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Bicarbonate in Patients With Out-of-hospital Cardiac Arrest

Sponsor
Asan Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02303548
Collaborator
(none)
50
Enrollment
2
Arms
16
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sodium bicarbonate
  • Drug: Normal saline
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Pilot Study of Bicarbonate Injection for Improving Outcome in Patients With Out-of-hospital Cardiac Arrest, Double-blind Randomized Control Trial
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1 (Sodium bicarbonate)

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

Drug: Sodium bicarbonate
Administer Sodium bicarbonate 50 mEq IV over 2 minutes
Other Names:
  • Bivon

    		•
    Placebo Comparator: 2 (Normal saline)

    Normal saline 50cc intravenous injection over 2 min

    Drug: Normal saline
    Placebo
    Other Names:
  • 0.9% sodium chloride

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Return of Spontaneous Circulation (ROSC) [checked during CPR, duration of ROSC >20 min]

      Percentage of Participants with Return of Spontaneous Circulation (ROSC)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Won Young Kim, Associate proffesor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT02303548
    Other Study ID Numbers:
    • BicarbonateinCPR001
    First Posted:
    Dec 1, 2014
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by Won Young Kim, Associate proffesor, Asan Medical Center
    Sodium Bicarbonate
    Additional relevant MeSH terms:
    Heart Arrest
    Out-of-Hospital Cardiac Arrest
    Acidosis

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 1 (Sodium Bicarbonate) 2 (Normal Saline)
    Arm/Group Description Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes Normal saline 50cc intravenous injection over 2 min Normal saline: Placebo
    Period Title: Overall Study
    STARTED 25 25
    COMPLETED 25 25
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title 1 (Sodium Bicarbonate) 2 (Normal Saline) Total
    Arm/Group Description Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes Normal saline 50cc intravenous injection over 2 min Normal saline: Placebo Total of all reporting groups
    Overall Participants 25 25 50
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65.5
    (16.4)
    64.1
    (15.4)
    64.8
    (16.0)
    Sex: Female, Male (Count of Participants)
    Female
    7
    28%
    4
    16%
    11
    22%
    Male
    18
    72%
    21
    84%
    39
    78%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (Count of Participants)
    South Korea
    25
    100%
    25
    100%
    50
    100%
    pH (units on a scale) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [units on a scale]
    6.99
    6.90
    6.95
    Shockable pre-hospital rhythm (participants) [Number]
    Number [participants]
    7
    28%
    3
    12%
    10
    20%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 1 (Sodium Bicarbonate) 2 (Normal Saline)
    Arm/Group Description Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes Normal saline 50cc intravenous injection over 2 min Normal saline: Placebo
    Measure Participants 25 25
    Number [ROSC percents of each group]
    4
    16

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title 1 (Sodium Bicarbonate) 2 (Normal Saline)
    Arm/Group Description Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Sodium bicarbonate: Administer Sodium bicarbonate 50 mEq IV over 2 minutes Normal saline 50cc intravenous injection over 2 min Normal saline: Placebo
    All Cause Mortality
    1 (Sodium Bicarbonate) 2 (Normal Saline)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 24/25 (96%) 21/25 (84%)
    Serious Adverse Events
    1 (Sodium Bicarbonate) 2 (Normal Saline)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 25/25 (100%) 24/25 (96%)
    Nervous system disorders
    Severe hypoxic brain injury 25/25 (100%) 25 24/25 (96%) 24
    Other (Not Including Serious) Adverse Events
    1 (Sodium Bicarbonate) 2 (Normal Saline)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 25/25 (100%) 25/25 (100%)
    Nervous system disorders
    Severe hypoxic brain injury (<6 mo) 25/25 (100%) 25 25/25 (100%) 25

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Director of Clinical Trials
    Organization Asan Medical Center
    Phone 8230103350
    Email wonpia73@naver.com
    Responsible Party:
    Won Young Kim, Associate proffesor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT02303548
    Other Study ID Numbers:
    • BicarbonateinCPR001
    First Posted:
    Dec 1, 2014
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Feb 1, 2022