 1.5 ± 13.5 vs –6.2 ± 14.2 mmHg, p < 0.01). Compared to baseline, patients in the ICO group had better metabolic control than those in the GLU group: glucose absorption was more reduced (–17 ± 44 vs –64 ± 35 g/day) as were insulin needs (3.6 ± 3.4 vs – 9.1 ± 4.7 U/day, p < 0.01), fasting serum glucose (8.3 ± 36.5 vs –37 ± 25.8 mg/dL, p < 0.01), triglycerides (54.5 ± 31.9 vs –54.7 ± 39.9 mg/dL, p < 0.01), and glycated hemoglobin (0.79% ± 0.79% vs –0.98% ± 0.51%, p < 0.01). Patients in the ICO group had fewer adverse events related to fluid and glucose control than patients in the GLU group. Conclusion Icodextrin represents a significant advantage in the management of high transport diabetic patients on PD, improving peritoneal UF and fluid control and reducing the burden of glucose overexposure, thereby facilitating metabolic control.

scholarly journals The effect of rTMS in the management of pain associated with CRPS

2020 ◽  
Vol 11 (1) ◽  
pp. 363-370
Author(s):  
Min Cheol Chang ◽  
Sang Gyu Kwak ◽  
Donghwi Park
Keyword(s):  
Repetitive Transcranial Magnetic Stimulation ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Pain Syndrome ◽  
Treatment Session ◽  
Cochrane Library ◽  
Exclusion Criteria ◽  
Analgesic Effects ◽  
Randomized Controlled ◽  
Before And After

AbstractBackgroundTherapeutic management of pain in patients with complex regional pain syndrome (CRPS) is challenging. Repetitive transcranial magnetic stimulation (rTMS) has analgesic effects on several types of pain. However, its effect on CRPS has not been elucidated clearly. Therefore, we conducted a meta-analysis of the available clinical studies on rTMS treatment in patients with CRPS.Materials and methodsA comprehensive literature search was conducted using the PubMed, EMBASE, Cochrane Library, and SCOPUS databases. We included studies published up to February 09, 2020, that fulfilled our inclusion and exclusion criteria. Data regarding measurement of pain using the visual analog scale before and after rTMS treatment were collected to perform the meta-analysis. The meta-analysis was performed using Comprehensive Meta-analysis Version 2.ResultsA total of three studies (one randomized controlled trial and two prospective observational studies) involving 41 patients were included in this meta-analysis. No significant reduction in pain was observed immediately after one rTMS treatment session or immediately after the entire schedule of rTMS treatment sessions (5 or 10 sessions; P > 0.05). However, pain significantly reduced 1 week after the entire schedule of rTMS sessions (P < 0.001).ConclusionrTMS appears to have a functional analgesic effect in patients with CRPS.

Peritoneal Solute Clearances after four Years of Continuous Ambulatory Peritoneal Dialysis (CAPD)

1989 ◽  
Vol 9 (1) ◽  
pp. 75-78 ◽  
Author(s):  
Min Sun Park ◽  
Jean Lee ◽  
Moon Sung Lee ◽  
Seung Ho Baick ◽  
Seung Duk Hwang ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Glucose Absorption ◽  
Peritoneal Membrane ◽  
Vasoactive Agents ◽  
Membrane Function ◽  
Dialysis Solution ◽  
Before And After ◽  
Dialysate Volume

In order to evaluate peritoneal membrane function and responsiveness of peritoneal microcirculation to vasoactive agents in long-term continuous ambulatory peritoneal dialysis (CAPD) patients, we studied peritoneal clearances of urea (Curea) and creatinine (Ccr), protein concentrations in drained dialysate (D PC), peritoneal glucose absorption (% GA), and drained dialysate volume ( VD) before and after nitroprusside (NP) addition to dialysis solution in 17 long-term CAPD patients (mean duration of CAPD: 52 months) and the results were compared to those of 18 patients who were just trained for CAPD (mean duration: 0.6 month). There were no differences in the control (without NP) Curea, Ccr, D PC, %GA, and VD between the new and long-term CAPD patients. Curea, Ccr, and D PC increased significantly with NP in both new and long-term patients. Curea and Ccr with NP were not different between the new and long-term patients but D PC with NP was significantly lower in the long-term CAPD patients. The results of this study suggest that peritoneal solute clearances and the responsiveness of peritoneal microcirculation to NP remain unchanged after four years of CAPD, despite recurrent episodes of peritonitis.

scholarly journals Antidopaminergic treatment is associated with reduced chorea and irritability but impaired cognition in Huntington’s disease (Enroll-HD)

