Finding the Optimal Cooling tempeRature After Out-of-HoSpiTal Cardiac Arrest
Not Applicable
Completed
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Registration Number
- NCT02035839
- Lead Sponsor
- ZOLL Circulation, Inc., USA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Signed informed consent (obtained from their legal representative)
- 18 years of age or older and less than 80 years old.
- Witnessed OHCA of presumed cardiac cause
- Sustained ROSC (when chest compressions have not been required for 20 consecutive minutes and signs of circulation persist)
- Initial shockable cardiac rhythm (documented by ECG or AED)
- Interval from collapse to advance life support < 20 minutes
- Interval from collapse to ROSC < 60 minutes
- Lack of meaningful response to verbal commands upon arrival to hospital after suffering non-traumatic cardiac arrest in an out-of-hospital setting
- Systolic blood pressure of >90 maintained for a least 30 minutes post-ROSC without pressors, or with a stable dose of pressors
Exclusion Criteria
- Traumatic cardiac arrest
- Toxicological etiology
- Known or suspected pregnancy
- Do Not Attempt to Resuscitate order in force
- Unwitnessed arrest
- In-Hospital arrest
- Anatomy, previous surgery or disease state contraindicating femoral venous access
- Received neuromuscular blocking agents prior to assessing level of consciousness following ROSC
- Neurological evaluation insufficient/incomplete after ROSC but prior to randomization.
- Body core temperature < 34ºC at randomization
- Current Inferior Vena Cava (IVC) filter
- Known history of acute neurological illness or severe functional disabilities prior to arrest (e.g., seizures, traumatic brain injury, increased intracranial pressures, intra-cerebral hemorrhage, etc).
- Known hypersensitivity to hypothermia including a history of Raynaud's disease
- Suspected or confirmed acute intracranial bleeding
- Suspected or confirmed acute stroke
- Terminal illness or life expectancy of less than 3 months prior to arrest
- Currently enrolled in another investigational new drug or device trial that has not completed the primary endpoint or that clinically interferes with this Trial's endpoints (For the purpose of this protocol, subjects involved in extended follow-up trials or registries for products that are currently commercially available are not considered enrolled in an investigational trial).
- Transferred from a non-participating hospital.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Fraction of subjects surviving with good neurologic outcome(modified Rankin Score (mRS) ≤ 3) at 90 days after out-of-hospital cardiac arrest. at 90 days after out-of-hospital cardiac arrest
- Secondary Outcome Measures
Name Time Method Observational status of arrest Witnessed by EMS; Witnessed by bystanders Outcomes: 1.Favorable neurologic status at 90 days (i.e. mRS < 3) measured as proportion 90 days Outcomes: 8. Hospital-free survival within 90 days measured in days 90 days Treatment Success: 2. proportion of time at randomly allocated target temperature ±0.3°C during first 24 hours after initiation of induction of hypothermia 24 hours Outcomes: 3.Robust neurologic status at 90 days (i.e. mRS < 2) measured as proportion 90 days Treatment Success: 5. rate of rewarming in °C per hour Per hour Outcomes: 4. Time to first detected mRS ≤2 (i.e. Kaplan Meier curve) 90 days Subgroups of Special Interest Age of Patients Duration of the trial 18 to 65 years; or (ii) \> 65 years.
Outcomes: 7. ICU-free survival within 90 days measured in days 90 days Outcomes: 9. Adverse events a. Device related b. Procedure related 90 days Subgroup analysis 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.
Timings of initiation of hypothermia <4 hours of restoration of spontaneous circulation; or > 4 hours (ii) \> 65 years.
Patient Gender Male or Female Subgroups to assess Consistency of Effect
Response time interval from call to initiation of CPR by EMS, among witnessed arrests: < 10 minutes;> 10 minutes. Bystander CPR status: Performed; or Not performed. AED status: Applied by layperson;Applied by EMS provider;Not applied Location of cardiac arrest Public;Home; or Group residence (e.g. nursing home) 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) 24 hours Treatment Success: 4. rate of cooling in °C per hour Per hour Outcomes: 5. Survival at 90 days measured as proportion 90 days Treatment Success: 3. time to randomly allocated target temperature, from call to 911, sustained restoration of circulation and initiation of induction of hypothermia 26 hours Outcomes: 2.Time to first detected mRS ≤3 (i.e. Kaplan Meier curve) 90 days Outcomes: 6. Cumulative incidence of survival at 90 days (i.e. Kaplan Meier curve) 90 days
Trial Locations
- Locations (14)
The Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Hospital Universitario La Paz. Planta
🇪🇸Madrid, Pso. De La Castellana, Spain
H. Principe de Asturias
🇪🇸Alcala de Henares, Spain
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
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