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Peritoneal Dialysis clinical trials

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NCT ID: NCT06368713 Recruiting - Quality of Life Clinical Trials

Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients.

NCT ID: NCT06351007 Recruiting - Clinical trials for Chronic Kidney Disease

Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK)

EPAK
Start date: September 19, 2023
Phase: N/A
Study type: Interventional

A fundamental strategy to improve adherence to nutritional treatment in patients with chronic kidney disease is the implementation of educational programs. The aim of this study is to evaluate the effect of a multidisciplinary educational program on dietary adherence, nutritional knowledge, nutritional status, metabolic control and quality of life in patients with chronic kidney disease, predialysis, peritoneal dialysis and hemodialysis. A randomized clinical trial will be carried out, in which patients who meet the inclusion criteria will be randomly assigned to three possible groups: predialysis educational intervention, dialysis educational intervention and control group. At the initial visit, the nutritional status will be evaluated by means of anthropometric parameters, screening and dynamometry, the biochemical parameters of interest will be extracted from the clinical record, nutritional knowledge and quality of life will be evaluated, and the diet will be explained. In the second visit, adherence to the diet will be evaluated and the food registry will be carried out. In the intervention groups, the educational program will begin with a duration of five months. Patients will come twice a month to the hospital to participate in the educational sessions and attend group psychology sessions. After completion of the educational program, the same measurements as at the beginning of the study will be carried out in the three groups.

NCT ID: NCT06330194 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease

Start date: April 18, 2024
Phase: N/A
Study type: Interventional

The goal of this this randomized, clinical trial is to test an automated insulin delivery system (AID) in people with type 1 or type 2 diabetes who are on hemodialysis, peritoneal dialysis, or have advanced chronic kidney disease (CKD). The main objective is: • To test if the AID is superior in regulating blood sugar levels compared with usual care in patients with advanced renal disease Secondary objectives are: • To evaluate the impact on life quality, incidence of low blood sugar, and if the treatment is feasible in this population Participants will be randomized to receive either eight weeks with the AID System (780G from Medtronic) or eight weeks of Control (usual care) with cross over at the end of the first eight weeks. Researchers will compare blood sugar levels between the AID group and the Control group to determine if the AID system is superior in regulating blood sugar levels.

NCT ID: NCT05721404 Recruiting - Peritoneal Dialysis Clinical Trials

Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal Dialysis

Start date: May 24, 2023
Phase: Phase 4
Study type: Interventional

We hypothesize incremental peritoneal dialysis (incremental PD) protocol with icodextrin solution will help patients to achieve adequate ultrafiltration and adequate dialysis with less glucose exposure by manipulating a low frequency of exchanges, therefore prolong the time from incremental protocol to full dose protocol (Full dose dialysis is defined as a dialysis dose of more than 8 L (4 exchanges of 2 L) per day). The goal of this clinical trial is to investigate the effect of icodextrin postponing the shift of low dose to full dose dialysis in the first year of incremental peritoneal dialysis. The main questions are: - The effect of icodextrin on the shift of low dose to full dose dialysis in the first year in patients on incremental peritoneal dialysis. - The effect of icodextrin on clinical outcomes in patients on incremental peritoneal dialysis, such as the first episode of peritonitis, the incidence of anuria, the first incidence of hospitalization, technical failure, all cause mortality, cardiovascular disease free survival and the quality of life. Participants will be 1:1 randomized to the ICO (icodextrin) arm and CON (control) arm. Both arms patients will be followed every 2 months for fluid status by bioimpedance analysis. An extracellular water /total body water (ECW/TBW) ≥ 0.40 or edema is defined as overhydration (OH). The OH patients in the ICO arm will be prescribed icodextrin (Extraneal) for long night dwell to improve fluid overload till their re-measurement of ECW/TBW < 0.40 or edema disappeared. The OH patients in the CON arm will be prescribed hypertonic Dextrose solution for long night dwell to improve fluid overload till their ECW/TBW < 0.40 or edema disappeared. Researchers will compare the time of transferring from low dose PD to full dose and the clinical outcomes in the first year between the patients in ICO and CON groups to see the effect of icodextrin on the shift of low dose to full dose dialysis and clinical outcomes in the first year in patients on incremental peritoneal dialysis. Successful completion of the study will advance our strategy of incremental PD and help to prolong the shift from incremental to full dose dialysis, and offer new opportunities for the development of an effective and economical therapy for PD patients with residual kidney function (RKF)

