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Peritoneal Dialysis clinical trials

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NCT ID: NCT04185168 Completed - Peritoneal Dialysis Clinical Trials

Isoflavones and Peritoneal Dialysis

Start date: November 16, 2019
Phase: N/A
Study type: Interventional

The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic will randomly assign to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and serum concentrations of fructoseamine, carboxymethyl lysine, pentosidine, glucose will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing

NCT ID: NCT04076930 Active, not recruiting - Peritoneal Dialysis Clinical Trials

Effects of Renin-Angiotensin System Inhibitors in Peritoneal Dialysis Patients

Start date: August 31, 2019
Phase:
Study type: Observational

Among antihypertensive medications, RAS inhibitor classes, namely angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) have the most prospective data on mortality and cardiovascular outcomes in specific high-risk populations with mild to moderate chronic kidney disease (CKD). Whereas, long-term data on the risks and benefits of ACEI/ARB usage in end-stage kidney disease (ESKD) patients undergoing peritoneal dialysis (PD) are limited. Recently, increasing clinical studies suggested that ACEI/ARB had a beneficial effect on intermediate outcomes, including short-term blood pressure variability, left ventricular hypertrophy, and may have an important role in the peritoneum and the kidney protection. Subsequently, treatment with ACEI/ARB has been recommended by the International Society for Peritoneal Dialysis for PD patients with significant residual kidney function (RKF). Although existing reviews demonstrated that ACEI/ARB significantly has benefit in preserving RKF in PD patients, evidence regarding the relative efficacy on mortality, cardiovascular outcomes, and adverse events is lacking. Given that there exist few controlled trials of the effectiveness of ACEI/ARB in PD patients, we intend to perform a retrospective cohort study to assess the association between the use of ACEI/ARB and the risk of long-term mortality, cardiovascular outcomes, and adverse events in terms of hyperkalemia. A retrospective cohort of Thai PD patients will be constructed by using the local joint registry data of adult PD patients from five centers in Thailand between 2006 to 2017 and followed to December 2018. We will link the following health datasets: (i) the electronic health records, contains outpatient and inpatient data; (ii) the Support System Pharmacy Dispensing extract, an administrative database which covers pharmacy dispensing; (iii) the PD Patient Care Database, which provides patient-level detail on sociodemographic and clinical characteristics as well as long-term PD care data; and (iv) the Laboratory Support System extract, which includes claims and routine laboratory results. The exposure of interest in this cohort will be the use of ACEI/ARB within a 90-day after the date of PD initiation. Outcomes of interest will include all-cause mortality, cardiovascular mortality, a composite endpoint of cardiovascular events, and adverse events in terms of hyperkalemia.

NCT ID: NCT04064086 Recruiting - Clinical trials for Chronic Kidney Disease

Trial to Evaluate and Assess the Effect of Comprehensive Pre-ESKD Education on Home Dialysis Use in Veterans

TEACH-VET
Start date: March 25, 2020
Phase: N/A
Study type: Interventional

This study is intended to correct an important systemic deficit in the care of chronic kidney disease (CKD), VHA's fourth most common healthcare condition with high mortality and healthcare burden. Currently, many Veterans with CKD have poor awareness of their condition. This leads to suboptimal care. The investigators anticipate that the proposed comprehensive pre-end stage renal disease (ESRD) education (CPE) will enhance Veterans' CKD knowledge and their confidence in making an informed selection of an appropriate dialysis modality, and lead to an increase in the use of home dialysis (HoD) - an evidence-based, yet underutilized dialysis modality. Further, this study will allow us to examine whether such Veteran-informed dialysis choice can improve Veteran and health services outcomes. If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.

NCT ID: NCT04006093 Completed - Peritoneal Dialysis Clinical Trials

Apixaban in Subjects With Peritoneal Dialysis

ApiDP
Start date: December 8, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the pharmacokinetics of a single oral dose of apixaban (5mg) in participants with dialysis peritoneal versus participants with normal renal function.

NCT ID: NCT03980795 Completed - Clinical trials for Kidney Failure, Chronic

Exercise in Peritoneal Dialysis Patients (PDEX)

PDEX
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Patients with end-stage kidney disease (ESKD) receiving peritoneal dialysis (PD) are physically inactive, resulting in poor physical function and reduced quality of life. The aim of this pilot trial was to test the study feasibility of a combined resistance and cardiovascular exercise program (recruitment and retention rates) and report adherence and adverse events. The intervention (I) group received monthly exercise physiologist consultations, exercise prescription (resistance and aerobic exercise program using exercise bands) and weekly phone calls over 12 weeks. Control (C) group received normal care. Feasibility outcomes were exercise adherence rates and adverse events. Secondary measures included physical function measures and patient-reported outcome measures (PROMs)

