Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
141 participants
INTERVENTIONAL
2023-08-24
2026-10-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lower dialysate bicarbonate
A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L).
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
Dialysate bicarbonate concentration - telemetry monitoring
Patients will be monitored with telemetry on both arms of the trial.
Higher dialysate bicarbonate
A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L).
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
Dialysate bicarbonate concentration - telemetry monitoring
Patients will be monitored with telemetry on both arms of the trial.
Interventions
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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
Dialysate bicarbonate concentration - telemetry monitoring
Patients will be monitored with telemetry on both arms of the trial.
Eligibility Criteria
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Inclusion Criteria
* age ≥ 18 years old
* thrice weekly HD
Exclusion Criteria
* pregnancy
* any physical, mental or medical condition which limited the ability to provide written informed consent
18 Years
120 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Katherine Scovner Ravi, MD, MPH
Instructor Harvard Medical School / Associate Physician Renal Division
Principal Investigators
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Katherine S Ravi, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Katherine S Ravi, MD, MPH
Role: primary
Other Identifiers
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2022P002944
Identifier Type: -
Identifier Source: org_study_id
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