Cardiac ArrestPhase 4BIHCANCT05564130
Bicarbonate for In-Hospital Cardiac Arrest
A Phase 4 study testing Sodium bicarbonate and Sodium chloride in people with Cardiac Arrest, run by Lars Wiuff Andersen at 22 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Sodium bicarbonate and Sodium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 778 participants
- Where
- 22 sitesDenmark
- Study dates
- 6 Feb 2023to 11 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- In-hospital cardiac arrest
- Age ≥ 18 years
- Received at least one dose of adrenaline during cardiopulmonary resuscitation (CPR)
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Denmark22 sites
Hospital of Southern Jutland - Aabenraa
Aabenraa, 6200
Aalborg University Hospital
Aalborg, 9000
Aarhus University Hospital
Aarhus, 8000
Copenhagen University Hospital - Bispebjerg
Bispebjerg, 2400
Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2100
Hospital of Southwest Jutland - Esbjerg
Esbjerg, 6700
Copenhagen University Hospital - Gentofte
Gentofte Municipality, 2900
Gødstrup Hospital
Gødstrup, 7400
Copenhagen University Hospital - Herlev
Herlev, 2730
North Denmark Region Hospital - Hjørring
Hjørring, 9800
Holbæk Hospital
Holbæk, 4300
Horsens Regional Hospital
Horsens, 8700
Hvidovre Hospital
Hvidovre, 2650
Zealand University Hospital - Køge
Køge, 4600
Kolding Hospital
Kolding, 6000
Nykøbing Falster Hospital
Nykøbing Falster, 4800
Odense University Hospital
Odense, 5000
Randers Regional Hospital
Randers, 8930
Zealand University Hospital - Roskilde
Roskilde, 4000
Slagelse Hospital
Slagelse, 4200
Odense University Hospital - Svendborg
Svendborg, 5700
Viborg Regional Hospital
Viborg, 8800
About this study
Official title: Bicarbonate for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
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.
- Conditions
- Cardiac Arrest
- Being tested
- Sodium bicarbonate, Sodium chloride
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
Sodium bicarbonate 1 mmol/ml
Sodium chlorideDrug
Sodium chloride 9 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate | Experimental | 50 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. Receives: Drug: Sodium bicarbonate |
| Placebo | Placebo comparator | 50 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. Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the cardiac arrest, an average of 20 minutes
Secondary outcomes (2)
Number of Participants That Survived 30 Days
Measured: At 30 days
Number of Participants With a Favorable Neurological Outcome at 30 Days
A favorable neurological outcome will be defined as a modified Rankin Scale score of 0, 1, 2 or 3. The modified Rankin Scale is a 7-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes.
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start6 Feb 2023
- Primary completion11 Feb 2026
- Study completion11 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 778 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lars Wiuff Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor-investigator, Lars Wiuff Andersen, Aarhus University Hospital
- Investigators
- Lars W Andersen, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564130
- Sponsor's protocol ID
- 00004
- Acronym
- BIHCA
- Status last verified
- Feb 2026
- First submitted
- 27 Sep 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Granfeldt A, Kirkegaard BL, Vallentin MF, Holmberg MJ, Stankovic N, Lind PC, Kjaergaard AG, Houe N, Vested M, Isbye DL, Kristensen CM, Kjaergaard J, Zwisler ST, Lundsfryd SN, Petersen LB, Folke F, Hansen CM, Iversen KK, Schou M, Wiberg S, Riddersholm SJ, Rasmussen BS, Karlsson K, Plovsing RR, Juhl CS, Krag M, Sorensen CD, Kuhne-Qvist P, Oxlund J, Solling CG, Hansen JR, Andersen LPK, Jensen JMS, Itenov TS, Lauritzen M, Pedersen MJ, Nielsen RP, Fjeldsoe-Nielsen H, Mirzada N, Secher N, Espelund US, Eskol JR, Andersen K, Brochner AC, Nedergaard HK, Hansen PM, Henschel W, Walli AR, Sandgaard M, Asferg CL, Ciubotariu A, Rasmussen MHR, Le Breton V, Nielsen LK, Hansen FG, Braendstrup N, Thomsen IK, Sindberg B, Andersen LW; Bicarbonate for In-Hospital Cardiac Arrest (BIHCA) Investigators. Sodium Bicarbonate for In-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2026 Jun 11:e2610628. doi: 10.1001/jama.2026.10628. Online ahead of print.
PubMed 42273960
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bicarbonate for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05564130
- Acronym / sponsor ID
- BIHCA / 00004
- Conditions
- Cardiac Arrest
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 778 participants (estimated)
- Lead sponsor
- Lars Wiuff AndersenUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 11 Feb 2027 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Experimental | Drug: Sodium bicarbonate50 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 comparator | Drug: Sodium chloride50 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- In-hospital cardiac arrest
- Age ≥ 18 years
- Received at least one dose of adrenaline during cardiopulmonary resuscitation (CPR)
Key exclusion criteria (6 listed)
- 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
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 bicarbonateSodium bicarbonate 1 mmol/ml | Drug | Sodium bicarbonate |
| Sodium chlorideSodium chloride 9 mg/mL | Drug | Placebo |
Primary outcome
Number of Participants With Return of Spontaneous Circulation
Time frame: During the cardiac arrest, an average of 20 minutes
Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes
2 secondary outcomes
Number of Participants That Survived 30 Days
Time frame: At 30 days
Number of Participants With a Favorable Neurological Outcome at 30 Days
Time frame: At 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 42273960Granfeldt A, Kirkegaard BL, Vallentin MF, Holmberg MJ, Stankovic N, Lind PC, Kjaergaard AG, Houe N, Vested M, Isbye DL, Kristensen CM, Kjaergaard J, Zwisler ST, Lundsfryd SN, Petersen LB, Folke F, Hansen CM, Iversen KK, Schou M, Wiberg S, Riddersholm SJ, Rasmussen BS, Karlsson K, Plovsing RR, Juhl CS, Krag M, Sorensen CD, Kuhne-Qvist P, Oxlund J, Solling CG, Hansen JR, Andersen LPK, Jensen JMS, Itenov TS, Lauritzen M, Pedersen MJ, Nielsen RP, Fjeldsoe-Nielsen H, Mirzada N, Secher N, Espelund US, Eskol JR, Andersen K, Brochner AC, Nedergaard HK, Hansen PM, Henschel W, Walli AR, Sandgaard M, Asferg CL, Ciubotariu A, Rasmussen MHR, Le Breton V, Nielsen LK, Hansen FG, Braendstrup N, Thomsen IK, Sindberg B, Andersen LW; Bicarbonate for In-Hospital Cardiac Arrest (BIHCA) Investigators. Sodium Bicarbonate for In-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2026 Jun 11:e2610628. doi: 10.1001/jama.2026.10628. Online ahead of print.
- Individual participant dataSharing planned: Yes. 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.
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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.
Lars W Andersen principal investigator
Aarhus University Hospital
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium bicarbonate and Sodium chloride in people with Cardiac Arrest, run by Lars Wiuff Andersen at 22 sites in Denmark.
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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants With Return of Spontaneous Circulation (time frame: During the cardiac arrest, an average of 20 minutes). 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 NCT05564130, 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 17 Feb 2026.