NCT00392639

Brief Summary

According to international guidelines, mild therapeutic hypothermia is recommended for resuscitated patients after cardiac arrest due to ventricular fibrillation. Whether external or internal cooling is superior in terms of prognosis or security remains unknown. The aim of this study is to evaluate in a randomized trial the clinical and economical interests of the endovascular cooling versus the conventional external cooling for the management of hypothermia after cardiac arrest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
389

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

October 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 1, 2009

Status Verified

July 1, 2007

Enrollment Period

3 years

First QC Date

October 25, 2006

Last Update Submit

November 30, 2009

Conditions

HypothermiaHeart Arrest

Keywords

Heart arrestCardiopulmonary resuscitationHumansHypothermiaBrain diseasesHypoxia-ischemiaCost Benefit AnalysisProspective studyComparative studyTreatment outcomeHypothermia forout-of-hospital cardiac arrestfrom cardiac originsuccessfully resuscitated

Outcome Measures

Primary Outcomes (1)

  • Clinical interest of endovascular cooling versus conventional external cooling for the management of cardiac arrest from cardiac origin

    28 days

Secondary Outcomes (13)

  • Cost/efficiency ratio (endovascular versus conventional cooling)

    at 28 days

  • Evaluation of the paramedical burden of work

    at 28 days

  • Evaluation of the nurse's satisfaction index

    at 28 days

  • Evaluation of treatment costs: global costs and costs within the first 48 hours of hospitalization

    at 28 days

  • Time necessary to reach the target temperature (33°C): mean speed of temperature decrease

    at 28 days

  • +8 more secondary outcomes

Study Arms (1)

1-2

EXPERIMENTAL

Comparison of 2 cooling procedures

Procedure: Comparison of 2 cooling procedures

Interventions

Comparison of 2 cooling proceduresPROCEDURE

Comparison of 2 cooling procedures

1-2

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 79 years old
  • Out-of-hospital cardiac arrest (OH-CA) due to a presumed cardiac etiology
  • Delay between OH-CA and return of spontaneous circulation (ROSC) \< 60 minutes
  • Delay between ROSC and starting cooling \< 240 minutes
  • Patient not obeying verbal command after ROSC and prior to starting cooling
  • Availability of the "CoolGard" device (ALSIUS product)

You may not qualify if:

  • Known pregnancy
  • Clinical hemorrhagic syndrome or known coagulopathy
  • Contra-indication to device usage (such as femoral venous access impossible)
  • Hypothermia at admission \< 30°C
  • Etiology of OH-CA thought to be extra-cardiac (trauma, bleeding or anoxia)
  • In hospital cardiac arrest
  • Refractory shock (need for extra-corporeal life support)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teaching Lariboisière Hospital

Paris, 75010, France

Location

Related Publications (7)

  • Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.

    PMID: 11856794RESULT

  • Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.

    PMID: 11856793RESULT

  • Nolan JP, Morley PT, Vanden Hoek TL, Hickey RW, Kloeck WG, Billi J, Bottiger BW, Morley PT, Nolan JP, Okada K, Reyes C, Shuster M, Steen PA, Weil MH, Wenzel V, Hickey RW, Carli P, Vanden Hoek TL, Atkins D; International Liaison Committee on Resuscitation. Therapeutic hypothermia after cardiac arrest: an advisory statement by the advanced life support task force of the International Liaison Committee on Resuscitation. Circulation. 2003 Jul 8;108(1):118-21. doi: 10.1161/01.CIR.0000079019.02601.90. No abstract available.

    PMID: 12847056RESULT

  • International Liaison Committee on Resuscitation. 2005 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Part 4: Advanced life support. Resuscitation. 2005 Nov-Dec;67(2-3):213-47. doi: 10.1016/j.resuscitation.2005.09.018. No abstract available.

    PMID: 16324990RESULT

  • Steinberg GK, Ogilvy CS, Shuer LM, Connolly ES Jr, Solomon RA, Lam A, Kassell NF, Baker CJ, Giannotta SL, Cockroft KM, Bell-Stephens TE, Allgren RL. Comparison of endovascular and surface cooling during unruptured cerebral aneurysm repair. Neurosurgery. 2004 Aug;55(2):307-14; discussion 314-5. doi: 10.1227/01.neu.0000129683.99430.8c.

    PMID: 15271236RESULT

  • Al-Senani FM, Graffagnino C, Grotta JC, Saiki R, Wood D, Chung W, Palmer G, Collins KA. A prospective, multicenter pilot study to evaluate the feasibility and safety of using the CoolGard System and Icy catheter following cardiac arrest. Resuscitation. 2004 Aug;62(2):143-50. doi: 10.1016/j.resuscitation.2004.02.016.

    PMID: 15294399RESULT

  • Deye N, Cariou A, Girardie P, Pichon N, Megarbane B, Midez P, Tonnelier JM, Boulain T, Outin H, Delahaye A, Cravoisy A, Mercat A, Blanc P, Santre C, Quintard H, Brivet F, Charpentier J, Garrigue D, Francois B, Quenot JP, Vincent F, Gueugniaud PY, Mira JP, Carli P, Vicaut E, Baud FJ; Clinical and Economical Impact of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA) Study Group. Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study. Circulation. 2015 Jul 21;132(3):182-93. doi: 10.1161/CIRCULATIONAHA.114.012805. Epub 2015 Jun 19.

    PMID: 26092673DERIVED

MeSH Terms

Conditions

HypothermiaHeart ArrestBrain DiseasesOut-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Frederic BAUD, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2006

First Posted

October 26, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 1, 2009

Record last verified: 2007-07

Locations

FR(1)