Trial of Variable Dialysate Bicarbonate

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Dialysis Solutions

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