Finding the Optimal Cooling tempeRature After Out-of-HoSp... | NCT02035839

Status Module

Name	Class
Instituto de Investigación Hospital Universitario La Paz	OTHER

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Target Temperature Management of 34°C	Other	In hospital target temperature management to achieve core body temperature of 34°C for 24 hours.	Device: Target Temperature Management of 34°C
Target Temperature Management of 32°C	Other	In hospital target temperature management to achieve core body temperature of 32°C for 24 hours.	Device: Target Temperature Management of 32°C
Target Temperature Management of 33°C	Other	In hospital target temperature management to achieve core body temperature of 33°C for 24 hours.	Device: Target Temperature Management of 33°C

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Target Temperature Management of 34°C	Device	In hospital target temperature management to achieve core body temperature of 34°C for 24 hours.	Target Temperature Management of 34°C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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: 2. proportion of time at randomly allocated target temperature ±0.3°C during first 24 hours after initiation of induction of hypothermia

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Prof. Esteban Lopez-de-Sa, M.D	Hospital Universitario La Paz. Planta	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Charité - Universitätsmedizin Berlin		Berlin		13353	Germany
Hospital Universitario La Paz. Planta

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30343315	Derived	Lopez-de-Sa E, Juarez M, Armada E, Sanchez-Salado JC, Sanchez PL, Loma-Osorio P, Sionis A, Monedero MC, Martinez-Selles M, Martin-Benitez JC, Ariza A, Uribarri A, Garcia-Acuna JM, Villa P, Perez PJ, Storm C, Dee A, Lopez-Sendon JL. A multicentre randomized pilot trial on the effectiveness of different levels of cooling in comatose survivors of out-of-hospital cardiac arrest: the FROST-I trial. Intensive Care Med. 2018 Nov;44(11):1807-1815. doi: 10.1007/s00134-018-5256-z. Epub 2018 Oct 21.