CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVAcombination
Likely dose
Not stated in record
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Search/NCT03232515
NCT03232515N/ACompleted

The Use of Electrical Bioimpedance to Evaluate Dry Weight in Patients With Chronic Renal Failure in Hemodialysis

Universidad de Sonora·interventional·Posted Jul 28, 2017·Updated Nov 29, 2018

In Brief

A clinical study evaluating To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVA for Chronic Renal Failure and 3 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed Summary

INTRODUCTION: Accurate estimation of dry weight (DW) is an important and difficult problem in clinical practice. DW is defined as the lowest weight after hemodialysis (HD) where the patient will not develop symptoms of hypotension and edema, in addition to not using antihypertensives. Achieving a fluid balance benefits the control of blood pressure and reduces cardiovascular risk. In most HD centers, the DW is estimated using a subjective method dependent on the signs and symptoms that the patient presents. Recently, several approaches have been studied to develop a standardized DW evaluation technique. Among these, the analysis of electric bioimpedance vectors (BIVA) has been recognized as a simple and promising method with high reproducibility. OBJECTIVE: To use BIVA to improve dry weight estimation in patients with chronic renal failure undergoing hemodialysis. Methods: This is a non-randomized pre-test / post-test clinical trial, where the universe of patients comes from the hemodialysis unit of the General State Hospital of Sonora. Patients who have limb amputations, pacemakers, metal implants, who are under renal transplant protocol or who have a renal transplant, and presence of infectious foci will be restricted from participating. The diagnosis of DW in the patients will be performed for modification and follow-up. Fluid status will be evaluated using BIVA. Measurements will be made before and after HD in three consecutive weekly periods and one one final assessment at three months. At the beginning of each period, weight, electrolytes, creatinine, total proteins, albumin, pre-albumin, urea and blood pressure will be measured to calculate the Malnutrition Inflammation Score and Bilbrey Index. At the end of the HD protocol of each period, body composition and muscle strength will be evaluated through triceps skinfold, mid-upper arm circumference and dynamometry. The dialysis dose received will be modified according to BIVA. The main variables to be considered will be DW, extracellular water and blood pressure. The duration of the study will be approximately 6 months. In addition, at the end of each measurement, each participant will be given a nutritional recommendation (feeding guide) specific to their energy requirements.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 28, 2017
Enrollment StartAug 7, 2017
Primary CompletionFeb 7, 2018
Study CompletionAug 7, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.9 years ago

Interventions

To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVAcombination

Using the BIVA method, excess fluid will be estimated in patients with chronic renal failure undergoing hemodialysis in order to obtain a better estimate of dry weight and thus improve the quality of life of patients.