Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:
• prevalent end-stage renal disease, on maintenance HD \> 90 days
• age ≥ 18 years old
• thrice weekly HD
Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Katherine S Ravi, MD, MPH
ksravi@bwh.harvard.edu
(617) 732-6383
Time Frame
Start Date: 2023-08-24
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 141
Treatments
Experimental: Lower dialysate bicarbonate
A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L).
Active_comparator: Higher dialysate bicarbonate
A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L).
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital