Dialysate Sodium Lowering Trial

NCT ID: NCT03144817

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-26
• Study Completion Date: 2019-04-02

Brief Summary

This is a pilot randomized clinical trial in which patients treated with 3X per weekly conventional hemodialysis will be treated to a dialysate sodium 135 mEq/L vs. 138 mEq/L and followed for safety and tolerability, effects on BP and volume.

Detailed Description

This is a pilot randomized clinical trial in which hypertensive hemodialysis patients will be randomized to a low dialysate sodium (Na) of 135 mEq/L or a standard dialysate Na of 138 mEq/L. Patients will be randomized 2:1 to the low arm. Dialysate Na will be lowered 1 mEq/L every 2 weeks, as tolerated. Tolerance will be assessed by symptoms, intradialytic hypotension (IDH) episodes (systolic BP <90 or intervention for symptoms or BP drop during dialysis), achievement of dry weight. The trial will last for 6 to 12 months, for an individual, depending on when they entered the trial. The primary outcome is feasibility and safety of using the lower dialysate sodium which is assessed by symptoms during or immediately after dialysis, intradialytic hypotension episodes and the frequency of emergency room visits and hospitalizations. Several secondary outcomes will be measured including blood pressure prior to dialysis and at home, change in plasma Na over time, dry weight, post-dialysis weight, interdialytic weight change, symptoms of thirst and dry mouth, self-reported dialysis recovery time, relative blood volume change during a single treatment (via 'Critline') and, in patients without an implanted electronic device, extraceullular fluid volume (via bioimpedance).

Conditions

Hemodialysis Complication; Fluid Overload; Dialysis Disequilibrium; Intra-dialytic Hypotension; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Intervention group will dialyze with dialysate Na 135 mEq/L.

Group Type: EXPERIMENTAL

Dialysate Sodium Lowering

Intervention Type: OTHER

Dialysate sodium is lowered until nadir sodium level is reached. Participant dialyzes at this sodium level until end of follow-up.

Interventions

Dialysate Sodium Lowering

Dialysate sodium is lowered until nadir sodium level is reached. Participant dialyzes at this sodium level until end of follow-up.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age >18 years
• Patients undergoing thrice weekly in-center conventional HD
• At least 90 days since start of hemodialysis
• Absence of pulmonary edema / signs of fluid overload on physical exam
• Currently dialyzing at a DNa >=137 mEq/L
• Single session Kt/V >=1.3 each month for the past 2 months
• Hypertensive, defined by a pre-dialysis BP of >140/90 or treatment with 1 or more antihypertensive agents
• No more than 1 skipped treatment and no more than 1 session per month shortened by >10 min
• Life expectancy >12 months
• Able to provide Informed Consent
• Speaks and understands English

Exclusion Criteria

• Prone to IDH, defined as IDH occurring in >10% of treatments in the past 3 months. IDH will be defined as symptoms (e.g. cramps, dizziness, loss of consciousness) and/or intra- or post-dialytic systolic BP <90 mm Hg and/or use of intervention(s) (UF goal lowered, treatment stopped early, or saline given) because of IDH
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dialysis Clinic, Inc.

INDUSTRY

Sponsor Role: collaborator

InBody

UNKNOWN

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana Miskulin, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

DCI Boston

Boston, Massachusetts, United States

Countries

United States

References

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

12393

Identifier Type: -

Identifier Source: org_study_id