NCT02035839

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 26, 2018

Status Verified

May 1, 2017

Enrollment Period

2.1 years

First QC Date

November 27, 2013

Last Update Submit

June 25, 2018

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Target Temperature ManagementCooling comatose survivors from OHCAGood neurological outcome at modified Rankin Score (mRS) ≤ 3

Outcome Measures

Primary Outcomes (1)

  • 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 (23)

  • 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

    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

    26 hours

  • Treatment Success: 4. rate of cooling in °C per hour

    Per hour

  • Treatment Success: 5. rate of rewarming in °C per hour

    Per hour

  • +18 more secondary outcomes

Study Arms (3)

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

Target Temperature Management of 34°CDEVICE

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

Target Temperature Management of 34°C
Target Temperature Management of 32°CDEVICE

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

Target Temperature Management of 32°C
Target Temperature Management of 33°CDEVICE

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

Target Temperature Management of 33°C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent (obtained from their legal representative)
  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

The Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Hospital Universitario La Paz. Planta

Madrid, Pso. de La Castellana, 26128046, Spain

Location

H. Principe de Asturias

Alcalá de Henares, Spain

Location

Germans Trias i Pujol University Hospital

Badalona, Spain

Location

Hospital de Sant Pau

Barcelona, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Spain

Location

Hospital General Universitario Gregorio Marañón.

Madrid, 28007, Spain

Location

Hospital San Carlos

Madrid, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 88-182, 37007, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, 38320, Spain

Location

H. University of Santiago de Compostela

Santiago de Compostela, Spain

Location

Hospital Universitarion Virgen de la Macarena

Seville, Spain

Location

Hospital Universitario Araba Txagorritxu

Vitoria-Gasteiz, 01009, Spain

Location

Related Publications (1)

  • 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.

    PMID: 30343315DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Prof. Esteban Lopez-de-Sa, M.D

    Hospital Universitario La Paz. Planta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2013

First Posted

January 14, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 26, 2018

Record last verified: 2017-05

Locations

DE(1)ES(13)