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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 4

Conditions: Heart Arrest; Hypothermia

Treatments: Procedure: Comparison of 2 cooling procedures

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00392639

P051038

Details and patient eligibility

About

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.

Full 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.

Enrollment: 389 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

389 participants in 1 patient group

1-2

Experimental group

Description:

Comparison of 2 cooling procedures

Treatment:

Procedure: Comparison of 2 cooling procedures