search
Back to results

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
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-dialytic Cardiac Rhythms

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    March 20, 2023
    Last Updated
    July 25, 2023
    Sponsor
    Brigham and Women's Hospital
    search

    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

    Learn more about this trial

    Trial of Variable Dialysate Bicarbonate

    We'll reach out to this number within 24 hrs