Trial of Variable Dialysate Bicarbonate

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 1, 2026 → Dec 31, 2026
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Record History

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  1. Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital Show 4 more changesShow less
    • Primary completion pushed from Sep 1, 2026 to Dec 31, 2026
    • Study completion pushed from Oct 1, 2026 to Feb 1, 2027
    • Eligibility criteria expanded, about 6 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv4
  3. Phase: Phase 4 to Not applicablev3 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary completion date: Nov 2026 to Sep 1, 2026
    • Study completion date: Dec 2026 to Oct 1, 2026
    • Start date changed from estimate of Aug 2023 to Aug 24, 2023
  4. Start date: May 2023 to Aug 2023v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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 Details
NCT Number NCT05814146
Lead Sponsor Brigham and Women's Hospital
Conditions
(from sponsor)		 Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension, Electrolyte Changes, pH Changes, Adverse Symptoms
Enrollment 141 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov