Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis Patients (NSD5)

Penang Hospital, Malaysia

Status and phase: Unknown; Phase 4

Conditions: Hemodialysis; End-Stage Kidney Disease

Treatments: Drug: Dextrose 5%; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02590081

NMRR-14-950-20443

Details and patient eligibility

About

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.

Enrollment: 434 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

434 participants in 2 patient groups

Normal saline

Active Comparator group

Description:

Normal saline will be used for wash back procedure at the end of hemodiaysis.

Treatment:

Drug: normal saline

dextrose 5%

Experimental group

Description:

Dextrose 5% will be used for wash back procedure at the end of hemodiaysis.

Treatment:

Drug: Dextrose 5%