NCT02590081

Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis Patients

A Prospective Randomized, Double-Blind Parallel Group Trial To Assess The Efficacy And Safety Of Intravenous Dextrose 5% Solution Compare With Normal Saline (Standard Care) In Rinsing During Haemodialysis In Subjects With End Stage Renal Failure (ESRF) With Respect To Systolic Blood Pressure Control Over 3 Months Period.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 434 (estimated)
• Sponsor: Penang Hospital, Malaysia · Other Government
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, double-blind, parallel group trial to assess the efficacy and safety of intravenous dextrose 5% solution compare with normal saline (standard care) in wash back procedure during haemodialysis in patients with end stage renal failure (ESRF) with respect to systolic blood pressure control over 3 months period. The primary objective is to establish efficacy of 5% dextrose solution compared with normal saline (0.9% sodium chloride solution) with respect to systolic blood pressure control in subjects with end stage renal failure (ESRF) on regular hemodialysis. Secondary objectives include monitoring the change in body weight, thirst level and body fluid volume.

Conditions

• End-Stage Kidney Disease
• Hemodialysis

Interventions

Type	Name	Description
DRUG	Dextrose 5%
DRUG	normal saline

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-10-01
• First posted: 2015-10-28
• Last updated: 2015-10-28

Locations

15 sites across 1 country: Malaysia