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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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End-Stage Kidney Disease, Hemodialysis

Intervention / Treatment
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* Drug: Dextrose 5%
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure control | 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 | reduced Interdialytic weight gain in experimental group | Time from week 0 until week 12 | 
| 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 | 
| 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 | 
| adverse events | All observed or spontaneously reported adverse events occur during the trial period. | Time from week 0 until week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Normal saline, Destrose 5%, Blood pressure, Interdialytic weight gain, thirst level, End Stage Renal Failure