NCT05814146

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Aug 2023Oct 2026

First Submitted

Initial submission to the registry

March 20, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 24, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

March 20, 2023

Last Update Submit

November 19, 2025

Conditions

Peri-dialytic Cardiac RhythmsIntradialytic HypotensionElectrolyte ChangespH ChangesAdverse Symptoms

Outcome Measures

Primary Outcomes (1)

  • QTc prolongation

    QTc prolongation, calculated as post-HD (just as HD finishing, generally 4 hours from start of HD session) minus pre-HD QTc duration, will be obtained via Holter monitoring.

    During hemodialysis procedure (during dialysate administration)

Other Outcomes (7)

  • PVC frequency

    PVCs/hour will be recorded during HD sessions and for ~44-68 hours from the end of the hemodialysis session until the subsequent hemodialysis session.

  • Clinically significant arrhythmia

    Clinically significant arrhythmia will be assessed during hemodialysis sessions and in the subsequent inter-hemodialysis period (until the subsequent hemodialysis session, up to 68 hours).

  • Intradialytic hypotension

    Blood pressures will be measured every 15 minutes during HD sessions.

  • +4 more other outcomes

Study Arms (2)

Lower dialysate bicarbonate

EXPERIMENTAL

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

Drug: Dialysate bicarbonate concentrationDevice: Dialysate bicarbonate concentration - telemetry monitoring

Higher dialysate bicarbonate

ACTIVE COMPARATOR

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

Drug: Dialysate bicarbonate concentrationDevice: Dialysate bicarbonate concentration - telemetry monitoring

Interventions

Dialysate bicarbonate concentrationDRUG

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

Higher dialysate bicarbonateLower dialysate bicarbonate
Dialysate bicarbonate concentration - telemetry monitoringDEVICE

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

Higher dialysate bicarbonateLower dialysate bicarbonate

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

  • Katherine S Ravi, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine S Ravi, MD, MPH

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor Harvard Medical School / Associate Physician Renal Division

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 14, 2023

Study Start

August 24, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)