Target Temperature Management of 34°C
DeviceIn hospital target temperature management to achieve core body temperature of 34°C for 24 hours.
NCT Number: NCT02035839
To assess the fraction of subjects surviving with good neurological outcome at 90 days for 3 different levels of hypothermia, in comatose survivors from out-of-hospital cardiac arrest.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
The Charité - Universitätsmedizin Berlin, Berlin, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In hospital target temperature management to achieve core body temperature of 34°C for 24 hours.
In hospital target temperature management to achieve core body temperature of 32°C for 24 hours.
In hospital target temperature management to achieve core body temperature of 33°C for 24 hours.
Time frame: at 90 days after out-of-hospital cardiac arrest
Time frame: 24 hours
Time frame: 24 hours
Time frame: 26 hours
Time frame: Per hour
Time frame: Per hour
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 1 year
A priori plan to assess heterogeneity of effect among specific subgroups of special interest as well as to assess the consistency of treatment effect among different subpopulations defined by each of multiple baseline characteristics of the patients. These will be assessed by repeating the primary analysis in the subgroups defined below, using interaction terms.
Time frame: Duration of the trial
18 to 65 years; or (ii) > 65 years.
Time frame: <4 hours of restoration of spontaneous circulation; or > 4 hours
(ii) > 65 years.
Time frame: Male or Female
Subgroups to assess Consistency of Effect
Time frame: Witnessed by EMS; Witnessed by bystanders
Time frame: Public;Home; or Group residence (e.g. nursing home)
Time frame: Performed; or Not performed.
Time frame: Applied by layperson;Applied by EMS provider;Not applied
Time frame: < 10 minutes;> 10 minutes.
ZOLL Circulation, Inc., USA
Industry
A Pilot Multicenter Randomized Trial on the Effectiveness of Different Levels of Cooling in Comatose Survivors of Out-of-hospital Cardiac Arrest.
Acronym: FROST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03835403
Cardiovascular Diseases, Heart Arrest
Copenhagen, Ballerup, Denmark
View Trial DetailsNCT02309151
Cardiovascular Diseases, Heart Arrest
Aalborg, Denmark
View Trial DetailsNCT04237727
Cardiovascular Diseases, Heart Arrest
Amersfoort, Utrecht, Netherlands
View Trial DetailsNCT05062785
Cardiovascular Diseases, Healthy
Ann Arbor, Michigan, United States
View Trial Details