Bicarbonate for In-Hospital Cardiac Arrest
BIHCA
1 other identifier
interventional
778
1 country
22
Brief Summary
This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of sodium bicarbonate during adult in-hospital cardiac arrest. There will be 22 enrolling sites in Denmark. 778 adult patients with in-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2023
Longer than P75 for phase_4
22 active sites
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
First Submitted
Initial submission to the registry
September 27, 2022
CompletedFirst Posted
Study publicly available on registry
October 3, 2022
CompletedStudy Start
First participant enrolled
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2027
ExpectedFebruary 17, 2026
February 1, 2026
3 years
September 27, 2022
February 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Return of Spontaneous Circulation
Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes
During the cardiac arrest, an average of 20 minutes
Secondary Outcomes (2)
Number of Participants That Survived 30 Days
At 30 days
Number of Participants With a Favorable Neurological Outcome at 30 Days
At 30 days
Other Outcomes (13)
Survival
At 90 days, 180 days, and 1 year
Favorable Neurological Outcome
At 90 days, 180 days, and 1 year
Health-related Quality of Life (EQ-5D-5L)
At 30 days, 90 days, 180 days, and 1 year
- +10 more other outcomes
Study Arms (2)
Sodium bicarbonate
EXPERIMENTAL50 ml of 1 mmol/ml sodium bicarbonate given as soon as possible after the first dose of adrenaline. If the patient remains in cardiac arrest, one additional dose of 50 ml of 1 mmol/ml sodium bicarbonate will be administered after the second dose of adrenaline dose for a maximum of two doses.
Placebo
PLACEBO COMPARATOR50 mL of 9 mg/mL NaCl ("normal saline") given as soon as possible after the first dose of adrenaline. If the patient remains in cardiac arrest, one additional dose of 50 mL of 9 mg/mL NaCl will be administered after the second dose of adrenaline dose for a maximum of two doses.
Interventions
Eligibility Criteria
You may qualify if:
- In-hospital cardiac arrest
- Age ≥ 18 years
- Received at least one dose of adrenaline during cardiopulmonary resuscitation (CPR)
You may not qualify if:
- Clearly documented "do-not-resuscitate" order prior to the cardiac arrest
- Prior enrollment in the trial
- Invasive mechanical circulatory support at the time of the cardiac arrest
- Known or suspected pregnancy at the time of the cardiac arrest
- Known objection by the patient to participate in the trial
- Clinical indication for bicarbonate administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuscollaborator
- Lars Wiuff Andersenlead
Study Sites (22)
Hospital of Southern Jutland - Aabenraa
Aabenraa, 6200, Denmark
Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus, 8000, Denmark
Copenhagen University Hospital - Bispebjerg
Bispebjerg, 2400, Denmark
Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2100, Denmark
Hospital of Southwest Jutland - Esbjerg
Esbjerg, 6700, Denmark
Copenhagen University Hospital - Gentofte
Gentofte Municipality, 2900, Denmark
Gødstrup Hospital
Gødstrup, 7400, Denmark
Copenhagen University Hospital - Herlev
Herlev, 2730, Denmark
North Denmark Region Hospital - Hjørring
Hjørring, 9800, Denmark
Holbæk Hospital
Holbæk, 4300, Denmark
Horsens Regional Hospital
Horsens, 8700, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Kolding Hospital
Kolding, 6000, Denmark
Zealand University Hospital - Køge
Køge, 4600, Denmark
Nykøbing Falster Hospital
Nykøbing Falster, 4800, Denmark
Odense University Hospital
Odense, 5000, Denmark
Randers Regional Hospital
Randers, 8930, Denmark
Zealand University Hospital - Roskilde
Roskilde, 4000, Denmark
Slagelse Hospital
Slagelse, 4200, Denmark
Odense University Hospital - Svendborg
Svendborg, 5700, Denmark
Viborg Regional Hospital
Viborg, 8800, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars W Andersen
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 27, 2022
First Posted
October 3, 2022
Study Start
February 6, 2023
Primary Completion
February 11, 2026
Study Completion (Estimated)
February 11, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Access Criteria
- Data will be available for any research purpose to all interested parties who have approval from an independent review committee and who have a methodological sound proposal as determined by the steering committee of the current trial. Only the methodological qualities and not the purpose or objective of the proposal will be considered. Interested parties will be able to request the data by contacting the principal investigator. Authorship of publications emerging from the shared data will follow standard authorship guidelines from the International Committee of Medical Journal Editors and might or might not include authors from the steering committee depending on the nature of their involvement.
Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing. Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. Data will be completely anonymized according to Danish law. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data. There will be no predetermined end date for the data sharing.