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A Combined Microdialysis and FDG-PET Study for Detection of Brain Injury After Cardiac Arrest (COMA-PROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04774055
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Information provided by (Responsible Party):
Simon Mölström, Odense University Hospital

Brief Summary:
Brain injury remains the leading cause of death in comatose patients resuscitated from OHCA. One of the most challenging aspects in the treatment of a post-cardiac arrest patient is the assessment of the extent of brain damage. Reliable, clinical measures of ongoing brain injury have potential to guide individualized treatment and potentially improve outcomes. Persistent candidate measures to fill this role is combined cerebral metabolism monitoring assessed by jugular bulb microdialysis (JBM) and positron emission tomography (PET) of 18-Fluor deoxyglucose ([F-18]-FDG). This multimodal neuromonitoring is cutting-edge technology used in a clinical setting

Condition or disease
Cardiac Arrest Brain Injuries

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: A Combined Microdialysis and FDG-PET Study for Detection of Brain Injury in Comatose Survivors Resuscitated From Out-of-hospital Cardiac Arrest - a Pilot Study
Actual Study Start Date : February 25, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest Coma

Primary Outcome Measures :
  1. Overall CMRglc [ Time Frame: Day 0 after cardiac arrest ]
    Cerebral metabolic rate of glucose (CMRglc)

  2. Overall CMRglc [ Time Frame: Day 3 after cardiac arrest ]
    Cerebral metabolic rate of glucose (CMRglc)

Secondary Outcome Measures :
  1. Jugular bulb microdialysis (JBM) LP ratio [ Time Frame: Day 0 after cardiac arrest ]
    Correlation between time-averaged (24 h) JBM lactate/pyruvate (LP) ratio and the overall CMRglc

  2. JBM LP ratio [ Time Frame: Day 3 after cardiac arrest ]
    Correlation between time-averaged (24 h) JBM LP ratio and the overall CMRglc

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Comatose patients after OHCA admitted to the hospital with sustained return of spontaneous circulation

Inclusion Criteria:

  • Out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause
  • Sustained return of spontaneous circulation (ROSC), defined as ROSC when chest compressions have not been required for 20 consecutive minutes and signs of circulation persist
  • Unconsciousness (Glasgow Coma Scale (GCS) score of less than 8) after sustained ROSC
  • Target temperature management (TTM) is indicated.

Exclusion Criteria:

  • Conscious patient (GCS score of at least 8)
  • Female of child-bearing potential, unless a negative human chorionic gonadotropin (hCG) test can rule out pregnancy within the inclusion window
  • In-hospital cardiac arrest (IHCA)
  • OHCA of presumed non-cardiac cause, such as after trauma, dissection/rupture of major artery or arrest caused by hypoxia (i.e., drowning, hanging, etc.)
  • Known bleeding diathesis (medically induced coagulopathy does not exclude patient)
  • Suspected or confirmed acute intracranial bleeding
  • Suspected or confirmed acute ischemic stroke
  • Unwitnessed asystole
  • Known limitations in therapy and do-not-resuscitate order

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 identifier (NCT number): NCT04774055

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Contact: Simon Mølstrøm, MD +4561384008
Contact: Palle Toft, Prof

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Odense University Hospital Recruiting
Odense, Fyn, Denmark, 5000
Contact: Simon Molstrom, MD    0045-61384008   
Sponsors and Collaborators
Odense University Hospital
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Principal Investigator: Simon Mølstrøm, MD Odense University Hospital
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Responsible Party: Simon Mölström, Consultant physician, Odense University Hospital Identifier: NCT04774055    
Other Study ID Numbers: S-20150173 HLO
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Heart Arrest
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Heart Diseases
Cardiovascular Diseases