Comparing lower and higher bicarbonate levels in dialysis patients
Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 141 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05814146 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with end-stage renal disease on maintenance hemodialysis for more than 90 days.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.