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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by ZOLL Circulation, Inc., USA
Sponsor:
Collaborator:
Instituto de Investigación Hospital Universitario La Paz
Information provided by (Responsible Party):
ZOLL Circulation, Inc., USA
ClinicalTrials.gov Identifier:
NCT02035839
First received: November 27, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Out-Of-Hospital Cardiac Arrest.
Device: Target Temperature Management of 34°C
Device: Target Temperature Management of 32°C
Device: Target Temperature Management of 33°C

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Multicenter Randomized Trial on the Effectiveness of Different Levels of Cooling in Comatose Survivors of Out-of-hospital Cardiac Arrest.

Resource links provided by NLM:


Further study details as provided by ZOLL Circulation, Inc., USA:

Primary Outcome Measures:
  • Fraction of subjects surviving with good neurologic outcome(modified Rankin Score (mRS) ≤ 3) at 90 days after out-of-hospital cardiac arrest. [ Time Frame: at 90 days after out-of-hospital cardiac arrest ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fraction of subjects with good neurologic outcome (mRS ≤ 3) at discharge after out-of-hospital cardiac arrest [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 days after out-of-hospital cardiac arrest ] [ Designated as safety issue: No ]
  • Identify possible covariates influencing survival with good neurological outcome. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • To assess safety with each target temperature with regard to bleeding, infection, renal impairment, hypokalemia and arrhythmia. [ Time Frame: 72 hours and 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: March 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Target Temperature Management of 34°C
In hospital target temperature management to achieve core body temperature of 34°C for 24 hours.
Device: Target Temperature Management of 34°C
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.
Device: Target Temperature Management of 32°C
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.
Device: Target Temperature Management of 33°C
In hospital target temperature management to achieve core body temperature of 33°C for 24 hours.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035839

Contacts
Contact: Diana Villegas, M.D., Ph.D. 1 (408) 419-2321 dvillegas@zoll.com

Locations
Spain
Hospital Universitario La Paz. Planta Recruiting
Madrid, Pso. de la castellana, Spain, 26128046
Contact: Prof. Esteban Lopez-de-Sa, M.D    +34 91 207 1990    e.lopezdesa@terra.com   
Principal Investigator: Prof. Esteban Lopez-de-Sa, M.D         
H. Principe de Asturias Not yet recruiting
Alcala de Henares, Spain
Contact: Patricia Villa         
Contact: Jose Cambronero         
Principal Investigator: Patricia Villa         
Hospital Universitario de Bellvitge Not yet recruiting
Barcelona, Spain
Contact: Jose Carlos Sánchez         
Contact: Angel Cequier         
Principal Investigator: Jose Carlos Sánchez         
Hospital de Sant Pau Not yet recruiting
Barcelona, Spain
Contact: Alessandro Sionis         
Principal Investigator: Alessandro Sionis         
Hospital Universitari de Girona Doctor Josep Trueta Recruiting
Girona, Spain
Contact: Pablo Loma         
Principal Investigator: Pablo Loma         
H. Universitario Fundación Jiménez Díaz. Madrid Not yet recruiting
Madrid, Spain
Contact: Cesar Perez         
Contact: Roberto Martin         
Principal Investigator: Cesar Perez         
Hospital General Universitario Gregorio Marañón. Not yet recruiting
Madrid, Spain, 28007
Contact: Miriam Juarez    (+34) 91 586 8293    mijufernandez@secardiologia.es   
Contact: Hector Bueno       hecbueno@jet.es   
Principal Investigator: Miriam Juarez         
Hospital San Carlos Not yet recruiting
Madrid, Spain
Contact: Juan Carlos Martin         
Contact: Miguel Sanchez         
Principal Investigator: Juan Carlos Martin         
Sponsors and Collaborators
ZOLL Circulation, Inc., USA
Instituto de Investigación Hospital Universitario La Paz
Investigators
Principal Investigator: Prof. Esteban Lopez-de-Sa, M.D Hospital Universitario La Paz. Planta
  More Information

Additional Information:
No publications provided

Responsible Party: ZOLL Circulation, Inc., USA
ClinicalTrials.gov Identifier: NCT02035839     History of Changes
Other Study ID Numbers: FROST I-Trial
Study First Received: November 27, 2013
Last Updated: June 26, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by ZOLL Circulation, Inc., USA:
Target Temperature Management
cooling comatose survivors from out-of- hospital cardiac arrest
Good neurological outcome at modified Rankin Score (mRS) ≤ 3

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014