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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.
Age
18 - 74 years
Sex
ALL
Healthy Volunteers
No
Hospital Sultanah Bahiyah, Alor Setar
Alor Star, Kedah, Malaysia
UKM Medical Centre
Cheras, Kuala Lumpur, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
UM Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Tuanku Jaafar
Seremban, Negeri Sembilan, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Hospital Balik Pulau
Balik Pulau, Pulau Pinang, Malaysia
Hospital Bukit Mertajam
Bukit Mertajam, Pulau Pinang, Malaysia
Penang Hospital
George Town, Pulau Pinang, Malaysia
Hospital Kepala Batas
Kepala Batas, Pulau Pinang, Malaysia
Start Date
October 1, 2015
Primary Completion Date
October 1, 2016
Last Updated
October 28, 2015
434
ESTIMATED participants
Dextrose 5%
DRUG
normal saline
DRUG
Lead Sponsor
Penang Hospital, Malaysia
Collaborators
NCT07462741
NCT07179705
Data Source & Attribution
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