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

ZOLL Medical

Status: Completed

Conditions: Out-Of-Hospital Cardiac Arrest

Treatments: Device: Target Temperature Management of 33°C; Device: Target Temperature Management of 32°C; Device: Target Temperature Management of 34°C

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02035839

FROST Trial

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Target Temperature Management of 34°C

Other group

Description:

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

Treatment:

Device: Target Temperature Management of 34°C

Target Temperature Management of 32°C

Other group

Description:

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

Treatment:

Device: Target Temperature Management of 32°C

Target Temperature Management of 33°C

Other group

Description:

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

Treatment:

Device: Target Temperature Management of 33°C