Bicarbonate in Patients With Out-of-hospital Cardiac Arrest
Pilot Study of Bicarbonate Injection for Improving Outcome in Patients With Out-of-hospital Cardiac Arrest, Double-blind Randomized Control Trial
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2014
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 23, 2014
CompletedFirst Posted
Study publicly available on registry
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
July 31, 2019
CompletedMarch 25, 2022
February 1, 2022
1.3 years
November 23, 2014
July 7, 2019
February 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Return of Spontaneous Circulation (ROSC)
Percentage of Participants with Return of Spontaneous Circulation (ROSC)
checked during CPR, duration of ROSC >20 min
Study Arms (2)
1 (Sodium bicarbonate)
EXPERIMENTALSodium bicarbonate 50cc (50mEq) intravenous injection over 2 min
2 (Normal saline)
PLACEBO COMPARATORNormal saline 50cc intravenous injection over 2 min
Interventions
Administer Sodium bicarbonate 50 mEq IV over 2 minutes
Eligibility Criteria
You may qualify if:
- adult cardiac arrest patient with arterial pH \<7.1 or bicarbonate \<10mmEq/L checked at 10 minutes of cardiopulmonary resuscitation
You may not qualify if:
- age \<18 trauma patient Do Not Resuscitate state
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29850134DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Asan Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate proffesor
Study Record Dates
First Submitted
November 23, 2014
First Posted
December 1, 2014
Study Start
October 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 25, 2022
Results First Posted
July 31, 2019
Record last verified: 2022-02