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Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients

NCT ID: NCT00724633

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-01

Study Completion Date

2017-07-31

Brief Summary

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Patients currently receiving hemodialysis will be randomized to receive 1 of 3 dialysate sodium prescriptions. The effects on blood pressure, interdialytic weight gain, thirst, and intradialytic symptoms will be assessed.

Detailed Description

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Conditions

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Hemodialysis

Keywords

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dialysate sodium hemodialysis blood pressure thirst intradialytic symptoms interdialytic weight gain extracellular fluid balance mechanisms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

standard dialysate Na 140 mEq/L

Group Type OTHER

Lowering the dialysate sodium

Intervention Type OTHER

Please see above

2

dialysate sodium equal to patient's predialysis serum Na

Group Type ACTIVE_COMPARATOR

Lowering the dialysate sodium

Intervention Type OTHER

Please see above

3

dialysate sodium lower than patient's predialysis plasma sodium

Group Type ACTIVE_COMPARATOR

Lowering the dialysate sodium

Intervention Type OTHER

Please see above

Interventions

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Lowering the dialysate sodium

Please see above

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients on 3 times weekly hemodialysis of at least 3 months
* elevated average ambulatory blood pressures
* current dialysate sodium prescription 140mEq/L
* average pre-dialysis serum sodium \<140mEq/L

Exclusion Criteria

* frequent intradialytic hypotension
* estimated life expectancy \<1 year
* non-adherence to dialysis prescription
* pregnancy
* inability or unwillingness to complete study measures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rita Suri, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

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London Health Sciences Center

London, Ontario, Canada

Site Status

Countries

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Canada

References

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Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.

Reference Type DERIVED
PMID: 39498822 (View on PubMed)

Other Identifiers

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15153

Identifier Type: -

Identifier Source: secondary_id

R-08-252

Identifier Type: -

Identifier Source: org_study_id