View clinical trials related to End Stage Renal Disease.
Filter by:The ESCAPE-PD (Effects of add-on SpironolaCtone to losartan versus Alone on Peritoneal mEmbrane among continuous ambulatory Peritoneal Dialysis patients) study is a randomized, open-label, single center, active-controlled clinical trial. Adults end-stage kidney disease patients 18 years or older undergoing continuous ambulatory peritoneal dialysis (CAPD) will be enrolled. A total 84 CAPD will be randomly assigned to either the combination of spironolactone and losartan (experimental arm) or losartan alone (control arm). The primary outcomes are the difference in peritoneal dialysate effluent cancer antigen-125 (CA-125) and peritoneal equilibration test (PET) indices (dialysate-to-plasma creatinine ratio, 4-hour ultrafiltration volume, and the concentration of glucose present in the solution at the start of the test). Secondary outcome measures include laboratory and mechanistic outcome measures, nutrition outcomes, health-related quality of life, physical function, clinical events, and safety profiles. Results will be disseminated to suggest a strategy to prevent the peritoneal membrane function among CAPD patients through peer-reviewed publications along with scientific meetings.
Open label, randomized, cross-over clinical study comparing the acute effect of high versus low protein meals during dialysis on intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices on maintenance hemodialysis patients.
A majority of patients with end-stage renal disease (ESRD) on in-center hemodialysis (HD) require several hours to recover from fatigue after an HD session. Evidence for practical interventions to improve this recovery time from conventional in-center HD is lacking. This study investigates the effects of reducing HD blood flow rates on patients' self-reported post-dialysis fatigue.
The objective of this study is to determine the effect of music therapy during dialysis on: depression, anxiety, quality of life, blood pressure, heart rate, medication compliance, compliance with dialysis treatment, number of hospitalizations, pain level, and energy level.
Malnutrition in hemodialysis patients is frequent and it is associated with a reduction in muscular mass, strength, functional capacity and quality of life, with an increment in inflammatory and oxidative markers, and with a dysregulation of circulating miRNAs and its target genes. Animal and human studies have reported that some dietary components (macronutrients, micronutrients and other bioactive substances) might restore these altered features. Thus, we hypothesized that the intake of an oral nutritional supplement (ONS) specifically developed for malnourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants, carnitine, and with or without probiotics) vs. individualized diet recommendations might: - Improve nutritional status (visceral proteins, muscular mass), functional capacity and quality of life. - Reduce inflammatory and oxidative markers, and modulate the circulating levels of some miRNAs and the expression of its target genes on cells. miRNAs may be useful biomarkers to check the response to a nutritional intervention in malnourished hemodialysis patients. The present study is a randomized, multicenter, parallel-group trial with 3 groups, open to the intake of ONS or individualized diet recommendations, but double-blind to the intake of probiotics. Inclusion criteria comprised adult subjects (>18 y/o) undergoing hemodialysis more than 6 months previous at inclusion and at least one of these caloric malnutrition criteria: a) involuntary weight loss >5% in 3 months or >10% in 6 months; b) serum albumin < 3.5 g/dl or prealbumin <28 mg/dl; c) body mass index (BMI) < 23 kg/m2; d) muscular mass loss >5% in 3 months or >10% in 6 months. The study duration is 6 months, and comprises 4 visits (screening, basal, 3 months and 6 months). A nutritional examination that included anthropometric measurements, handgrip strength measured by a hand dynamometer, body composition assessed by bioelectrical impedance analysis (BIA) and a 5 days dietary record; quality of life evaluation by the "12-item short form health survey"; the presence of symptoms of depression and anxiety (Hospital Anxiety and Depression Scale); assessment of functional status by the "Barthel" test, the "Short Physical Performance Battery" and the "International Physical Activity Questionnaire"; and blood and stool samples will be obtained for each participant in each study visit (except screening visit).
This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft. The STARgraft has been demonstrated in preclinical studies to have improved resistance to the common failure mode of venous anastomosis stenosis. Performance of the STARgraft AV will be compared against control implants of commercially available standard ePTFE grafts approved for the same use. The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to: 1. Demonstrate improved primary patency of the investigational STARgraft AV compared to the ePTFE controls over a period of 6 months, with extended results to 1 year. 2. Verify safety of the STARgraft AV multilayer construction in extended vascular access use. It is intended to enroll 25 subjects each for the investigational devices and the controls respectively (50 total) with randomized device allocation at subject presentation for implant surgery.
After providing informed consent, patients will be randomized to either the intervention treatment ("EvoCit procedure") or the control treatment ("EvoHep procedure"). After randomization, each study arm consists of four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol. After the last dialysis treatment of the fourth treatment week and after a long interdialytic interval, patients will crossover to the alternative hemodialysis procedure. After crossover, the study will be completed with, again, four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol.
This study will investigate the effect of pre-operative exercise on hemodynamics in the fistula artery and vein, Pre and Post Arteriovenous Fistula Formation as well as the suitability of Cannulation of Arteriovenous Fistula at 12 weeks Post Surgery. This is a randomised control study with 20 patients each in the Control arm (Group A) or the Exercise arm (Group B). The subjects will be randomised into 1:1 into one of the two groups. The patients will have an ultrasound doppler vein mapping done prior surgery and the necessary follow up visits.
The study aims to evaluate the appropriateness of initiating oral anticoagulation for stroke risk reduction in dialysis populations with atrial fibrillation. Specifically, the study will assess the overall safety, tolerability, and efficacy of initiating treatment with Warfarin in patients with end-stage renal disease on dialysis and atrial fibrillation.
The incidence and prevalence of chronic kidney disease are increasing worldwide, as is the number of patients progressing to End-Stage Renal Disease (ESRD). China has experienced an increased accessibility and affordability of dialysis treatment, which in turn has brought about an increase in the number of patients receiving Renal Replacement Therapy (RRT).Without RRT, either in the form of maintenance dialysis or transplantation, ESRD is fatal. The scope of the trial is to observe the performance of Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line versus AK 200 Ultra S, extracorporeal circulation conduct of blood purification apparatus and Ultra Steriset as the comparator devices in treatment of patients using hemodialysis (HD) or hemodiafiltration (HDF) for ESRD.