Finding the Optimal Cooling tempeRature After Out-of-HoSpiTal Cardiac Arrest

NCT ID: NCT02035839

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-04-30

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.

Conditions

Out-Of-Hospital Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Target Temperature Management of 34°C

In hospital target temperature management to achieve core body temperature of 34°C for 24 hours.

Group Type: OTHER

Target Temperature Management of 34°C

Intervention Type: DEVICE

In hospital target temperature management to achieve core body temperature of 34°C for 24 hours.

Target Temperature Management of 32°C

In hospital target temperature management to achieve core body temperature of 32°C for 24 hours.

Group Type: OTHER

Target Temperature Management of 32°C

Intervention Type: DEVICE

In hospital target temperature management to achieve core body temperature of 32°C for 24 hours.

Target Temperature Management of 33°C

In hospital target temperature management to achieve core body temperature of 33°C for 24 hours.

Group Type: OTHER

Target Temperature Management of 33°C

Intervention Type: DEVICE

In hospital target temperature management to achieve core body temperature of 33°C for 24 hours.

Interventions

Target Temperature Management of 34°C

In hospital target temperature management to achieve core body temperature of 34°C for 24 hours.

Intervention Type: DEVICE

Target Temperature Management of 32°C

In hospital target temperature management to achieve core body temperature of 32°C for 24 hours.

Intervention Type: DEVICE

Target Temperature Management of 33°C

In hospital target temperature management to achieve core body temperature of 33°C for 24 hours.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role: collaborator

ZOLL Circulation, Inc., USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Esteban Lopez-de-Sa, M.D

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz. Planta

Locations

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

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

Hospital Universitario de Canarias

Santa Cruz de Tenerife, , Spain

H. University of Santiago de Compostela

Santiago de Compostela, , Spain

Hospital Universitarion Virgen de la Macarena

Seville, , Spain

Hospital Universitario Araba Txagorritxu

Vitoria-Gasteiz, , Spain

Countries

Germany; Spain

References

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.

Reference Type: DERIVED

PMID: 30343315 (View on PubMed)

Related Links

http://circ.ahajournals.org/

Pilot trial comparing 2 levels of target temperature. Circulation. 2012;126:2826-2833

Other Identifiers

FROST Trial

Identifier Type: -

Identifier Source: org_study_id