Trial of Variable Dialysate Bicarbonate
Primary Purpose
Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension, Electrolyte Changes
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dialysate bicarbonate concentration
Dialysate bicarbonate concentration - telemetry monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Peri-dialytic Cardiac Rhythms
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lower dialysate bicarbonate
Higher dialysate bicarbonate
Arm Description
A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L).
A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L).
Outcomes
Primary Outcome Measures
QTc prolongation
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05814146
First Posted
March 20, 2023
Last Updated
July 25, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05814146
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension, Electrolyte Changes, pH Changes, Adverse Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
141 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lower dialysate bicarbonate
Arm Type
Experimental
Arm Description
A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L).
Arm Title
Higher dialysate bicarbonate
Arm Type
Active Comparator
Arm Description
A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L).
Intervention Type
Drug
Intervention Name(s)
Dialysate bicarbonate concentration
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Dialysate bicarbonate concentration - telemetry monitoring
Intervention Description
Patients will be monitored with telemetry on both arms of the trial.
Primary Outcome Measure Information:
Title
QTc prolongation
Description
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.
Time Frame
During hemodialysis procedure (during dialysate administration)
Other Pre-specified Outcome Measures:
Title
PVC frequency
Description
Holter monitors will be used to assess PVC frequency during HD sessions and in the subsequent inter-HD period. The investigators will also assess PVC coupling interval variability in these time intervals.
Time Frame
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.
Title
Clinically significant arrhythmia
Description
As described in the Monitoring in Dialysis (MiD) study, clinically significant arrhythmia is defined as: sustained ventricular tachycardia, bradycardia, asystole and symptomatic arrhythmias.
Time Frame
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).
Title
Intradialytic hypotension
Description
Intradialytic hypotension will be defined as systolic blood pressure <90 during hemodialysis. The investigators will also conduct sensitivity analyses using alternative definitions of intradialytic hypotension (e.g. nadir intra-hemodialysis systolic blood pressure <90mmHg if pre-hemodialysis systolic blood pressure is <160mmHg or nadir intra-hemodialysis systolic blood pressure <100mmHg if pre-hemodialysis systolic blood pressure is ≥160mmHg). Additionally, the investigators will examine the overall mean decline in systolic blood pressure during hemodialysis as a continuous outcome (intra-hemodialysis systolic blood pressure decline=pre-hemodialysis systolic blood pressure minus nadir systolic blood pressure during hemodialysis).
Time Frame
Blood pressures will be measured every 15 minutes during HD sessions.
Title
Electrolytes
Description
Samples are collected from the hemodialysis circuit (no extra blood sticks) for freezing for comprehensive metabolic panels.
Time Frame
Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).
Title
pH
Description
Samples are collected from the hemodialysis circuit (no extra blood sticks) for immediate blood gas analysis.
Time Frame
Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).
Title
Ionized calcium level
Description
Samples are collected from the hemodialysis circuit (no extra blood sticks) for immediate evaluation of ionized calcium level.
Time Frame
Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).
Title
Adverse symptoms
Description
The investigators will administer the modified Edmonton Symptom Assessment System (mESAS). The mESAS measures patient-reported severity of pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath and pruritus using a 0-10 score (anchored by "No" at 0 and "Severe" at 10). A validated Spanish version is available and a translator will help to administer the questionnaire as well as with all communication with patients in any language other than English.
Time Frame
Questionnaires will be administered during the last 10 minutes of hemodialysis sessions.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine S Ravi, MD, MPH
Phone
(617) 732-6383
Email
ksravi@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine S Ravi, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Trial of Variable Dialysate Bicarbonate
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