Trial of Variable Dialysate Bicarbonate

Recruiting now · Not applicable

Conditions studied: Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension, Electrolyte Changes, pH Changes, Adverse Symptoms

In brief

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.

Key facts

Study ID

NCT05814146

Run by

Brigham and Women's Hospital

People needed

141

Starts

2023-08-24

Expected to finish

2026-10-01

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• prevalent end-stage renal disease, on maintenance HD > 90 days
• age ≥ 18 years old
• thrice weekly HD

You may not qualify if…

• hemoglobin < 8.0 g/dL
• pregnancy
• any physical, mental or medical condition which limited the ability to provide written informed consent

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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