Effect of Sodium Concentration of Priming and Rinsing Fluids on Weight Gain

Not Applicable

Completed

• Conditions: Fluid Overload and Hypertension in Hemodialysis Patients
• Interventions: Other: 5% dextrose solution

• Registration Number: NCT01168947
• Lead Sponsor: Renal Research Institute

Brief Summary

Sodium loading during hemodialysis treatment is common and may contribute to increased interdialytic weight gain and hypertension. Excessive use of isotonic saline (containing 0.9% sodium chloride) is one of the factors that may cause sodium loading. During each hemodialysis session, approximately 400 mL of isotonic saline fluid, representing 1.4 grams of sodium, is used to prime and rinse the extracorporeal circuit, and is often administered to the patient. Switching to a non sodium-containing priming and rinsing fluid could allow for removal of the equivalent amount of sodium.

Switching to a non sodium-containing solution for the priming and rinsing of the extracorporeal circuit can contribute to increased sodium removal during the dialysis treatment and allow for reduced interdialytic weight gain, reduced thirst, and improved blood pressure control.

Detailed Description

This 12 week study consists of 3 phases:

Phase 1 (4 weeks): Observation only. Standard priming/rinsing procedure with isotonic saline Phase 2 (4 weeks): Intervention. Switch to a 5% dextrose solution for priming/rinsing procedure Phase 3 (4 weeks): Switch back to standard priming/rinsing procedure with isotonic saline During the study, blood pressures will be measured in a standardized manner at 2 week intervals, a thirst questionnaire will be completed at the end of each phase, and interdialytic weight gain, in-center pre/post-HD blood pressure and intradialytic symptoms will be recorded, apart for routinely measured parameters.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-23
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Ambulatory, clinically stable maintenance HD patients on a thrice weekly HD regimen.
• 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.

Exclusion Criteria

• Diabetes mellitus
• Considerable residual renal function (diuresis > 500 mL/day)
• 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
• Expectation that native kidney function will recover
• Impossibility to perform a blood pressure measurement on the upper limb
• Unable to verbally communicate in English
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5% dextrose	5% dextrose solution	5% dextrose rinsing fluid

Primary Outcome Measures

Name	Time	Method
Interdialytic weight gain	12 weeks

Secondary Outcome Measures

Name	Time	Method
Intradialytic events.	12 weeks
Thirst levels	12 weeks
Pre and post dialysis blood pressure levels.	12 weeks

Trial Locations

Locations (1)

Yorkville Dialysis Center; 🇺🇸 New York, New York, United States