NCT05814146 Trial of Variable Dialysate Bicarbonate
| NCT ID | NCT05814146 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Peri-dialytic Cardiac Rhythms |
| Study Type | INTERVENTIONAL |
| Enrollment | 141 participants |
| Start Date | 2023-08-24 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 141 participants in total. It began in 2023-08-24 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Katherine S Ravi, MD, MPH
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT05814146 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Peri-dialytic Cardiac Rhythms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05814146 currently recruiting?
Yes, NCT05814146 is actively recruiting participants. Contact the research team at ksravi@bwh.harvard.edu for enrollment information.
Where is the NCT05814146 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05814146 clinical trial?
NCT05814146 is sponsored by Brigham and Women's Hospital. The principal investigator is Katherine S Ravi, MD, MPH at Brigham and Women's Hospital. The trial plans to enroll 141 participants.