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Trial record 16 of 667 for:    CARBON DIOXIDE AND arterial

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

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ClinicalTrials.gov Identifier: NCT02698917
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : August 3, 2018
Sponsor:
Collaborators:
Laerdal Foundation
The Finnish Medical Association
Orion Research Foundation
Finnish Society of Anaesthesiologists
Information provided by (Responsible Party):
Pekka Jakkula, Helsinki University Central Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Out-of-Hospital Cardiac Arrest Other: Low normal PaCO2 Other: High normal PaCO2 Other: Low normal PaO2 Other: High normal PaO2 Other: Low normal MAP Other: High normal MAP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The physician determining neurological outcome at six months after cardiac arrest is blinded to the study group allocations
Primary Purpose: Treatment
Official Title: Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation - Targeting High vs. Low Normal Values
Actual Study Start Date : March 22, 2016
Actual Primary Completion Date : November 3, 2017
Actual Study Completion Date : May 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1
Low normal PaCO2, low normal PaO2, low normal MAP
Other: Low normal PaCO2
4.5-4.7 kPa

Other: Low normal PaO2
10-15 kPa

Other: Low normal MAP
65-75 mmHg

Active Comparator: Group 2
High normal PaCO2, low normal PaO2, low normal MAP
Other: High normal PaCO2
5.8-6.0 kPa

Other: Low normal PaO2
10-15 kPa

Other: Low normal MAP
65-75 mmHg

Active Comparator: Group 3
Low normal PaCO2, high normal PaO2, low normal MAP
Other: Low normal PaCO2
4.5-4.7 kPa

Other: High normal PaO2
20-25 kPa

Other: Low normal MAP
65-75 mmHg

Active Comparator: Group 4
High normal PaCO2, high normal PaO2, low normal MAP
Other: High normal PaCO2
5.8-6.0 kPa

Other: High normal PaO2
20-25 kPa

Other: Low normal MAP
65-75 mmHg

Active Comparator: Group 5
Low normal PaCO2, low normal PaO2, high normal MAP
Other: Low normal PaCO2
4.5-4.7 kPa

Other: Low normal PaO2
10-15 kPa

Other: High normal MAP
80-100 mmHg

Active Comparator: Group 6
High normal PaCO2, low normal PaO2, high normal MAP
Other: High normal PaCO2
5.8-6.0 kPa

Other: Low normal PaO2
10-15 kPa

Other: High normal MAP
80-100 mmHg

Active Comparator: Group 7
Low normal PaCO2, high normal PaO2, high normal MAP
Other: Low normal PaCO2
4.5-4.7 kPa

Other: High normal PaO2
20-25 kPa

Other: High normal MAP
80-100 mmHg

Active Comparator: Group 8
High normal PaCO2, high normal PaO2, high normal MAP
Other: High normal PaCO2
5.8-6.0 kPa

Other: High normal PaO2
20-25 kPa

Other: High normal MAP
80-100 mmHg




Primary Outcome Measures :
  1. Neuron-specific enolase (NSE) serum concentration [ Time Frame: 48 hour after cardiac arrest ]

Secondary Outcome Measures :
  1. Neuron-specific enolase (NSE) serum concentration [ Time Frame: At randomization and 24 and 72 hour after cardiac arrest ]
  2. S100B protein serum concentration [ Time Frame: At randomization and 24, 48 and 72 hour after cardiac arrest ]
  3. Cardiac troponin (TnT) serum concentration [ Time Frame: At randomization and 24, 48 and 72 hour after cardiac arrest ]
  4. Cerebral oxygenation monitoring using near infrared spectroscopy (NIRS) monitoring [ Time Frame: For 48 hour after admission to ICU ]
  5. Continuous electroencephalography (EEG) monitoring [ Time Frame: For 48 hour after admission to ICU ]
  6. Functional status using cerebral performance category (CPC) classification [ Time Frame: At 30 days and 6 months after cardiac arrest ]

Other Outcome Measures:
  1. Between-group separation in PaCO2 [ Time Frame: Every 3 hour for 36 hour after admission to ICU ]
  2. Between-group separation in PaO2 [ Time Frame: Every 3 hour for 36 hour after admission to ICU ]
  3. Between-group separation in MAP [ Time Frame: Every 1 hour for 36 hour after admission to ICU ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698917


Locations
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Denmark
Aarhus University Hospital
Aarhus, Denmark
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, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
Laerdal Foundation
The Finnish Medical Association
Orion Research Foundation
Finnish Society of Anaesthesiologists
Investigators
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Study Director: Matti Reinikainen, Associate Professor Kuopio University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pekka Jakkula, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02698917     History of Changes
Other Study ID Numbers: 15/2015
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Keywords provided by Pekka Jakkula, Helsinki University Central Hospital:
Out-of-Hospital Cardiac Arrest
Resuscitation
Hypoxia-Ischemia, Brain
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases