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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
150
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.
The Charité - Universitätsmedizin Berlin
Berlin, Germany
Hospital Universitario La Paz. Planta
Madrid, Pso. de La Castellana, Spain
H. Principe de Asturias
Alcalá de Henares, Spain
Fraction of subjects surviving with good neurologic outcome(modified Rankin Score (mRS) ≤ 3) at 90 days after out-of-hospital cardiac arrest.
Time frame: at 90 days after out-of-hospital cardiac arrest
Treatment Success: 1. proportion of subjects that can be therapeutically cooled to randomly allocated target temperature ±0.3°C (as measured by the temperature probe)
Time frame: 24 hours
Treatment Success: 2. proportion of time at randomly allocated target temperature ±0.3°C during first 24 hours after initiation of induction of hypothermia
Time frame: 24 hours
Treatment Success: 3. time to randomly allocated target temperature, from call to 911, sustained restoration of circulation and initiation of induction of hypothermia
Time frame: 26 hours
Treatment Success: 4. rate of cooling in °C per hour
Time frame: Per hour
Treatment Success: 5. rate of rewarming in °C per hour
Time frame: Per hour
Outcomes: 1.Favorable neurologic status at 90 days (i.e. mRS < 3) measured as proportion
Time frame: 90 days
Outcomes: 2.Time to first detected mRS ≤3 (i.e. Kaplan Meier curve)
Time frame: 90 days
Outcomes: 3.Robust neurologic status at 90 days (i.e. mRS < 2) measured as proportion
Time frame: 90 days
Outcomes: 4. Time to first detected mRS ≤2 (i.e. Kaplan Meier curve)
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Germans Trias i Pujol University Hospital
Badalona, Spain
Hospital de Sant Pau
Barcelona, Spain
Hospital Universitario de Bellvitge
Barcelona, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain
Hospital General Universitario Gregorio Marañón.
Madrid, Spain
Hospital San Carlos
Madrid, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
...and 4 more locations
Time frame: 90 days
Outcomes: 5. Survival at 90 days measured as proportion
Time frame: 90 days
Outcomes: 6. Cumulative incidence of survival at 90 days (i.e. Kaplan Meier curve)
Time frame: 90 days
Outcomes: 7. ICU-free survival within 90 days measured in days
Time frame: 90 days
Outcomes: 8. Hospital-free survival within 90 days measured in days
Time frame: 90 days
Outcomes: 9. Adverse events a. Device related b. Procedure related
Time frame: 90 days
Subgroup analysis
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: 1 year
Subgroups of Special Interest Age of Patients
18 to 65 years; or (ii) \> 65 years.
Time frame: Duration of the trial
Timings of initiation of hypothermia
(ii) \> 65 years.
Time frame: <4 hours of restoration of spontaneous circulation; or > 4 hours
Patient Gender
Subgroups to assess Consistency of Effect
Time frame: Male or Female
Observational status of arrest
Time frame: Witnessed by EMS; Witnessed by bystanders
Location of cardiac arrest
Time frame: Public;Home; or Group residence (e.g. nursing home)
Bystander CPR status:
Time frame: Performed; or Not performed.
AED status:
Time frame: Applied by layperson;Applied by EMS provider;Not applied
Response time interval from call to initiation of CPR by EMS, among witnessed arrests:
Time frame: < 10 minutes;> 10 minutes.