Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation
NCT ID: NCT02698917
Last Updated: 2018-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2016-03-22
2018-05-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Group 1
Low normal PaCO2, low normal PaO2, low normal MAP
Low normal PaCO2
4.5-4.7 kPa
Low normal PaO2
10-15 kPa
Low normal MAP
65-75 mmHg
Group 2
High normal PaCO2, low normal PaO2, low normal MAP
High normal PaCO2
5.8-6.0 kPa
Low normal PaO2
10-15 kPa
Low normal MAP
65-75 mmHg
Group 3
Low normal PaCO2, high normal PaO2, low normal MAP
Low normal PaCO2
4.5-4.7 kPa
High normal PaO2
20-25 kPa
Low normal MAP
65-75 mmHg
Group 4
High normal PaCO2, high normal PaO2, low normal MAP
High normal PaCO2
5.8-6.0 kPa
High normal PaO2
20-25 kPa
Low normal MAP
65-75 mmHg
Group 5
Low normal PaCO2, low normal PaO2, high normal MAP
Low normal PaCO2
4.5-4.7 kPa
Low normal PaO2
10-15 kPa
High normal MAP
80-100 mmHg
Group 6
High normal PaCO2, low normal PaO2, high normal MAP
High normal PaCO2
5.8-6.0 kPa
Low normal PaO2
10-15 kPa
High normal MAP
80-100 mmHg
Group 7
Low normal PaCO2, high normal PaO2, high normal MAP
Low normal PaCO2
4.5-4.7 kPa
High normal PaO2
20-25 kPa
High normal MAP
80-100 mmHg
Group 8
High normal PaCO2, high normal PaO2, high normal MAP
High normal PaCO2
5.8-6.0 kPa
High normal PaO2
20-25 kPa
High normal MAP
80-100 mmHg
Interventions
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Low normal PaCO2
4.5-4.7 kPa
High normal PaCO2
5.8-6.0 kPa
Low normal PaO2
10-15 kPa
High normal PaO2
20-25 kPa
Low normal MAP
65-75 mmHg
High normal MAP
80-100 mmHg
Eligibility Criteria
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Inclusion Criteria
* Delay of return of spontaneous circulation (ROSC) 10-45 min from the start of the arrest
* Confirmed or suspected cardiac origin
* Mechanical ventilation
* Markedly impaired level of consciousness (no response to verbal commands and Glasgow coma scale \[GCS\] motor score \< 5)
* Deferred consent possible or likely
* Active intensive care initiated, including targeted temperature management (33-36 C)
Exclusion Criteria
* Confirmed or suspected intracranial pathology and/or suspicion of raised intracranial pressure
* Pregnancy
* Severe oxygenation problem (PaO2 / FiO2 \< 100 mmHg)
* Severe COPD
18 Years
80 Years
ALL
No
Sponsors
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Laerdal Foundation
OTHER
The Finnish Medical Association
OTHER
Orion Research Foundation
UNKNOWN
Finnish Society of Anaesthesiologists
UNKNOWN
Helsinki University Central Hospital
OTHER
Responsible Party
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Pekka Jakkula
MD
Principal Investigators
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Matti Reinikainen, Associate Professor
Role: STUDY_DIRECTOR
Kuopio University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Helsinki University Hospital
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
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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15/2015
Identifier Type: -
Identifier Source: org_study_id
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