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

June 25, 2018 updated by: ZOLL Circulation, Inc., USA

A Pilot Multicenter Randomized Trial on the Effectiveness of Different Levels of Cooling in Comatose Survivors of Out-of-hospital Cardiac Arrest.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • The Charité - Universitätsmedizin Berlin
  • Spain
      • Alcala de Henares, Spain
        • H. Príncipe de Asturias
      • Badalona, Spain
        • Germans Trias i Pujol University Hospital
      • Barcelona, Spain
        • Hospital de Sant Pau
      • Barcelona, Spain
        • Hospital Universitario de Bellvitge
      • Girona, Spain
        • Hospital Universitari de Girona Doctor Josep Trueta
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón.
      • Madrid, Spain
        • Hospital San Carlos
      • Salamanca, Spain, 88-182, 37007
        • Hospital Universitario de Salamanca
      • Santa Cruz de Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Santiago de Compostela, Spain
        • H. University of Santiago de Compostela
      • Sevilla, Spain
        • Hospital Universitarion Virgen de la Macarena
      • Vitoria, Spain, 01009
        • Hospital Universitario Araba Txagorritxu
    • Pso. De La Castellana
      • Madrid, Pso. De La Castellana, Spain, 26128046
        • Hospital Universitario La Paz. Planta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
at 90 days after out-of-hospital cardiac arrest

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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)
Time Frame: 24 hours
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
Time Frame: 24 hours
24 hours
Treatment Success: 3. time to randomly allocated target temperature, from call to 911, sustained restoration of circulation and initiation of induction of hypothermia
Time Frame: 26 hours
26 hours
Treatment Success: 4. rate of cooling in °C per hour
Time Frame: Per hour
Per hour
Treatment Success: 5. rate of rewarming in °C per hour
Time Frame: Per hour
Per hour
Outcomes: 1.Favorable neurologic status at 90 days (i.e. mRS < 3) measured as proportion
Time Frame: 90 days
90 days
Outcomes: 2.Time to first detected mRS ≤3 (i.e. Kaplan Meier curve)
Time Frame: 90 days
90 days
Outcomes: 3.Robust neurologic status at 90 days (i.e. mRS < 2) measured as proportion
Time Frame: 90 days
90 days
Outcomes: 4. Time to first detected mRS ≤2 (i.e. Kaplan Meier curve)
Time Frame: 90 days
90 days
Outcomes: 5. Survival at 90 days measured as proportion
Time Frame: 90 days
90 days
Outcomes: 6. Cumulative incidence of survival at 90 days (i.e. Kaplan Meier curve)
Time Frame: 90 days
90 days
Outcomes: 7. ICU-free survival within 90 days measured in days
Time Frame: 90 days
90 days
Outcomes: 8. Hospital-free survival within 90 days measured in days
Time Frame: 90 days
90 days
Outcomes: 9. Adverse events a. Device related b. Procedure related
Time Frame: 90 days
90 days
Subgroup analysis
Time Frame: 1 year
A priori plan to assess heterogeneity of effect among specific subgroups of special interest as well as to assess the consistency of treatment effect among different subpopulations defined by each of multiple baseline characteristics of the patients. These will be assessed by repeating the primary analysis in the subgroups defined below, using interaction terms.
1 year
Subgroups of Special Interest Age of Patients
Time Frame: Duration of the trial
18 to 65 years; or (ii) > 65 years.
Duration of the trial
Timings of initiation of hypothermia
Time Frame: <4 hours of restoration of spontaneous circulation; or > 4 hours
(ii) > 65 years.
<4 hours of restoration of spontaneous circulation; or > 4 hours
Patient Gender
Time Frame: Male or Female
Subgroups to assess Consistency of Effect
Male or Female
Observational status of arrest
Time Frame: Witnessed by EMS; Witnessed by bystanders
Witnessed by EMS; Witnessed by bystanders
Location of cardiac arrest
Time Frame: Public;Home; or Group residence (e.g. nursing home)
Public;Home; or Group residence (e.g. nursing home)
Bystander CPR status:
Time Frame: Performed; or Not performed.
Performed; or Not performed.
AED status:
Time Frame: Applied by layperson;Applied by EMS provider;Not applied
Applied by layperson;Applied by EMS provider;Not applied
Response time interval from call to initiation of CPR by EMS, among witnessed arrests:
Time Frame: < 10 minutes;> 10 minutes.
< 10 minutes;> 10 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ZOLL Circulation, Inc., USA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto de Investigación Hospital Universitario La Paz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Prof. Esteban Lopez-de-Sa, M.D, Hospital Universitario La Paz. Planta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FROST Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings