Therapeutic hypothermia
OtherMild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours
NCT Number: NCT01689077
The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours therapeutic hypothermia.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Department of Intensive Care, Erasme Hospital, Brussels, Belgium
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death. However, in 2002 it was in two clinical trials demonstrated that mild therapeutic hypothermia in comatose OOH-CA victims yields a better cerebral outcome measured by Cerebral Performance Category Score (CPC) after 6 month. The optimal mild hypothermia treatment time is however not known. The two trials from 2002 apply the treatment for 12 and 24 hours respectively. In newborns with cerebral hypoxic damage the standard treatment time is 72 hours. It is therefore relevant to investigate the influence of the treatment time on the cerebral outcome in OOH-CA victims. In the present study cerebral outcome after mild therapeutic hypothermia (target temperature 33 degrees centigrade) in OOH-CA patients for 24 is compared to outcome after 48 hours of mild hypothermia. The main outcome parameter is mortality and CPC score measured 6 month after the treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours
Time frame: 6 month
CPC = Cerebral Performance Category Score. The primary outcome of the study is analyzed as the proportion of patients with good neurological outcome in the two groups, (CPC 1-2) at 6 months after CA.
Time frame: 10 days
Adverse events are registered during the treatment and until discharge from primary hospital unit
Time frame: 3 month
CPC at discharge from primary hospital unit and after 28 days plus after 3 month
Time frame: 6 month
CPC 5 at 6 month
Time frame: 28 days
Glasgow Coma Score at day 4 and at discharge from primary hospital unit
Time frame: 25 weeks
Glasgow Coma Score throughout the observation period
University of Aarhus
Other
Time-differentiated Treatment With Mild Therapeutic Hypothermia Following Cardiac Arrest, a Multi Center Study.
Acronym: TTH48
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