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
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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.
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
|Aarhus University Hospital, Skejby|
|Aarhus, Denmark, 8200|
|Stavanger University Hospital|