Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Laerdal Foundation | OTHER |
| The Finnish Medical Association | OTHER |
| Orion Research Foundation | UNKNOWN |
| Finnish Society of Anaesthesiologists |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The COMACARE trial is a pilot multicenter randomized trial to assess the feasibility and effect on brain injury markers of targeting low or high normal arterial oxygen tension (PaO2), arterial carbon dioxide tension (PaCO2) and mean arterial pressure (MAP) in comatose, mechanically ventilated patients after out-of-hospital cardiac arrest. Using factorial design, participants are randomized at admission to intensive care unit to one of eight groups targeting either low or high normal values of PaO2, PaCO2 and MAP for 36 h. In this way, investigators will be assessing the feasibility and effect of all three variables at the same time.
The primary outcome is serum concentration of neuron-specific enolase (NSE) at 48 h after cardiac arrest. Feasibility outcome is between-group separation in PaO2, PaCO2 and MAP levels. Secondary outcomes include continuous monitoring of cerebral oxygenation, EEG and ECG for 48 h, the levels of NSE, S100B and cardiac troponin at randomization and 24, 48 and 72 h after cardiac arrest and neurological assessment at 6 months after cardiac arrest.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Low normal PaCO2, low normal PaO2, low normal MAP |
|
| Group 2 | Active Comparator | High normal PaCO2, low normal PaO2, low normal MAP |
|
| Group 3 | Active Comparator | Low normal PaCO2, high normal PaO2, low normal MAP |
|
| Group 4 | Active Comparator | High normal PaCO2, high normal PaO2, low normal MAP |
|
| Group 5 | Active Comparator | Low normal PaCO2, low normal PaO2, high normal MAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low normal PaCO2 | Other | 4.5-4.7 kPa |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuron-specific enolase (NSE) serum concentration | 48 hour after cardiac arrest |
| Measure | Description | Time Frame |
|---|---|---|
| Neuron-specific enolase (NSE) serum concentration | At randomization and 24 and 72 hour after cardiac arrest | |
| S100B protein serum concentration | At randomization and 24, 48 and 72 hour after cardiac arrest |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group separation in PaCO2 | Every 3 hour for 36 hour after admission to ICU | |
| Between-group separation in PaO2 | Every 3 hour for 36 hour after admission to ICU | |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matti Reinikainen, Associate Professor | Kuopio University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark | ||||
| Helsinki University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37987871 | Derived | Laurikkala J, Ameloot K, Reinikainen M, Palmers PJ, De Deyne C, Bert F, Dupont M, Janssens S, Dens J, Hastbacka J, Jakkula P, Loisa P, Birkelund T, Wilkman E, Vaara ST, Skrifvars MB. The effect of higher or lower mean arterial pressure on kidney function after cardiac arrest: a post hoc analysis of the COMACARE and NEUROPROTECT trials. Ann Intensive Care. 2023 Nov 21;13(1):113. doi: 10.1186/s13613-023-01210-0. | |
| 34863908 |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 3, 2022 | |
| Reset | Apr 7, 2022 |
Not provided
| UNKNOWN |
Not provided
Not provided
Not provided
The physician determining neurological outcome at six months after cardiac arrest is blinded to the study group allocations
| Group 6 |
| Active Comparator |
High normal PaCO2, low normal PaO2, high normal MAP |
|
| Group 7 | Active Comparator | Low normal PaCO2, high normal PaO2, high normal MAP |
|
| Group 8 | Active Comparator | High normal PaCO2, high normal PaO2, high normal MAP |
|
| High normal PaCO2 | Other | 5.8-6.0 kPa |
|
| Low normal PaO2 | Other | 10-15 kPa |
|
| High normal PaO2 | Other | 20-25 kPa |
|
| Low normal MAP | Other | 65-75 mmHg |
|
| High normal MAP | Other | 80-100 mmHg |
|
| Cardiac troponin (TnT) serum concentration | At randomization and 24, 48 and 72 hour after cardiac arrest |
| Cerebral oxygenation monitoring using near infrared spectroscopy (NIRS) monitoring | For 48 hour after admission to ICU |
| Continuous electroencephalography (EEG) monitoring | For 48 hour after admission to ICU |
| Functional status using cerebral performance category (CPC) classification | At 30 days and 6 months after cardiac arrest |
| Between-group separation in MAP |
| Every 1 hour for 36 hour after admission to ICU |
| Helsinki |
| Finland |
| North Karelia Central Hospital | Joensuu | Finland |
| Central Finland Central Hospital | Jyväskylä | Finland |
| Kuopio University Hospital | Kuopio | Finland |
| Päijät-Häme Central Hospital | Lahti | Finland |
| Tampere University Hospital | Tampere | Finland |
| Derived |
| Humaloja J, Lahde M, Ashton NJ, Reinikainen M, Hastbacka J, Jakkula P, Friberg H, Cronberg T, Pettila V, Blennow K, Zetterberg H, Skrifvars MB; COMACARE Study Groups. GFAp and tau protein as predictors of neurological outcome after out-of-hospital cardiac arrest: A post hoc analysis of the COMACARE trial. Resuscitation. 2022 Jan;170:141-149. doi: 10.1016/j.resuscitation.2021.11.033. Epub 2021 Dec 1. |
| 34583763 | Derived | Laurikkala J, Aneman A, Peng A, Reinikainen M, Pham P, Jakkula P, Hastbacka J, Wilkman E, Loisa P, Toppila J, Birkelund T, Blennow K, Zetterberg H, Skrifvars MB. Association of deranged cerebrovascular reactivity with brain injury following cardiac arrest: a post-hoc analysis of the COMACARE trial. Crit Care. 2021 Sep 28;25(1):350. doi: 10.1186/s13054-021-03764-6. |
| 32792079 | Derived | Ameloot K, Jakkula P, Hastbacka J, Reinikainen M, Pettila V, Loisa P, Tiainen M, Bendel S, Birkelund T, Belmans A, Palmers PJ, Bogaerts E, Lemmens R, De Deyne C, Ferdinande B, Dupont M, Janssens S, Dens J, Skrifvars MB. Optimum Blood Pressure in Patients With Shock After Acute Myocardial Infarction and Cardiac Arrest. J Am Coll Cardiol. 2020 Aug 18;76(7):812-824. doi: 10.1016/j.jacc.2020.06.043. |
| 31088512 | Derived | Jakkula P, Hastbacka J, Reinikainen M, Pettila V, Loisa P, Tiainen M, Wilkman E, Bendel S, Birkelund T, Pulkkinen A, Backlund M, Heino S, Karlsson S, Kopponen H, Skrifvars MB. Near-infrared spectroscopy after out-of-hospital cardiac arrest. Crit Care. 2019 May 14;23(1):171. doi: 10.1186/s13054-019-2428-3. |
| 30430209 | Derived | Jakkula P, Reinikainen M, Hastbacka J, Loisa P, Tiainen M, Pettila V, Toppila J, Lahde M, Backlund M, Okkonen M, Bendel S, Birkelund T, Pulkkinen A, Heinonen J, Tikka T, Skrifvars MB; COMACARE study group. Targeting two different levels of both arterial carbon dioxide and arterial oxygen after cardiac arrest and resuscitation: a randomised pilot trial. Intensive Care Med. 2018 Dec;44(12):2112-2121. doi: 10.1007/s00134-018-5453-9. Epub 2018 Nov 14. |
| 29084585 | Derived | Jakkula P, Reinikainen M, Hastbacka J, Pettila V, Loisa P, Karlsson S, Laru-Sompa R, Bendel S, Oksanen T, Birkelund T, Tiainen M, Toppila J, Hakkarainen A, Skrifvars MB; COMACARE study group. Targeting low- or high-normal Carbon dioxide, Oxygen, and Mean arterial pressure After Cardiac Arrest and REsuscitation: study protocol for a randomized pilot trial. Trials. 2017 Oct 30;18(1):507. doi: 10.1186/s13063-017-2257-0. |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 3, 2022 | Apr 7, 2022 |
| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided