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

Hypothermia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392639
• Other study ID #: P051038
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2006
• Last updated: November 30, 2009
• Start date: November 2006
• Est. completion date: November 2009

Study information

• Verified date: July 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Arrest
• Hypothermia

Intervention

Procedure:
• Comparison of 2 cooling procedures
Comparison of 2 cooling procedures

Locations

Country	Name	City	State
France	Teaching Lariboisière Hospital	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Alsius Corporation, distributed in France by, IST Cardiology (Le Fresne Camilly, France)

Country where clinical trial is conducted

France, 

References & Publications (6)

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. 20 — View Citation

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. — View Citation

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. — View Citation

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):21 — View Citation

Nolan JP, Morley PT, Vanden Hoek TL, Hickey RW, Kloeck WG, Billi J, Böttiger 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. — View Citation

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical interest of endovascular cooling versus conventional external cooling for the management of cardiac arrest from cardiac origin		28 days	Yes
Secondary	Cost/efficiency ratio (endovascular versus conventional cooling)		at 28 days	Yes
Secondary	Evaluation of the paramedical burden of work		at 28 days	Yes
Secondary	Evaluation of the nurse's satisfaction index		at 28 days	No
Secondary	Evaluation of treatment costs: global costs and costs within the first 48 hours of hospitalization		at 28 days	Yes
Secondary	Time necessary to reach the target temperature (33°C): mean speed of temperature decrease		at 28 days	Yes
Secondary	deviations of more than 1°C compared with the target temperature during the 24 hours (24H) after reaching that target temperature		at 28 days	Yes
Secondary	mean speed of rewarming		at 28 days	Yes
Secondary	Safety of the method (type of adverse events)		at 28 days	No
Secondary	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]		at 28 days	Yes
Secondary	Sequential Organ Failure Assessment [SOFA]		at 28 days	Yes
Secondary	and Organ Dysfunctions and/or Infection [ODIN] scores		at 28 days	Yes
Secondary	Simplified Acute Physiology [SAPS II]), duration of Intensive Care Unit (ICU) stay and duration of mechanical ventilation		at 28 days	Yes
Secondary	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.		at 28 days and 90 days	Yes