Trial of Variable Dialysate Bicarbonate

Not Applicable

Recruiting

• Conditions: Adverse Symptoms; Intradialytic Hypotension; Peri-dialytic Cardiac Rhythms; Electrolyte Changes; pH Changes
• Interventions: Drug: Dialysate bicarbonate concentration; Device: Dialysate bicarbonate concentration - telemetry monitoring

• Registration Number: NCT05814146
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-14
• Study Start: 2023-08-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2026-09-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower dialysate bicarbonate	Dialysate bicarbonate concentration	A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L).
Lower dialysate bicarbonate	Dialysate bicarbonate concentration - telemetry monitoring	A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L).
Higher dialysate bicarbonate	Dialysate bicarbonate concentration	A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L).
Higher dialysate bicarbonate	Dialysate bicarbonate concentration - telemetry monitoring	A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L).

Primary Outcome Measures

Name	Time	Method
QTc prolongation	During hemodialysis procedure (during dialysate administration)	QTc prolongation, calculated as post-HD (just as HD finishing, generally 4 hours from start of HD session) minus pre-HD QTc duration, will be obtained via Holter monitoring.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States