2020 ◽  
Vol 91 (6) ◽  
pp. 622-630
Author(s):  
Kate L Harris ◽  
Wei-Li Kuan ◽  
Sarah L Mason ◽  
Roger A Barker
Keyword(s):  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Case Reports ◽  
Controlled Trial ◽  
Rate Of Change ◽  
Control Group ◽  
Open Label ◽  
Double Blind ◽  
Before And After ◽  
Rate Of Decline

ObjectivesAlterations in dopamine neurotransmission underlie some of the clinical features of Huntington’s disease (HD) and as such are a target for therapeutic intervention, especially for the treatment of chorea and some behavioural problems. However, justification for such an intervention is mainly based on case reports and small open label studies and the effects these drugs have on cognition in HD remain unclear.MethodsIn this study, we used the Enroll-HD observational database to assess the effects of antidopaminergic medication on motor, psychiatric and cognitive decline, over a 3-year period. We first looked at the annual rate of decline of a group of HD patients taking antidopaminergic medication (n=466) compared with an untreated matched group (n=466). The groups were matched on specified clinical variables using propensity score matching. Next, we studied a separate group of HD patients who were prescribed such medications part way through the study (n=90) and compared their rate of change before and after the drugs were introduced and compared this to a matched control group.ResultsWe found that HD patients taking antidopaminergic medication had a slower progression in chorea and irritability compared with those not taking such medications. However, this same group of patients also displayed significantly greater rate of decline in a range of cognitive tasks.ConclusionIn conclusion we found that antidopaminergic treatment is associated with improvements in the choreic movements and irritability of HD but worsens cognition. However, further research is required to prospectively investigate this and whether these are causally linked, ideally in a double-blind placebo-controlled trial.

The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients

2009 ◽  
Vol 29 (5) ◽  
pp. 562-567 ◽  
Author(s):  
Daniel O. Young ◽  
Steven C. Cheng ◽  
James A. Delmez ◽  
Daniel W. Coyne
Keyword(s):  
Peritoneal Dialysis ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Treatment Options ◽  
Study Drug ◽  
Phosphate Binders ◽  
Open Label ◽  
Double Blind ◽  
Phosphorus Levels ◽  
Plasma Phosphorus

Background Hyperphosphatemia remains a significant problem for patients requiring dialysis and is associated with increased mortality. Current treatment options include dietary restriction, dialysis, and phosphate binders. Treatment using the latter is frequently limited by cost, tolerability, and calcium loading. One open-label trial found niacinamide to be effective at decreasing serum phosphorus values in hemodialysis patients. Niacinamide may effectively reduce phosphorus levels in peritoneal dialysis (PD) patients already receiving standard phosphorus-lowering therapies. Methods An 8 week, randomized, double blind, placebo-controlled trial to evaluate the effectiveness of niacinamide to reduce plasma phosphorus levels in PD patients. Patients had to demonstrate a baseline phosphorus value > 4.9 mg/dL. Patients were randomized to niacinamide or placebo and prescribed 250 mg twice daily, with titration to 750 mg twice daily, as long as safety parameters were not violated. Phosphate binders, active vitamin D, and cinacalcet were kept constant during the study. The primary end point was change in plasma phosphorus. Secondary end points included changes in lipid parameters. Results 15 patients started on the study drug (8 niacinamide, 7 placebo) and 7 in each arm had at least one on-study phosphorus measurement. The niacinamide treatment group experienced an average 0.7 ± 0.9 mg/dL decrease in plasma phosphorus and the placebo-treated group experienced an average 0.4 ± 0.8 mg/dL increase. The treatment effect difference (1.1 mg/dL) was significant ( p = 0.037). No significant changes in high- or low-density lipoproteins or triglycerides were demonstrated. Two of the 8 patients randomized to the niacinamide treatment arm had to withdraw from the study due to drug-related adverse effects. Adverse effects may limit the use of niacinamide in PD patients. Conclusion Niacinamide, when added to standard phosphorus-lowering therapies, resulted in a modest yet statistically significant reduction in plasma phosphorus levels at 8 weeks. [ClinicalTrials.gov number NCT00508885 (ClinicalTrials.gov)]

scholarly journals Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024589
Author(s):  
Wen Yao Mak ◽  
Loke Meng Ong ◽  
Bak Leong Goh ◽  
Sunita Bavanandan ◽  
Lily Mushahar ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Open Label ◽  
Randomised Controlled ◽  
End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

scholarly journals Randomized, Controlled Trial of Glucose-Sparing Peritoneal Dialysis in Diabetic Patients

2013 ◽  
Vol 24 (11) ◽  
pp. 1889-1900 ◽  
Author(s):  
Philip K.T. Li ◽  
Bruce F. Culleton ◽  
Amaury Ariza ◽  
Jun-Young Do ◽  
David W. Johnson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Controlled Trial ◽  
Diabetic Patients ◽  
Randomized Controlled
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