Suspended

NSD5Efficacy and Safety of Intravenous Dextrose 5% vs Normal Saline in Haemodialysis for ESRF Patients - Systolic Blood Pressure Control

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the effectiveness and safety of Intravenous Dextrose 5% compared to Normal Saline in controlling systolic blood pressure in patients undergoing haemodialysis for End Stage Renal Failure (ESRF).

What is being tested

Dextrose 5%

+ normal saline

Drug
Who is being recruted

Urogenital Diseases+10

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 74 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Phase 4
Interventional
Study Start: October 2015
See protocol details

Summary

Principal SponsorPenang Hospital, Malaysia
Study ContactLoke Meng Ong, FRCP
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2015

Actual date on which the first participant was enrolled.

This clinical trial is a comparison study between two solutions used in a procedure called 'wash back' during hemodialysis for patients with end stage renal failure (ESRF). The study aims to find out if a sugar solution called intravenous dextrose 5% is more effective than the standard care solution, normal saline (0.9% sodium chloride), in controlling systolic blood pressure over a 3-month period. This research is important as it could potentially improve the management of blood pressure in patients undergoing regular hemodialysis, addressing a common challenge in ESRF care. During the trial, participants receive either the dextrose solution or normal saline during their dialysis sessions. The main goal is to measure how much the systolic blood pressure reduces after the intervention compared to the baseline. Additionally, the study monitors changes in body weight, thirst level, and body fluid volume. These measurements help evaluate the overall safety and effectiveness of using dextrose solution in the wash back procedure.

Official TitleA 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.
NCT02590081
Principal SponsorPenang Hospital, Malaysia
Study ContactLoke Meng Ong, FRCP
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

434 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 74 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney Failure, ChronicPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

5 inclusion criteria required to participate
Ambulatory, clinically stable maintenance HD patients on a thrice weekly HD regime.
Have regular hemodialysisforat least 6 months or more.
Willing and able to provide written, signed informed consent after the nature of the study has been explained.
Willing and able to comply with all study procedures.
Show More Criteria
14 exclusion criteria prevent from participating
Diabetes mellitus, Malignancy, Pregnancy
Inability or unwillingness to provide written consent.
Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
Simultaneous participation in another clinical study except observational trials
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Dextrose 5% will be used for wash back procedure at the end of hemodiaysis.

Group II

Active Comparator
Normal saline will be used for wash back procedure at the end of hemodiaysis.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Suspended

Hospital Sultanah Bahiyah, Alor Setar

Alor Star, MalaysiaOpen Hospital Sultanah Bahiyah, Alor Setar in Google Maps
Suspended

UKM Medical Centre

Cheras, Malaysia
Suspended

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia
Suspended

UM Medical Centre

Kuala Lumpur, Malaysia
Suspended15 Study Centers