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Neurological Prognostication of Patients in Therapeutic Hypothermia After Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT02390999
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
Aarhus University Hospital
Roche Diagnostics
ThermoFisher Scientific Brahms Biomarkers France
Regionshospitalet Hammel Neurocenter
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

3500 people suffer from out of hospital cardiac arrest each year in Denmark. Therapeutic hypothermia to 33 degrees celsius is now standard treatment of comatose cardiac arrest patients. The investigators are challenged in our attempt to predict outcome of these patients by both low body temperature in itself and the sedative and relaxing drugs used to keep the patient in a coma.

This study is a substudy in a large international multicenter randomized trial that investigates the possible benefit of 48 hours of therapeutic hypothermia versus todays standard of 24 hours.

In this substudy the investigators will approach early prediction of neurological outcome using a combination of new examinations backed up by well established ones to engage this challenge from different angles and find a battery of combined examinations, that together will enable us to accurately predict outcome at an earlier stage.

Our examinations have been chosen from the three fields of neurophysiology, biochemistry and neurology and consist of electroencephalography (EEG), somatosensory evoked potentials (SEP), biomarkers and clinical examinations such as brain stem reflexes chosen for their prognostic reliability.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Procedure: 48 hours of therapeutic hypothermia Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Neurological Prognostication of Patients in Therapeutic Hypothermia After Cardiac Arrest
Study Start Date : March 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 24 hours of therapeutic hypothermia
24 hours of therapeutic hypothermia to a target temperature of 32-34 degrees in comatose cardiac arrest patients is standard treatment in Denmark.
Experimental: 48 hours of therapeutic hypothermia
48 hours of therapeutic hypothermia to a target temperature of 32-34 degrees
Procedure: 48 hours of therapeutic hypothermia



Primary Outcome Measures :
  1. Glasgow-Pittsburgh Cerebral Performance Categories (CPC) after 6 months [ Time Frame: 6 months ]
    To evaluate neurologic recovery using the Glasgow-Pittsburgh Cerebral Performance Categories (CPC) 6 months after cardiac arrest. The CPC-score will be dichotomized in good (CPC 1-2) and poor (CPC 3-5) outcome.


Secondary Outcome Measures :
  1. Area under the curve [ Time Frame: 72 hours ]
    Assess total release of bloodsamples NSE, S100B, Copeptin and NT-proBNP measured as area under the curve and compare the 24hrs group to the 48hrs group from hrs 24 to 72 hours after reaching target temperature.


Other Outcome Measures:
  1. Presence of brainstem reflexes [ Time Frame: 72 hours ]
    Comparison of presence and loss of brainstem reflexes (pupillary light reflex, Oculocephalic reflex and corneal reflex) in 24 vs 48 hour groups. Reflexes are categorized as "present" or "non-present" and are measured at 24, 48 and 72 hours after target temperature as long as the patient is unconscious.



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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:

  • Out-of-hospital cardiac arrest with presumable cardiac origin
  • Restored spontaneous circulation after resuscitation (No need for cardiac compressions during 20 min, and clinical sign of circulation)
  • Glasgow Coma Score (GCS) < 8
  • Age >= 18, < 80 years

Exclusion Criteria:

  • Estimated time interval from collapse to return of spontaneous circulation>60 min
  • Cardiac arrest with presumable non-cardiac origin (hypoxia etc.).
  • In hospital cardiac arrest
  • Terminal disease
  • Coagulopathy (anticoagulation treatment including thrombolysis is not an exclusion criteria)
  • Unwitnessed asystolia
  • Time from cardiac arrest to initiation of cooling>240 min.
  • Pregnancy
  • Persistent cardiogenic shock, systolic blood pressure<80 mmHg despite vasoactive treatment
  • Cerebral performance category (CPC) 3-4 before cardiac arrest.
  • Suspicious or confirmed intracerebral bleeding
  • Suspicious or confirmed acute stroke
  • Acute CABG
  • No informed consent from relatives
  • No informed consent from general practitioner
  • Patient unstable
  • Other reason

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): NCT02390999


Locations
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Denmark
Aarhus University Hospital, Skejby
Aarhus, Denmark, 8200
Norway
Stavanger University Hospital
Stavanger, Norway
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Roche Diagnostics
ThermoFisher Scientific Brahms Biomarkers France
Regionshospitalet Hammel Neurocenter

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02390999     History of Changes
Other Study ID Numbers: Neuroprognostication in CA
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: February 2015

Additional relevant MeSH terms:
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Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms