Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis Patients
NSD5
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.
1 other identifier
interventional
434
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 27, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedOctober 28, 2015
October 1, 2015
1 year
October 27, 2015
October 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
systolic blood pressure control
post intervention systolic blood pressure reduction compared to baseline
Time from week 0 until week 12
Secondary Outcomes (4)
Interdialytic weight gain
Time from week 0 until week 12
thirst level
Time from week 0 and week 12
intradialytic event
Time from week 0 until week 12
adverse events
Time from week 0 until week 12
Study Arms (2)
Normal saline
ACTIVE COMPARATORNormal saline will be used for wash back procedure at the end of hemodiaysis.
dextrose 5%
EXPERIMENTALDextrose 5% will be used for wash back procedure at the end of hemodiaysis.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penang Hospital, Malaysialead
- Ministry of Health, Malaysiacollaborator
Study Sites (15)
Hospital Sultanah Bahiyah, Alor Setar
Alor Star, Kedah, 05460, Malaysia
UKM Medical Centre
Cheras, Kuala Lumpur, 56000, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
UM Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Hospital Tuanku Jaafar
Seremban, Negeri Sembilan, 70300, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100, Malaysia
Hospital Balik Pulau
Balik Pulau, Pulau Pinang, 11000, Malaysia
Hospital Bukit Mertajam
Bukit Mertajam, Pulau Pinang, 14000, Malaysia
Penang Hospital
George Town, Pulau Pinang, 10990, Malaysia
Hospital Kepala Batas
Kepala Batas, Pulau Pinang, 13200, Malaysia
Seberang Jaya Hospital
Seberang Jaya, Pulau Pinang, 13700, Malaysia
Hospital Sungai Bakap
Sungai Bakap, Pulau Pinang, 14200, Malaysia
Miri Hospital
Miri, Sarawak, 98000, Malaysia
Selayang Hospital
Selayang Baru Utara, Selangor, 68100, Malaysia
Hospital Serdang
Serdang, Selangor, 43400, Malaysia
Related 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.
PMID: 21893975BACKGROUNDBrennan 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. doi: 10.2215/CJN.00310106. Epub 2006 May 24.
PMID: 17699282BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Loke Meng Ong, FRCP
Penang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
October 27, 2015
First Posted
October 28, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2016
Last Updated
October 28, 2015
Record last verified: 2015-10