NCT ID: NCT05449067 Recruiting - Peritoneal Dialysis Clinical Trials

CAPD Versus APD in Nondiabetic Peritoneal Dialysis Patients

Start date: October 28, 2022
Phase: N/A
Study type: Interventional

Background: Continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD) are two important PD modalities. To date, only three small sample randomized control trials(RCTs) comparing CAPD and APD have been conducted but yield inconsistent results. Objective: Investigators plan to initiate a multicenter, prospective, randomized cross-over study to compare the quality of life and dialysis adequacy in non-diabetic PD patients. Hypothesis: Patients' quality of life and dialysis adequacy on APD is no worse than on CAPD. Methods: This study plans to recruit 268 non-diabetic patients on maintenance peritoneal dialysis. Patients will randomly be assigned into groups A and B in a 1:1 ratio: group A receives APD from week 1 to 12 and changes to CAPD from week 13 to 24; group B receives CAPD from week 1 to 12 and changes to APD from week 13 to 24. Outcomes were evaluated at week 12 and week 24.

NCT ID: NCT04730830 Recruiting - Peritoneal Dialysis Clinical Trials

Occurrence of Emerging Infections After Placement of a Peritoneal Dialysis CatHeter

SINEPHILE
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Peritoneal dialysis, which appeared at the end of the 1970s, quickly proved its worth both in terms of its effectiveness and of its ease of compliance, which guarantees an improved quality of life. To date there are different modes of application of this technique: Continuous Ambulatory Peritoneal Dialysis, and Automated Peritoneal Dialysis. Whatever the technique used, the placement of a dressing covering the exit site of the catheter is necessary just after the placement of the PD catheter and this so that the site of emergence is kept dry until healing (in general 2 to 4 weeks). Once the emergence site has healed, the technique can be started. Discharge site infections are a major predisposing factor for the development of peritonitis. Numerous studies in different parts of the world have shown that the rates of PD-related infections have steadily declined over the past 10 to 20 years. Several recommendations for the prevention and treatment of emergence site infections have been published by the International Peritoneal Dialysis Society. Several studies nonetheless call into question the recommendations by showing that catheter infection is not linked to the number of risk factors present at the time of catheter insertion, nor to the prescription of antibiotic prophylaxis, nor to the the experience of the caregiver, the antiseptic used or the early dressing change. In addition, only antibiotic prophylaxis at catheter placement is strongly recommended. Regarding the other measures, their relevance is not always demonstrated and their application varies considerably from one center to another. In addition, many authors have sought to establish a definition of catheter infections in order to allow an optimal assessment of their frequency. However, these definitions are not universal and have certain limitations. The objective of this work is on the one hand to better characterize the incidence of infections at the site of emergence in peritoneal dialysis, and on the other hand, in the absence of a definition established according to the recommendations, to use the score de Schaeffer, is in particular the value of this score which would make it possible to define more precisely the presence of an infection.

NCT ID: NCT04603014 Recruiting - Hemodialysis Clinical Trials

Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients

IPUF-HD
Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

Sodium accumulates in the tissues of patients with kidney disease and impairs survival. Three-times weekly, standard hemodialysis alone cannot remove excess sodium efficiently. A sample of 10 chronic hemodialysis patients will undergo a 5-week, pilot, interventional study to test the efficacy of additional sodium removal in-between hemodialysis sessions, twice per week, for three weeks. Tissue sodium removal will be achieved with peritoneal dialysis after the surgical insertion of a peritoneal dialysis catheter. Tissue sodium removal will be assessed at the beginning and at the end of the study with sodium magnetic resonance imaging of a peripheral limb (leg). Patients will also undergo monitoring for symptoms and blood pressure throughout the study to assess the safety of this procedure.

