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Bicarbonate in Patients With Out-of-hospital Cardiac Arrest

Primary Purpose

Cardiac Arrest, Metabolic Acidosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sodium bicarbonate
Normal saline
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Sodium Bicarbonate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult cardiac arrest patient with arterial pH <7.1 or bicarbonate <10mmEq/L checked at 10 minutes of cardiopulmonary resuscitation

Exclusion Criteria:

  • age <18 trauma patient Do Not Resuscitate state

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1 (Sodium bicarbonate)

    2 (Normal saline)

    Arm Description

    Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min

    Normal saline 50cc intravenous injection over 2 min

    Outcomes

    Primary Outcome Measures

    Return of Spontaneous Circulation (ROSC)
    Percentage of Participants with Return of Spontaneous Circulation (ROSC)

    Secondary Outcome Measures

    Full Information

    First Posted
    November 23, 2014
    Last Updated
    February 28, 2022
    Sponsor
    Asan Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02303548
    Brief Title
    Bicarbonate in Patients With Out-of-hospital Cardiac Arrest
    Official Title
    Pilot Study of Bicarbonate Injection for Improving Outcome in Patients With Out-of-hospital Cardiac Arrest, Double-blind Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Asan Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A pilot study to evaluate the effect of sodium bicarbonate administration on cardiopulmonary resuscitation results and outcomes in cardiac arrest patient with severe metabolic acidosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrest, Metabolic Acidosis
    Keywords
    Sodium Bicarbonate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1 (Sodium bicarbonate)
    Arm Type
    Experimental
    Arm Description
    Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min
    Arm Title
    2 (Normal saline)
    Arm Type
    Placebo Comparator
    Arm Description
    Normal saline 50cc intravenous injection over 2 min
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium bicarbonate
    Other Intervention Name(s)
    Bivon
    Intervention Description
    Administer Sodium bicarbonate 50 mEq IV over 2 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Other Intervention Name(s)
    0.9% sodium chloride
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Return of Spontaneous Circulation (ROSC)
    Description
    Percentage of Participants with Return of Spontaneous Circulation (ROSC)
    Time Frame
    checked during CPR, duration of ROSC >20 min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: adult cardiac arrest patient with arterial pH <7.1 or bicarbonate <10mmEq/L checked at 10 minutes of cardiopulmonary resuscitation Exclusion Criteria: age <18 trauma patient Do Not Resuscitate state

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29850134
    Citation
    Ahn S, Kim YJ, Sohn CH, Seo DW, Lim KS, Donnino MW, Kim WY. Sodium bicarbonate on severe metabolic acidosis during prolonged cardiopulmonary resuscitation: a double-blind, randomized, placebo-controlled pilot study. J Thorac Dis. 2018 Apr;10(4):2295-2302. doi: 10.21037/jtd.2018.03.124.
    Results Reference
    derived

    Learn more about this trial

    Bicarbonate in Patients With Out-of-hospital Cardiac Arrest

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