Cardiac ArrestPhase 2NCT02303548
Bicarbonate in Patients With Out-of-hospital Cardiac Arrest
A Phase 2 study testing Sodium bicarbonate and Normal saline in people with Cardiac Arrest and Metabolic Acidosis, run by Asan Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Metabolic Acidosis
- What is being tested?
- Sodium bicarbonate and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult cardiac arrest patient with arterial pH <7.1 or bicarbonate <10mmEq/L checked at 10 minutes of cardiopulmonary resuscitation
Who cannot join
- age <18 trauma patient Do Not Resuscitate state
About this study
Official title: Pilot Study of Bicarbonate Injection for Improving Outcome in Patients With Out-of-hospital Cardiac Arrest, Double-blind Randomized Control Trial
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.
- Conditions
- Cardiac Arrest, Metabolic Acidosis
- Being tested
- Sodium bicarbonate, Normal saline
- Keywords
- Sodium Bicarbonate
- Medical subject headings
- Heart Arrest, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
Also called Bivon
Administer Sodium bicarbonate 50 mEq IV over 2 minutes
Normal salineDrug
Also called 0.9% sodium chloride
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 (Sodium bicarbonate) | Experimental | Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min Receives: Drug: Sodium bicarbonate |
| 2 (Normal saline) | Placebo comparator | Normal saline 50cc intravenous injection over 2 min Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of Spontaneous Circulation (ROSC)
Percentage of Participants with Return of Spontaneous Circulation (ROSC)
Measured: checked during CPR, duration of ROSC >20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Young Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303548
- Sponsor's protocol ID
- BicarbonateinCPR001
- Status last verified
- Feb 2022
- First submitted
- 23 Nov 2014
- Last updated
- 25 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29850134
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Bicarbonate Injection for Improving Outcome in Patients With Out-of-hospital Cardiac Arrest, Double-blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02303548
- Acronym / sponsor ID
- BicarbonateinCPR001
- Conditions
- Cardiac Arrest, Metabolic Acidosis
- Keywords
- Sodium Bicarbonate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Posted 31 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 (Sodium bicarbonate) | Experimental | Drug: Sodium bicarbonateSodium bicarbonate 50cc (50mEq) intravenous injection over 2 min |
| 2 (Normal saline) | Placebo comparator | Drug: Normal salineNormal saline 50cc intravenous injection over 2 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult cardiac arrest patient with arterial pH <7.1 or bicarbonate <10mmEq/L checked at 10 minutes of cardiopulmonary resuscitation
Key exclusion criteria (1 listed)
- age <18 trauma patient Do Not Resuscitate state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonateAlso: BivonAdminister Sodium bicarbonate 50 mEq IV over 2 minutes | Drug | 1 (Sodium bicarbonate) |
| Normal salineAlso: 0.9% sodium chloridePlacebo | Drug | 2 (Normal saline) |
Primary outcome
Return of Spontaneous Circulation (ROSC)
Time frame: checked during CPR, duration of ROSC >20 min
Percentage of Participants with Return of Spontaneous Circulation (ROSC)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29850134Ahn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium bicarbonate and Normal saline in people with Cardiac Arrest and Metabolic Acidosis, run by Asan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of Spontaneous Circulation (ROSC) (time frame: checked during CPR, duration of ROSC >20 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02303548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.