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ClinicalTrials.gov ID

NCT02590081

Lead Sponsor

Penang Hospital, MalaysiaOTHER_GOV

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

434Estimated

Last Update Posted

Oct 28, 2015Estimated

Start Date

Oct 2015

Primary Completion Date

Oct 2016Estimated

Official Title

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.

Brief 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.

• End-Stage Kidney Disease
• Hemodialysis

• Dextrose 5%
• normal saline

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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.
• Age ≥18 years; Age < 75 years old

Exclusion Criteria:

• 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
• Any psychological condition which could interfere with the patient's ability to comply with the study protocol
• Inability to perform a blood pressure measurement on the upper limb
• Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period.
• Life expectancy < 6 months
• Recent acute myocardial infarction, congestive cardiac failure, stroke, angina or ICU admission within last 6 months,
• Planned to migrate/move out of the city
• Alcohol abuse/ drug abuse within last 6 months
• Missed > 2 hemodialysis sessions over 1 month
• Requiring non- cuff catheter for hemodialysis
• Admitted for major infection within the last one month

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Penang Hospital, MalaysiaOTHER_GOV

Collaborators

Ministry of Health, MalaysiaOTHER_GOV

sookun_73@yahoo.com+60-0379492497

mohdramliseman9@gmail.com+60-09-5572222

onglokemeng@gmail.com00 604 2225333 ext. 5767

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bak.leong@gmail.com+60-03-89475555