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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | Drug | Sodium bicarbonate 1 mmol/ml |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Survived 30 Days | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | At 90 days, 180 days, and 1 year | |
| Favorable Neurological Outcome | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars W Andersen | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Southern Jutland - Aabenraa | Aabenraa | 6200 | Denmark | |||
| Aalborg University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42273960 | Derived | 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. doi: 10.1001/jama.2026.10628. Online ahead of print. |
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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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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.
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| Sodium chloride |
| Drug |
Sodium chloride 9 mg/mL |
|
| At 30 days |
| At 90 days, 180 days, and 1 year |
| Health-related Quality of Life (EQ-5D-5L) | The EQ-5D-5L is a well-established measure of health-related quality of life that is quantified as a utility (i.e. a measure of quality of life between 0 and 1). | At 30 days, 90 days, 180 days, and 1 year |
| Cerebral performance category | The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. | At 30 days, 90 days, 180 days, and 1 year |
| Sequential Organ Failure Assessment (SOFA) Score | The SOFA score is a validated and widely used measure of organ failure assessing the respiratory, nervous, cardiovascular, hepatic, coagulation, and renal systems. We will assess both the cardiovascular sub score as well as the overall SOFA score. | At 2, 24, 48 and 72 hours |
| Hospital Disposition | Hospital disposition (e.g. home, rehabilitation, nursing home, hospice) will be defined at the time of discharge from the initial acute care hospital. | At hospital discharge, up to 1 year |
| pH | Unit: None | Immediately after return of spontaneous circulation, often within 1 hour |
| Standard bicarbonate | Unit: mmol/L | Immediately after return of spontaneous circulation, often within 1 hour |
| pCO2 | Partial pressure of CO2 in arterial blood. Unit: kPa | Immediately after return of spontaneous circulation, often within 1 hour |
| Potassium | Unit: mmol/L | Immediately after return of spontaneous circulation, often within 1 hour |
| Calcium | Unit: mmol/L | Immediately after return of spontaneous circulation, often within 1 hour |
| Sodium | Unit: mmol/L | Immediately after return of spontaneous circulation, often within 1 hour |
| Lactate | Unit: mmol/L | Immediately after return of spontaneous circulation, often within 1 hour |
| 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 |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |