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

Phase 4

Completed

• Conditions: Hypothermia; Heart Arrest
• Interventions: Procedure: Comparison of 2 cooling procedures

• Registration Number: NCT00392639
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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 Timeline

• Study First Submitted: 2006-10-25
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-26
• Study Start: 2006-11
• Status Verified: 2007-07
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-30
• Last Update Posted: 2009-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

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)

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-2	Comparison of 2 cooling procedures	Comparison of 2 cooling procedures

Primary Outcome Measures

Name	Time	Method
Clinical interest of endovascular cooling versus conventional external cooling for the management of cardiac arrest from cardiac origin	28 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Teaching Lariboisière Hospital; 🇫🇷 Paris, France