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.
Overview
- Phase
- Phase 4
- Intervention
- normal saline
- Conditions
- End-Stage Kidney Disease
- Sponsor
- Penang Hospital, Malaysia
- Enrollment
- 434
- Locations
- 15
- Primary Endpoint
- systolic blood pressure control
- Last Updated
- 10 years ago
Overview
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.
Investigators
Dr.Ong Loke Meng
doctor
Penang Hospital, Malaysia
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
Arms & Interventions
Normal saline
Normal saline will be used for wash back procedure at the end of hemodiaysis.
Intervention: normal saline
dextrose 5%
Dextrose 5% will be used for wash back procedure at the end of hemodiaysis.
Intervention: Dextrose 5%
Outcomes
Primary Outcomes
systolic blood pressure control
Time Frame: Time from week 0 until week 12
post intervention systolic blood pressure reduction compared to baseline
Secondary Outcomes
- 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)