Clinical trial NCT05814146: Trial of Variable Dialysate Bicarbonate
Official title: Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-dialytic Cardiac Rhythms
Intradialytic Hypotension
Electrolyte Changes
pH Changes
Adverse Symptoms
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: QTc prolongation
timeFrame: During hemodialysis procedure (during dialysate administration)
Secondary outcomes:
Other outcomes:
measure: PVC frequency
timeFrame: PVCs/hour will be recorded during HD sessions and for ~44-68 hours from the end of the hemodialysis session until the subsequent hemodialysis session.
measure: Clinically significant arrhythmia
timeFrame: Clinically significant arrhythmia will be assessed during hemodialysis sessions and in the subsequent inter-hemodialysis period (until the subsequent hemodialysis session, up to 68 hours).
measure: Intradialytic hypotension
timeFrame: Blood pressures will be measured every 15 minutes during HD sessions.
measure: Electrolytes
timeFrame: Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).
measure: pH
timeFrame: Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).
measure: Ionized calcium level
timeFrame: Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).
measure: Adverse symptoms
timeFrame: Questionnaires will be administered during the last 10 minutes of hemodialysis sessions.
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Katherine S Ravi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: