Trial of Variable Dialysate Bicarbonate

Purpose

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.

Conditions

  • Peri-dialytic Cardiac Rhythms
  • Intradialytic Hypotension
  • Electrolyte Changes
  • pH Changes
  • Adverse Symptoms

Eligibility

Eligible Ages
Between 18 Years and 120 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lower dialysate bicarbonate 		A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L).
  • Drug: Dialysate bicarbonate concentration
    Assess how a lower dialysate bicarbonate affects: - QTc duration during and between hemodialysis sessions - PVC burden during and between hemodialysis sessions - Clinically significant arrhythmia during and between hemodialysis sessions - Intradialytic hypotension - Adverse symptoms during hemodialysis sessions
  • Device: Dialysate bicarbonate concentration - telemetry monitoring
    Patients will be monitored with telemetry on both arms of the trial.
Active Comparator
Higher dialysate bicarbonate 		A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L).
  • Drug: Dialysate bicarbonate concentration
    Assess how a lower dialysate bicarbonate affects: - QTc duration during and between hemodialysis sessions - PVC burden during and between hemodialysis sessions - Clinically significant arrhythmia during and between hemodialysis sessions - Intradialytic hypotension - Adverse symptoms during hemodialysis sessions
  • Device: Dialysate bicarbonate concentration - telemetry monitoring
    Patients will be monitored with telemetry on both arms of the trial.

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Katherine S Ravi, MD, MPH
617-732-6383

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Katherine S Ravi, MD, MPH
(617) 732-6383
ksravi@bwh.harvard.edu