Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
778
Countries
1
Sites
21
In-hospital cardiac arrest
To determine whether sodium bicarbonate, as compared to placebo, when administered during in-hospital cardiac arrest, will increase return of spontaneous circulation.
Key facts
- Sponsor
- Aarhus University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 6 Feb 2023 → ongoing
- Decision date (initial)
- 2022-09-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Novo Nordisk Foundation
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To determine whether sodium bicarbonate, as compared to placebo, when administered during in-hospital cardiac arrest, will increase return of spontaneous circulation.
Secondary objectives 1
- To determine whether sodium bicarbonate as compared to placebo, when administered during in-hospital cardiac arrest, will increase survival at 30 days and survival at 30 days with a favorable neurological outcome.
Conditions and MedDRA coding
In-hospital cardiac arrest
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10007515 | Cardiac arrest | 100000004849 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- In-hospital cardiac arrest
- Age ≥ 18 years
- Received at least one dose of adrenaline during cardiopulmonary resuscitation
Exclusion criteria 6
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Return of spontaneous circulation
Secondary endpoints 2
- Survival at 30 days
- Survival at 30 days with a favorable neurological outcome (modified Rankin Scale score 0 - 3)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Natriumbikarbonat ”SAD”, koncentrat til infusionsvæske, opløsning
PRD322726 · Product
- Active substance
- Sodium Hydrogen Carbonate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 100 Mmol millimole(s)
- Max total dose
- 100 Mmol millimole(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA02 — SODIUM BICARBONATE
- Marketing authorisation
- 16383
- MA holder
- AMGROS I/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Natriumklorid isotonisk "SAD", injektionsvæske, opløsning
PRD349415 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 100 ml millilitre(s)
- Max total dose
- 100 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 16404
- MA holder
- AMGROS I/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus University Hospital
- Sponsor organisation
- Aarhus University Hospital
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Lars W. Andersen
Public contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Lars W. Andersen
Locations
1 EU/EEA country · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 778 | 21 |
| Rest of world | — | 0 | — |
Investigational sites
Gentofte Hospital
Department of Cardiology, Kildegaardsvej 28, 2900, Hellerup
Region Sjaelland
Department of Anesthesiology and Intensive Care, Smedelundsgade 60, 4300, Holbæk
Bispebjerg Hospital
Department of Anesthesiology and Intensive Care, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Sydvestjysk Sygehus
Department of Anesthesiology and Intensive Care, Finsensgade 35, 6700, Esbjerg
Regionshospital Nordjylland
Department of Anesthesiology and Intensive Care, Bispensgade 37, 9800, Hjoerring
Odense University Hospital
Department of Anesthesiology and Intensive Care, Valdemarsgade 53, 5700, Svendborg
Viborg Regional Hospital
Department of Anesthesiology and Intensive Care, Heibergs Alle 4, 8800, Viborg
Nykobing F. Sygehus
Department of Anesthesiology and Intensive Care, Fjordvej 15, 4800, Nykobing F
Rigshospitalet
Department of Anesthesiology, Blegdamsvej 9, 2100, Copenhagen Oe
Aalborg University Hospital
Department of Cardiology, Hobrovej 18/22, 9000, Aalborg
Regionshospitalet Horsens
Department of Anesthesiology and Intensive Care, Sundvej 30, 8700, Horsens
Kolding Hospital
Department of Anesthesiology and Intensive Care, Sygehusvej 24, 6000, Kolding
Hvidovre Hospital
Department of Anesthesiology and Intensive Care, Kettegaard Alle 30, 2650, Hvidovre
Aarhus University Hospital
Department of Anesthesiology and Intensive Care, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
Department of Anesthesiology, J B Winsloews Vej 4, 5000, Odense C
Regionshospitalet Godstrup
Department of Anesthesiology and Intensive Care, Hospitalsparken 15, 7400, Herning
Slagelse Hospital
Department of Anesthesiology and Intensive Care, Ingemannsvej 18, 4200, Slagelse
Zealand University Hospital
Department of Anesthesiology and Intensive Care, Lykkebaekvej 1, 4600, Koege
Zealand University Hospital
Department of Cardiology, Sygehusvej 10, 4000, Roskilde
Soenderborg Sygehus
Department of Anesthesiology and Intensive Care, Sydvang 1, 6400, Sønderborg
Herlev Hospital
Department of Cardiology, Herlev Ringvej 75, 2730, Herlev
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-02-06 | 2023-02-07 | 2026-02-11 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 2 · Art. 77 CTR
Corrective measure CM-DK-0002
- Member state
- Denmark
- Publication date
- 2025-09-26
- Type
- 4
- Reason
- 4
- Immediate action required
- No
- Justification
- For justification, please see attached letter. Please respond the 2 October at the latest.
Corrective measure CM-DK-0003
- Member state
- Denmark
- Publication date
- 2025-10-10
- Type
- 4
- Reason
- 4
- Immediate action required
- No
- Justification
- Please respond at the latest on 6th of October 2025.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | BIHCA protocol | 1.5 |
| Protocol (for publication) | BIHCA protocol tracked | 1.5 |
| Recruitment arrangements (for publication) | Recruitment arrangement | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation 3 | 1.3 |
| Subject information and informed consent form (for publication) | Deltagerinformation 3 TRACKED | 1.3 |
| Subject information and informed consent form (for publication) | Parrendeinformation 3 TRACKED | 1.3 |
| Subject information and informed consent form (for publication) | Parrendeinformation 3 | 1.3 |
| Subject information and informed consent form (for publication) | Parrendeinformation afdd | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | Bicarbonate SmPC Sverige | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Bicarbonate SmPC UK | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Natriumbikarbonat Produktresume | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-07-09 | Denmark | Acceptable 2022-09-26
|
2022-09-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-09-28 | Denmark | Acceptable 2022-11-07
|
2022-11-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-03-23 | Denmark | Acceptable 2023-04-18
|
2023-04-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-11 | Denmark | Acceptable 2024-09-13
|
2024-10-02 |