Recruiting

Variable Dialysate Bicarbonate

Sponsor:

Brigham and Women's Hospital

Code:

NCT05814146

Conditions

Peri-dialytic Cardiac Rhythms

Intradialytic Hypotension

Electrolyte Changes

pH Changes

Adverse Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dialysate bicarbonate concentration

Dialysate bicarbonate concentration - telemetry monitoring

Study Details

Brief summary:

QTc prolongation and premature ventricular contractions (PVCs) are common in hemodialysis (HD) patients and are associated with sudden cardiac death.

It is known that higher dialysate bicarbonate is associated with more QTc prolongation during HD sessions.

This study aims to assess the effects of lower (30 mEq/L) versus higher (35 mEq/L) dialysate bicarbonate in adult maintenance HD patients admitted to the hospital.

The investigators will randomly assign subjects to lower versus higher dialysate bicarbonate concentrations during their hospital stay for up to a maximum of six HD sessions or until their hospital discharge.

Conditions

Peri-dialytic Cardiac Rhythms

Intradialytic Hypotension

Electrolyte Changes

pH Changes

Adverse Symptoms

Study ID

NCT05814146

Start date

Aug 24, 2023

Status verified date

Oct, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • prevalent end-stage renal disease, on maintenance HD > 90 days
  • age ≥ 18 years old
  • thrice weekly HD

Exclusion Criteria:

  • hemoglobin < 8.0 g/dL
  • pregnancy
  • any physical, mental or medical condition which limited the ability to provide written informed consent

Study Design

Enrollment

141 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lower dialysate bicarbonate

A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L).

active comparator: Higher dialysate bicarbonate

A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L).

Interventions

Dialysate bicarbonate concentration

Assess how a lower dialysate bicarbonate affects:

  • QTc duration during and between hemodialysis sessions
  • PVC burden during and between hemodialysis sessions
  • Clinically significant arrhythmia during and between hemodialysis sessions
  • Intradialytic hypotension
  • Adverse symptoms during hemodialysis sessions

Dialysate bicarbonate concentration - telemetry monitoring

Patients will be monitored with telemetry on both arms of the trial.

Primary outcome measure

  • QTc prolongation [ Time Frame: During hemodialysis procedure (during dialysate administration) ]

Central Contacts and Locations

Central contacts

Katherine S Ravi, MD, MPH

(617) 732-6383ksravi@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Katherine S Ravi, MD, MPH

617-732-6383

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.