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

NCT ID: NCT01168947

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-11-30

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.

Conditions

Fluid Overload and Hypertension in Hemodialysis Patients

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5% dextrose

5% dextrose rinsing fluid

Group Type: EXPERIMENTAL

5% dextrose solution

Intervention Type: OTHER

The extracorporeal circuit of the dialysis machine will be primed and rinsed with a 5% dextrose solution instead of 0.9% saline.

Interventions

5% dextrose solution

The extracorporeal circuit of the dialysis machine will be primed and rinsed with a 5% dextrose solution instead of 0.9% saline.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renal Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Kotanko, MD

Role: PRINCIPAL_INVESTIGATOR

Renal Research Institute

Locations

Yorkville Dialysis Center

New York, New York, United States

Countries

United States

References

Rootjes PA, Penne EL, Ouellet G, Dou Y, Thijssen S, Kotanko P, Raimann JG. Dextrose solution for priming and rinsing the extracorporeal circuit in hemodialysis patients: A prospective pilot study. Int J Artif Organs. 2021 Nov;44(11):906-911. doi: 10.1177/03913988211020023. Epub 2021 May 31.

Reference Type: DERIVED

PMID: 34058888 (View on PubMed)

Other Identifiers

052-10

Identifier Type: -

Identifier Source: org_study_id