Clinical and Economical Interest of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA Study) - Full Text View

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris Alsius Corporation distributed in France by IST Cardiology (Le Fresne Camilly, France)
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00392639

Purpose

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.

Condition	Intervention	Phase
Hypothermia Heart Arrest	Procedure: Comparison of 2 cooling procedures	Phase IV

MedlinePlus related topics: Hypothermia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Clinical Interest of Endovascular Cooling in the Management of Cardiac Arrest: Impact on Mortality in a Randomized Medico-Economical Trial (the ICEREA Study)

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Clinical interest of endovascular cooling versus conventional external cooling for the management of cardiac arrest from cardiac origin [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cost/efficiency ratio (endovascular versus conventional cooling) [ Time Frame: at 28 days ] [ Designated as safety issue: Yes ]
Evaluation of the paramedical burden of work [ Time Frame: at 28 days ] [ Designated as safety issue: Yes ]
Evaluation of the nurse's satisfaction index [ Time Frame: at 28 days ] [ Designated as safety issue: No ]
Evaluation of treatment costs: global costs and costs within the first 48 hours of hospitalization [ Time Frame: at 28 days ] [ Designated as safety issue: Yes ]
Time necessary to reach the target temperature (33°C): mean speed of temperature decrease [ Time Frame: at 28 days ] [ Designated as safety issue: Yes ]
deviations of more than 1°C compared with the target temperature during the 24 hours (24H) after reaching that target temperature [ Time Frame: at 28 days ] [ Designated as safety issue: Yes ]
mean speed of rewarming [ Time Frame: at 28 days ] [ Designated as safety issue: Yes ]
Safety of the method (type of adverse events) [ Time Frame: at 28 days ] [ Designated as safety issue: No ]
Analysis according to the type and the cause of the cardiac arrest, duration of resuscitation maneuvers, success of coronary angioplasty, number of organ failures (Logistic Organ Dysfunction System [LODS] [ Time Frame: at 28 days ] [ Designated as safety issue: Yes ]
Sequential Organ Failure Assessment [SOFA] [ Time Frame: at 28 days ] [ Designated as safety issue: Yes ]
and Organ Dysfunctions and/or Infection [ODIN] scores [ Time Frame: at 28 days ] [ Designated as safety issue: Yes ]
Simplified Acute Physiology [SAPS II]), duration of Intensive Care Unit (ICU) stay and duration of mechanical ventilation [ Time Frame: at 28 days ] [ Designated as safety issue: Yes ]
The efficiency is measured on survival and on better neurological outcome, as defined by CPC 1 or 2 on the Pittsburgh cerebral performance categories (CPC), with an expected 12% improvement of the survival without major sequels at day 28 after inclusion. [ Time Frame: at 28 days and 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1-2: Experimental Comparison of 2 cooling procedures	Procedure: Comparison of 2 cooling procedures Comparison of 2 cooling procedures

Detailed Description:

According to international guidelines, mild therapeutic hypothermia is recommended for resuscitated patients after experiencing cardiac arrest from cardiac origin: "unconscious adult patients with spontaneous circulation after cardiac arrest should be cooled to 32-34°C for 12-24 hours when the initial rhythm was ventricular fibrillation" or pulseless ventricular tachycardia. "Such cooling may also be beneficial for other rhythm or in-hospital cardiac arrest". "External or internal cooling techniques can be used to initiate cooling within minutes to hours". The two main randomized and positive studies dealing with the efficiency of hypothermia after cardiac arrest have used external cooling systems. However, several animal studies documented the importance of initiating hypothermia as soon as possible after cardiac arrest. Intravascular cooling enables more rapid induction of hypothermia compared with external cooling method after brain injury. Although several human studies have also documented that intravascular cooling provides more precise control of core temperature than external methods and although an endovascular method has been used safely in pilot studies in those experiencing hypothermia after cardiac arrest, the superiority of such a cooling on the prognosis after cardiac arrest remains unknown, as well as its cost efficiency. The aim of this study is to evaluate in a randomized trial the potential clinical and economical interests of the endovascular cooling versus the conventional external cooling for the management of cardiac arrest from cardiac origin. With a clinical primary endpoint (survival without major neurological sequels), this study will also focus on important secondary endpoints, as the burden of nurse work and the economical costs induced by these 2 different methods of cooling.

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

Do not reanimate order or terminal disease before inclusion
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392639

Contacts

Contact: Frederic BAUD, MD

+33(0)- 1 49 95 64 91

frederic.baud@lrb.aphp.fr

Locations

France
Teaching Lariboisière Hospital	Recruiting
PARIS, France, 75010
Contact: Frederic BAUD, MD +33(0)- 1 49 95 64 91 frederic.baud@lrb.aphp.fr
Principal Investigator: Frederic BAUD, MD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Alsius Corporation

distributed in France by

IST Cardiology (Le Fresne Camilly, France)

Investigators

Principal Investigator:

Frederic BAUD, MD

Assistance Publique - Hôpitaux de Paris

More Information

Publications:

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.

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. Erratum in: N Engl J Med 2002 May 30;346(22):1756.

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. No abstract available.

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. No abstract available.

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.

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.

Responsible Party:	Department Clinical Research of Developpement ( Mathieu QUINTIN )
Study ID Numbers:	P051038, AOM05091
Study First Received:	October 25, 2006
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00392639 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Heart arrest
Cardiopulmonary resuscitation
Humans
Hypothermia
Brain diseases
Hypoxia-ischemia
Cost Benefit Analysis

Prospective study
Comparative study
Treatment outcome
Hypothermia for
out-of-hospital cardiac arrest
from cardiac origin
successfully resuscitated

Study placed in the following topic categories:

Signs and Symptoms
Hypothermia
Heart Diseases

Heart Arrest
Ischemia
Brain Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Hypothermia
Heart Diseases

Cardiovascular Diseases
Heart Arrest
Body Temperature Changes

ClinicalTrials.gov processed this record on May 07, 2009