Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis Patients (NSD5)

October 27, 2015 updated by: Dr.Ong Loke Meng, Penang Hospital, Malaysia

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

434

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Kedah
      • Alor Setar, Kedah, Malaysia, 05460
        • Hospital Sultanah Bahiyah, Alor Setar
        • Contact:
    • Negeri Sembilan
      • Seremban, Negeri Sembilan, Malaysia, 70300
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan
        • Contact:
    • Penang
      • Balik Pulau, Penang, Malaysia, 11000
        • Hospital Balik Pulau
        • Contact:
          • Loke Meng Ong
      • Bukit Mertajam, Penang, Malaysia, 14000
        • Hospital Bukit Mertajam
        • Contact:
          • Anita Bhajan
      • George Town, Penang, Malaysia, 10990
        • Penang Hospital
        • Contact:
      • Kepala Batas, Penang, Malaysia, 13200
        • Hospital Kepala Batas
        • Contact:
          • Anita Bhajan
      • Seberang Jaya, Penang, Malaysia, 13700
      • Sungai Bakap, Penang, Malaysia, 14200
        • Hospital Sungai Bakap
        • Contact:
          • Anita Bhajan
    • Sarawak
      • Miri, Sarawak, Malaysia, 98000
        • Miri Hospital
        • Contact:
    • Selangor
      • Selayang, Selangor, Malaysia, 68100
        • Selayang Hospital
        • Contact:
      • Serdang, Selangor, Malaysia, 43400
        • Hospital Serdang
        • Contact:
    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
        • Contact:
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
        • UM Medical Centre
        • Contact:
    • Wilayah persekutuan Kuala lumpur
      • Cheras, Wilayah persekutuan Kuala lumpur, Malaysia, 56000
        • UKM Medical Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal saline
Normal saline will be used for wash back procedure at the end of hemodiaysis.
Drug: normal saline
Experimental: dextrose 5%
Dextrose 5% will be used for wash back procedure at the end of hemodiaysis.
Drug: Dextrose 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
systolic blood pressure control
Time Frame: Time from week 0 until week 12
post intervention systolic blood pressure reduction compared to baseline
Time from week 0 until week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interdialytic weight gain
Time Frame: Time from week 0 until week 12
reduced Interdialytic weight gain in experimental group
Time from week 0 until week 12
thirst level
Time Frame: Time from week 0 and week 12
Dialysis thirst inventory questionnaire to be administer by patient at baseline (week 0) and end of trial (week 12)
Time from week 0 and week 12
intradialytic event
Time Frame: Time from week 0 until week 12
Any incident occuring during hemodialysis treatment which needed medical intervention. The event are chills and rigor, chest pain, giddiness, cramps, vomiting, blood loss and hypotension.
Time from week 0 until week 12
adverse events
Time Frame: Time from week 0 until week 12
All observed or spontaneously reported adverse events occur during the trial period.
Time from week 0 until week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penang Hospital, Malaysia

Collaborators

Ministry of Health, Malaysia

Investigators

  • Principal Investigator: Loke Meng Ong, FRCP, Penang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR-14-950-20443

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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