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

Primary Purpose

Fluid Overload and Hypertension in Hemodialysis Patients

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

5% dextrose solution

About this trial

This is an interventional treatment trial for Fluid Overload and Hypertension in Hemodialysis Patients focused on measuring sodium, hypertension, fluid overload, hemodialysis, dialysate, interdialytic weight gain, intradialytic hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Yorkville Dialysis Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

5% dextrose

Arm Description

5% dextrose rinsing fluid

Outcomes

Primary Outcome Measures

Interdialytic weight gain

Secondary Outcome Measures

Pre and post dialysis blood pressure levels.

Intradialytic events.

Thirst levels

Full Information

NCT ID

NCT01168947

First Posted

July 22, 2010

Last Updated

April 10, 2017

Sponsor

Renal Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01168947

Brief Title

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

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Renal Research Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fluid Overload and Hypertension in Hemodialysis Patients

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

5% dextrose

Arm Type

Experimental

Arm Description

5% dextrose rinsing fluid

Intervention Type

Other

Intervention Name(s)

5% dextrose solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Interdialytic weight gain

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Pre and post dialysis blood pressure levels.

Time Frame

12 weeks

Title

Intradialytic events.

Time Frame

12 weeks

Title

Thirst levels

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Kotanko, MD

Organizational Affiliation

Renal Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yorkville Dialysis Center

City

New York

State/Province

New York

ZIP/Postal Code

10128

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34058888

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.

Results Reference

derived

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

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