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

Hemodialysis Clinical Trial

— NSD5  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02590081
• Other study ID #: NMRR-14-950-20443
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 27, 2015
• Last updated: October 27, 2015
• Start date: October 2015

Study information

• Verified date: October 2015
• Source: Penang Hospital, Malaysia
• Contact: Loke Meng Ong, FRCP
• Phone: +60-04-2225333
• Email: onglokemeng[@]gmail.com
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review BoardMalaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 434
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• End-Stage Kidney Disease
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Dextrose 5%

• normal saline

Locations

Country	Name	City	State
Malaysia	Hospital Sultanah Bahiyah, Alor Setar	Alor Setar	Kedah
Malaysia	Hospital Balik Pulau	Balik Pulau	Penang
Malaysia	Hospital Bukit Mertajam	Bukit Mertajam	Penang
Malaysia	UKM Medical Centre	Cheras	Wilayah persekutuan Kuala lumpur
Malaysia	Penang Hospital	George Town	Penang
Malaysia	Hospital Kepala Batas	Kepala Batas	Penang
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	UM Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan	Pahang
Malaysia	Miri Hospital	Miri	Sarawak
Malaysia	Seberang Jaya Hospital	Seberang Jaya	Penang
Malaysia	Selayang Hospital	Selayang	Selangor
Malaysia	Hospital Serdang	Serdang	Selangor
Malaysia	Hospital Tuanku Jaafar	Seremban	Negeri Sembilan
Malaysia	Hospital Sungai Bakap	Sungai Bakap	Penang

Sponsors (2)

Lead Sponsor	Collaborator
Penang Hospital, Malaysia	Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (2)

Agarwal R. Epidemiology of interdialytic ambulatory hypertension and the role of volume excess. Am J Nephrol. 2011;34(4):381-90. doi: 10.1159/000331067. Epub 2011 Sep 2. — View Citation

Brennan JM, Ronan A, Goonewardena S, Blair JE, Hammes M, Shah D, Vasaiwala S, Kirkpatrick JN, Spencer KT. Handcarried ultrasound measurement of the inferior vena cava for assessment of intravascular volume status in the outpatient hemodialysis clinic. Clin J Am Soc Nephrol. 2006 Jul;1(4):749-53. Epub 2006 May 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic blood pressure control	post intervention systolic blood pressure reduction compared to baseline	Time from week 0 until week 12	No
Secondary	Interdialytic weight gain	reduced Interdialytic weight gain in experimental group	Time from week 0 until week 12	No
Secondary	thirst level	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	No
Secondary	intradialytic event	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	Yes
Secondary	adverse events	All observed or spontaneously reported adverse events occur during the trial period.	Time from week 0 until week 12	Yes