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

Renal Research Institute

Status: Completed

Conditions: Fluid Overload and Hypertension in Hemodialysis Patients

Treatments: Other: 5% dextrose solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01168947

052-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

5% dextrose

Experimental group

Description:

5% dextrose rinsing fluid

Treatment:

Other: 5% dextrose solution