Finding the Optimal Cooling tempeRature After Out-of-HoSpiTal Cardiac Arrest (NCT02035839) | Clinical Trial Compass
CompletedNot Applicable
Finding the Optimal Cooling tempeRature After Out-of-HoSpiTal Cardiac Arrest
Germany, Spain150 participantsStarted 2014-03
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-ce…
What they're measuring
1
Fraction of subjects surviving with good neurologic outcome(modified Rankin Score (mRS) ≤ 3) at 90 days after out-of-hospital cardiac arrest.
Timeframe: at 90 days after out-of-hospital cardiac arrest