Clinical Trials Logo
  1. Home
  2. Peritoneal Dialysis
  3. NCT01045980

Effect of Bio-impedance Analysis and Vitamin D vs Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: A Randomized Controlled Trial (FLUID Study) — FLUID  

Peritoneal Dialysis Clinical Trial

Official title:
The Effect of Bio-impedance Analysis and Vitamin D Versus Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: a Randomized Controlled Trial

Clinical Trial Summary

The main purpose of this study is to compare the effects of using bio-impedance analysis to guide management of fluid status versus routine clinical care on heart structure. In addition, Vitamin D is being assessed to determine its effect on heart structure.

Clinical Trial Description

Patients on peritoneal dialysis are frequently hypervolemic which is associated with deleterious changes in left ventricular (LV) architecture including increased LV mass. In dialysis patients, increased LV mass is associated with death. Recent randomized trials have demonstrated that increasing small solute clearance is not associated with improved outcomes - hence an increased interest in the management of volume control in ESRD patients. Bioimpedance analysis is inexpensive, safe and easy to use and appears to be more useful than other techniques to assess volume status in dialysis patients. In addition, dialysis patients are vitamin D deficient and this is also associated with an increased LV mass and its inherent complications.

This study will evaluate the use of bioimpedance analysis versus usual care to assess and manage volume status and the use of vitamin D versus placebo in peritoneal dialysis patients and its effect on LV mass as measured by cardiac MRI. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01045980
Study type Interventional
Source St. Joseph's Healthcare Hamilton
Contact Dr. Azim S Gangji, MD MSc FRCPC
Phone 9055221155
Email gangji@mcmaster.ca
Status Recruiting
Phase Phase 2
Start date August 2010
Completion date August 2015
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04925674 - Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis. Phase 1
Terminated NCT03438877 - Intensive Versus Regular Dosage For PD In AKI. N/A
Completed NCT05149508 - Intraperitoneal Pressure Measurements in Children
Not yet recruiting NCT04900610 - The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis N/A
Withdrawn NCT03019159 - Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis N/A
Recruiting NCT01195519 - The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis N/A
Recruiting NCT06351007 - Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK) N/A
Not yet recruiting NCT04628117 - Effect of Oral Nutritional Supplementation on Oxidative Stress in Protein-energy Wasting Patients With Peritoneal Dialysis N/A
Recruiting NCT05449067 - CAPD Versus APD in Nondiabetic Peritoneal Dialysis Patients N/A
Not yet recruiting NCT03953950 - Effect of Add-on Spironolactone to Losartan Versus Losartan Alone on Peritoneal Membrane Among Peritoneal Dialysis Patients Phase 4
Completed NCT02128347 - Effectiveness of an Online Portal for Delivery of Care to Home Dialysis Patients N/A
Completed NCT01209273 - Comparison of Quality of Life on Automated Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis N/A
Completed NCT00734552 - Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients N/A
Not yet recruiting NCT06096558 - The Effects of Melatonin on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients N/A
Completed NCT04413266 - Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis N/A
Not yet recruiting NCT06060951 - Relating Abdominal Complications With Peritoneal Pressure Estimation and Reporting
Completed NCT03980795 - Exercise in Peritoneal Dialysis Patients (PDEX) N/A
Not yet recruiting NCT02270229 - Evaluation of the Peritoneal Dialysis Program in a Hospital in Chinandega, Nicaragua. N/A
Completed NCT02347592 - Peritoneal Dialysis Catheter Function N/A
Withdrawn NCT00397358 - Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients Phase 4