NCT ID: NCT03953950 Not yet recruiting - Clinical trials for End Stage Renal Disease

Effect of Add-on Spironolactone to Losartan Versus Losartan Alone on Peritoneal Membrane Among Peritoneal Dialysis Patients

ESCAPE-PD
Start date: October 2019
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT03900819 Completed - Peritoneal Dialysis Clinical Trials

Evaluation of Dexterity in Prevalent Peritoneal Dialysis Patients

DEXTER
Start date: January 1, 2019
Phase:
Study type: Observational

The objective of the study is to measure the manual dexterity of patients treated by peritoneal dialysis - transversal study

NCT ID: NCT03864120 Completed - Peritoneal Dialysis Clinical Trials

Understand the Difference Between Clinical Measured UF and Real UF.

Start date: June 15, 2019
Phase:
Study type: Observational

The importance of ultrafiltration (UF) and fluid status in peritoneal dialysis has been increasingly aware of over the last two decades. There is growing body of observational evidence showing that low UF is related to unfavorable outcome especially in anuric patients. The other side of the problem of UF is excessive fluid removal could volume deplete patients and result in loss of residual renal function and overexposing the membrane to glucose unnecessarily. UF is a double-edged sword. The correct measure of UF is the bottom line of talking about target. Measuring UF is supposed to be simple and straight forward. The most common way of measuring UF in clinical practice was to weight the effluent bag and minus the manufacture announced fill volume. Until about 10 years ago, the society first aware that the measurement error in such way is not acceptable. Overfil (the actual volume of dialysate fill in the bag is more than announced) problem was raised from then. However, there are several other problems around this issue. Firstly, when the product has just been produced overfill is different between manufactory. Secondly, the overfill volume does change over transportation and storage. But it is not clear how big the change is. Thirdly, most of the clinics weight the dialysate effluent rather than measure the volume in CAPD, although the specific gravity of dialysate is clearly not going to be 1g/ml. Taking the fact measuring weight is much easier than measuring volume in CAPD, the question behind is to understand how big the difference is and consequently whether it is acceptable. All the patients enrolled in the study would be asked to collect all dialysate effluent of the day of their routine peritoneal dialysis adequacy study and bring to the hospital. The exact weight of the bag for PET test (2.5% glucose concentration and dwell time of 4 hour) before and after the dwell and volume measured of the effluent. The dialysate electrolyte, glucose, protein and creatinine level would also be measured.

NCT ID: NCT03801044 Completed - Peritoneal Dialysis Clinical Trials

Lung Ultrasound in PD Patients

LUSiPD
Start date: May 1, 2018
Phase:
Study type: Observational

Although many alternative methods are present, maintaining ideal volume status in peritoneal dialysis (PD) patients still rely on clinical evaluation due to lack of an evidence based method. Lung ultrasound (LUS) is a new method for evaluation of hidden congestion in this group. LUS findings and its relationship with other volumetric methods are investigated in this study. LUS was performed to all peritoneal dialysis patients and compared with symptoms of hypervolemia, physical examination, vascular endothelial growth factor-C (VEGF-C) and N-terminal pro-brain natriuretic peptide levels, chest radiography, echocardiography, bioelectrical impedance analysis.

NCT ID: NCT03677063 Completed - Peritoneal Dialysis Clinical Trials

Usefulness of Sterile Adhesive Dressing at the Exit-site of Peritoneal Dialysis Catheter

PANCADIPE
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Infection of peritoneal dialysis fluid is a major complication in patients treated with peritoneal dialysis (PD). The aim of catheter emergence care is to reduce bacterial contamination of the peritoneum. The recommendations of the International Society of Peritoneal Dialysis do not provide information on the frequency of care delivery or the usefulness of a sterile adhesive dressing. Thus each treatment center applies a protocol of its own. Dressing is common practice although its safety and interest are not demonstrated. The usefulness of dressing is still to be demonstrated. On the other hand, the efficacy of the application in prevention of a cream of mupirocin at emergence on the reduction of the risk of infection with staphylococcus aureus (SA), the most frequent germ found in peritonitis, has been demonstrated. A Spanish study showed that during a peritoneal infection at SA the site most frequently colonized by a similar strain of SA was the emergence of the catheter. It can be considered that an infection of the dialysis liquid in PD is not only related to the quality of emergency care but also to manipulations during exchanges. Given the number of patients involved in PD in France, it is difficult to obtain sufficient power to formally demonstrate the non-inferiority of the absence of dressing. Therefore, the investigators propose a descriptive, exploratory study of events that may occur in PD when a dressing is not applied. This is a step prior to performing a multicenter randomized comparative study that will aim to show the non-inferiority of the absence of dressing compared to the application of a dressing on the incidence of fluid infection. peritoneal dialysis.