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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00392639

Collaborator

Alsius Corporation (Industry), distributed in France by (Other), IST Cardiology (Le Fresne Camilly, France) (Other)

389

Enrollment

Location

Arm

Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia Heart Arrest	Procedure: Comparison of 2 cooling procedures	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

389 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

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)

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1-2 Comparison of 2 cooling procedures	Procedure: Comparison of 2 cooling procedures Comparison of 2 cooling procedures

Arm

Intervention/Treatment

Experimental: 1-2

Comparison of 2 cooling procedures

Procedure: Comparison of 2 cooling procedures

Comparison of 2 cooling procedures

Outcome Measures

Primary Outcome Measures

Clinical interest of endovascular cooling versus conventional external cooling for the management of cardiac arrest from cardiac origin [28 days]

Secondary Outcome Measures

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]
deviations of more than 1°C compared with the target temperature during the 24 hours (24H) after reaching that target temperature [at 28 days]
mean speed of rewarming [at 28 days]
Safety of the method (type of adverse events) [at 28 days]
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]
Sequential Organ Failure Assessment [SOFA] [at 28 days]
and Organ Dysfunctions and/or Infection [ODIN] scores [at 28 days]
Simplified Acute Physiology [SAPS II]), duration of Intensive Care Unit (ICU) stay and duration of mechanical ventilation [at 28 days]
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]