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

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ClinicalTrials.gov Identifier: NCT00392639
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : December 1, 2009
Sponsor:
Collaborators:
Alsius Corporation
distributed in France by
IST Cardiology (Le Fresne Camilly, France)
Information provided by:
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.

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.


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Study Type : Interventional  (Clinical Trial)
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 : November 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Clinical interest of endovascular cooling versus conventional external cooling for the management of cardiac arrest from cardiac origin [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Cost/efficiency ratio (endovascular versus conventional cooling) [ Time Frame: at 28 days ]
  2. Evaluation of the paramedical burden of work [ Time Frame: at 28 days ]
  3. Evaluation of the nurse's satisfaction index [ Time Frame: at 28 days ]
  4. Evaluation of treatment costs: global costs and costs within the first 48 hours of hospitalization [ Time Frame: at 28 days ]
  5. Time necessary to reach the target temperature (33°C): mean speed of temperature decrease [ Time Frame: at 28 days ]
  6. deviations of more than 1°C compared with the target temperature during the 24 hours (24H) after reaching that target temperature [ Time Frame: at 28 days ]
  7. mean speed of rewarming [ Time Frame: at 28 days ]
  8. Safety of the method (type of adverse events) [ Time Frame: at 28 days ]
  9. 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] [ Time Frame: at 28 days ]
  10. Sequential Organ Failure Assessment [SOFA] [ Time Frame: at 28 days ]
  11. and Organ Dysfunctions and/or Infection [ODIN] scores [ Time Frame: at 28 days ]
  12. Simplified Acute Physiology [SAPS II]), duration of Intensive Care Unit (ICU) stay and duration of mechanical ventilation [ Time Frame: at 28 days ]
  13. 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. [ Time Frame: at 28 days and 90 days ]


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392639


Locations
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France
Teaching Lariboisière Hospital
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Alsius Corporation
distributed in France by
IST Cardiology (Le Fresne Camilly, France)
Investigators
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Principal Investigator: Frederic BAUD, MD Assistance Publique - Hôpitaux de Paris

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mathieu QUINTIN, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00392639     History of Changes
Other Study ID Numbers: P051038
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: July 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
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

Additional relevant MeSH terms:
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Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms