Comparing lower and higher bicarbonate levels in dialysis patients
Official title: Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients
Run by Brigham and Women's Hospital · NCT05814146 · Data updated 2026-11-12
This study tests if using lower or higher levels of bicarbonate during dialysis can affect heart rhythms and other symptoms in adult patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 141 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | August 24, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT05814146 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with end-stage renal disease on maintenance hemodialysis for more than 90 days.
✕Probably not a fit
Patients with hemoglobin levels below 8.0 g/dL, those who are pregnant, or individuals unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effects of different concentrations of dialysate bicarbonate on cardiac rhythms and other symptoms in adult patients undergoing hemodialysis. Participants will be randomly assigned to receive either a lower concentration (30 mEq/L) or a higher concentration (35 mEq/L) of bicarbonate during their dialysis sessions in the hospital. The study aims to determine how these varying levels impact QTc prolongation, premature ventricular contractions, and overall patient safety during dialysis. Patients will be monitored for up to six dialysis sessions or until discharge.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiac safety and reduced adverse symptoms for patients undergoing hemodialysis.
How similar studies have gone: While the specific approach of varying bicarbonate levels is being assessed in this study, previous research has indicated that electrolyte management during dialysis can significantly impact patient outcomes, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Katherine S Ravi, MD, MPH — Brigham and Women's Hospital
- Study coordinator: Katherine S Ravi, MD, MPH
- Email: ksravi@bwh.harvard.edu
- Phone: (617) 732-6383
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.