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

Effect of Sodium Concentration of Priming and Rinsing Fluids on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients: a Prospective Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01168947
Enrollment
17
Registered
2010-07-23
Start date
2010-07-31
Completion date
2012-11-30
Last updated
2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Overload and Hypertension in Hemodialysis Patients

Keywords

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

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.

Interventions

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

Sponsors

Renal Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Interdialytic weight gain12 weeks

Secondary

MeasureTime frame
Pre and post dialysis blood pressure levels.12 weeks
Intradialytic events.12 weeks
Thirst levels12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026