Clinical and Economical Interest of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA Study)
Condition: Hypothermia; Heart Arrest
MeSH terms: Heart Arrest; Hypothermia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Comparison of 2 cooling procedures
Intervention type(s): Procedure
Intervention description(s): Comparison of 2 cooling procedures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: 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