Clinical trial NCT01168947: Effect of Sodium Concentration of Priming and Rinsing Fluids on Weight Gain
Official title: Effect of Sodium Concentration of Priming and Rinsing Fluids on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Overload and Hypertension in Hemodialysis Patients
Keywords: sodium
hypertension
fluid overload
hemodialysis
dialysate
interdialytic weight gain
intradialytic hypotension
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Interdialytic weight gain
timeFrame: 12 weeks
Secondary outcomes:
measure: Pre and post dialysis blood pressure levels.
timeFrame: 12 weeks
measure: Intradialytic events.
timeFrame: 12 weeks
measure: Thirst levels
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Yorkville Dialysis Center
state: New York
Study officials:
affiliation: Renal Research Institute
name: Peter Kotanko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.