Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation

Out-of-Hospital Cardiac Arrest Clinical Trial

— COMACARE  

Official title:

Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation - Targeting High vs. Low Normal Values

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698917
• Other study ID #: 15/2015
• Status: Completed
• Phase: N/A
• Start date: March 22, 2016
• Est. completion date: May 3, 2018

Study information

• Verified date: August 2018
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: May 3, 2018
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Witnessed out-of-hospital cardiac arrest with ventricular fibrillation (VF) or ventricular tachycardia (VT) as the initial rhythm

• 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:

• Probable withdrawal of active ICU care due to terminal illness or poor prognosis because of severely reduced functional status before cardiac arrest

• Confirmed or suspected intracranial pathology and/or suspicion of raised intracranial pressure

• Pregnancy

• Severe oxygenation problem (PaO2 / FiO2 < 100 mmHg)

• Severe COPD

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• 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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Finland	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

Sponsors (5)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Finnish Society of Anaesthesiologists, Finska Läkaresällskapet, Laerdal Foundation, Orion Research Foundation

Countries where clinical trial is conducted

Denmark,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Between-group separation in PaCO2		Every 3 hour for 36 hour after admission to ICU
Other	Between-group separation in PaO2		Every 3 hour for 36 hour after admission to ICU
Other	Between-group separation in MAP		Every 1 hour for 36 hour after admission to ICU
Primary	Neuron-specific enolase (NSE) serum concentration		48 hour after cardiac arrest
Secondary	Neuron-specific enolase (NSE) serum concentration		At randomization and 24 and 72 hour after cardiac arrest
Secondary	S100B protein serum concentration		At randomization and 24, 48 and 72 hour after cardiac arrest
Secondary	Cardiac troponin (TnT) serum concentration		At randomization and 24, 48 and 72 hour after cardiac arrest
Secondary	Cerebral oxygenation monitoring using near infrared spectroscopy (NIRS) monitoring		For 48 hour after admission to ICU
Secondary	Continuous electroencephalography (EEG) monitoring		For 48 hour after admission to ICU
Secondary	Functional status using cerebral performance category (CPC) classification		At 30 days and 6 months after cardiac arrest