Actively Recruiting
Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients
Led by Brigham and Women's Hospital · Updated on 2025-11-24
141
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of different dialysate bicarbonate levels on heart rhythm abnormalities in adults undergoing maintenance hemodialysis (HD) who are hospitalized. The study focuses on QTc prolongation and premature ventricular contractions (PVCs), which are common in HD patients and linked to sudden cardiac death. The aim is to compare lower versus higher dialysate bicarbonate concentrations to understand their impact on cardiac risks during HD sessions. Participants will be randomly assigned to receive either a lower dialysate bicarbonate concentration of 30 mEq/L or a higher concentration of 35 mEq/L during their hospital stay. The treatment will be administered during up to six HD sessions or until hospital discharge. Both groups will be monitored closely with telemetry to track heart rhythms and any arrhythmias. Throughout the study, patients will undergo continuous heart monitoring during and between HD sessions to measure QTc duration, PVC burden, clinically significant arrhythmias, intradialytic hypotension, and adverse symptoms. The main outcome is the QTc prolongation observed during the dialysis procedure. The study involves a randomized, double-blind design and will last for the duration of the hospital stay, with assessments focused on cardiac rhythm changes related to dialysate bicarbonate levels.
CONDITIONS
Brief Title
Trial of Variable Dialysate Bicarbonate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- On maintenance hemodialysis for more than 90 days
- Receiving hemodialysis three times per week
You will not qualify if you...
- Hemoglobin level less than 8.0 g/dL
- Pregnancy
- Any physical, mental, or medical condition that limits the ability to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable based on participant's ongoing hemodialysis schedule during the trial period
Participants receive hemodialysis three times per week with either a lower or higher dialysate bicarbonate concentration to assess effects on heart rhythm and blood pressure during and between sessions.
Hemodialysis sessions three times per week with telemetry monitoring during sessions
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
K
Katherine S Ravi, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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