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

Penang Hospital, Malaysia434 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

434

Conditions

End-Stage Kidney Disease Hemodialysis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (15)

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

...and 5 more locations

Outcomes

Primary Outcomes

systolic blood pressure control

post intervention systolic blood pressure reduction compared to baseline

Time frame: Time from week 0 until week 12

Secondary Outcomes

Interdialytic weight gain

reduced Interdialytic weight gain in experimental group

Time frame: 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 frame: 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 frame: Time from week 0 until week 12

adverse events

All observed or spontaneously reported adverse events occur during the trial period.

Time frame: Time from week 0 until week 12

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

Overview

Conditions

Interventions

Eligibility

Locations (15)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts