Clinical trial Recruiting at 1 site Interventional Ages 18 to 120

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 typeInterventional
Ages18 Years to 120 Years
SexAll
Enrollment141 (estimated)
SponsorBrigham and Women's Hospital
Academic / other
Locations1 site (Boston, Massachusetts)
StatusRecruiting
StartedAugust 24, 2023
Main results expectedDecember 31, 2026
Study endsFebruary 1, 2027
Registry record updatedOctober 13, 2026
Trial IDNCT05814146 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.