Trial of Variable Dialysate Bicarbonate

Mass General Brigham

Status: Enrolling

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

Treatments: Device: Dialysate bicarbonate concentration - telemetry monitoring; Drug: Dialysate bicarbonate concentration

Study type: Interventional

Funder types: Other

Identifiers

NCT05814146

2022P002944

Details and patient eligibility

About

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.

Enrollment: 141 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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141 participants in 2 patient groups

Lower dialysate bicarbonate

Experimental group

Description:

A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L).

Treatment:

Drug: Dialysate bicarbonate concentration

Device: Dialysate bicarbonate concentration - telemetry monitoring

Higher dialysate bicarbonate

Active Comparator group

Description:

A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L).

Treatment:

Drug: Dialysate bicarbonate concentration

Device: Dialysate bicarbonate concentration - telemetry monitoring