NCT ID: NCT04238338 Recruiting - Inflammation Clinical Trials

Association of MLR With Risk of Death and Cardiovascular Events in PD Patients

Start date: June 1, 2020
Phase:
Study type: Observational

The current incidence of chronic kidney disease (CKD) in China is approximately 10.8%, with approximately 119 million patients. Among them, patients with end-stage renal disease (ESRD) are about 200-250 cases per million population. At present, the main renal replacement therapy is: hemodialysis (HD) or peritoneal dialysis (PD). Compared with HD, PD is easy to operate, better preserves residual renal function, has early survival advantages, and is more cost-effective. Despite this, the prognosis of PD patients is still not ideal, and cardiovascular disease (CVD) remains the leading cause of death in PD patients. Persistent inflammatory states are critical in the pathogenesis of CVD such as atherosclerosis and vascular calcification, and lead to protein energy expenditure and premature death outcomes in patients with CKD. Therefore, screening for markers that predict the risk of CVD in dialysis patients is essential. Some novel inflammatory markers have been shown to have diagnostic and prognostic value in ESRD patients in terms of inflammation, malnutrition, cardiovascular calcification, all-cause, and risk of CVD death. Among them, blood cell related parameters such as neutrophil / lymphocyte ratio (NLR) and monocyte / lymphocyte ratio (MLR)can reflect both inflammation and immune deficiency. NLR, MLR has been proposed as a new inflammatory biomarker and a potential predictor of cardiovascular risk. Studies have reported that MLR is associated with cardiovascular death and all-cause death risk in hemodialysis patients, and is superior to NLR. However, the relationship between MLR and the prognosis of patients with peritoneal dialysis is rarely reported. Therefore, in this study, we aimed to evaluate the association of MLR with risk of death and cardiovascular events in PD patients.

NCT ID: NCT04225416 Recruiting - Hemodialysis Clinical Trials

Perceptions of Illness Severity, Treatment Goals and Life Expectancy

ePISTLE
Start date: November 16, 2018
Phase:
Study type: Observational

This study is exploring symptom burden, health experiences and expectations of treatment and survival of seriously ill dialysis patients and their physicians.

NCT ID: NCT04197674 Recruiting - Hemodialysis Clinical Trials

China Q Cohort Study

Start date: January 21, 2020
Phase:
Study type: Observational

The burden of end-stage kidney disease (ESKD) is increasing worldwide. Although kidney transplantation is the most cost-effective renal replacement therapy, dialysis is still the main way to treat ESRD patients due to the limited kidney donor, with approximately 89% of such dialysis patients receive hemodialysis (HD) and the remainder receive peritoneal dialysis (PD). This distribution of dialysis modality, however, varies widely by health jurisdiction. For instance, more than 97% of dialysis patients are treated with HD in Japan, but more than 50% treated with PD in Mexico. Evidence comparing the two modalities suggests that mortality risks may be comparable, but all evidence come from observational study and there is no randomized controlled trial to compare patient survival between PD and HD due to patients enrollment issue.More importantly, for most health care systems, such as United States, United Kingdom, Australia, Indonesia and China, PD is less expensive than HD. It is possible, then, that a greater global utilization of PD might improve access to renal replacement therapy in less advanced economies. The investigators have conducted a prospective, randomized, parallel, open-label, multi-center, non-inferiority trial to evaluate health-related quality of life (HRQoL) with PD versus conventional in-center HD in incident ESKD patients. A total of 1082 ESKD patients were randomly assigned to PD or conventional in-center HD, and 235 patients enrolled in stage 1 with complete measures of the "Burden of Kidney Disease" at both baseline and 48 weeks and 668 patients enrolled in stage 2 were included in analysis. However, this trial was designed to evaluate quality of life between PD and HD and all patients were follow-up 48 weeks. Therefore, in this observational cohort study, the investigators will perform extended follow-up for participants including in analysis . Our primary objective is to evaluate the association of dialysis modality (PD and HD) with all-cause mortality in ESKD patients. The investigators also explore the impact of PD and HD on major cardiovascular event composite (MACE), a composite outcome of MACE and all-cause death, hospitalized myocardial infarction, hospitalized stroke and hospitalized heart failure, healthy utility, dialysis cost, activity of daily living, and changes of RRF, hemoglobin, and other biochemical parameters.