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

NCT01168947 | Completed

• 1 other identifier: 052-10
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Overload and Hypertension in Hemodialysis Patients

Keywords

sodium; hypertension; fluid overload; hemodialysis; dialysate; interdialytic weight gain; intradialytic hypotension

Outcome Measures

Primary Outcomes (1)

• Interdialytic weight gain

  12 weeks

Secondary Outcomes (3)

• Pre and post dialysis blood pressure levels.

  12 weeks

• Intradialytic events.

  12 weeks

• Thirst levels

  12 weeks

Study Arms (1)

5% dextrose

EXPERIMENTAL

5% dextrose rinsing fluid

Other: 5% dextrose solution

Interventions

5% dextrose solution OTHER

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

5% dextrose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Renal Research Institute: lead

Study Sites (1)

Yorkville Dialysis Center

New York, New York, 10128, United States

Location

Related Publications (1)

• 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.

  PMID: 34058888 DERIVED

MeSH Terms

Conditions

Edema; Hypertension

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Peter Kotanko, MD

  Renal Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 23, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

US (1)