Clinical trial NCT00392639: Clinical and Economical Interest of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA Study)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypothermia
Heart Arrest
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Alsius Corporation
name: distributed in France by
name: IST Cardiology (Le Fresne Camilly, France)
First posted: 2006-10-26
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Clinical interest of endovascular cooling versus conventional external cooling for the management of cardiac arrest from cardiac origin
timeFrame: 28 days
Secondary outcomes:
measure: Cost/efficiency ratio (endovascular versus conventional cooling)
timeFrame: at 28 days
measure: Evaluation of the paramedical burden of work
timeFrame: at 28 days
measure: Evaluation of the nurse's satisfaction index
timeFrame: at 28 days
measure: Evaluation of treatment costs: global costs and costs within the first 48 hours of hospitalization
timeFrame: at 28 days
measure: Time necessary to reach the target temperature (33°C): mean speed of temperature decrease
timeFrame: at 28 days
measure: deviations of more than 1°C compared with the target temperature during the 24 hours (24H) after reaching that target temperature
timeFrame: at 28 days
measure: mean speed of rewarming
timeFrame: at 28 days
measure: Safety of the method (type of adverse events)
timeFrame: at 28 days
measure: 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]
timeFrame: at 28 days
measure: Sequential Organ Failure Assessment [SOFA]
timeFrame: at 28 days
measure: and Organ Dysfunctions and/or Infection [ODIN] scores
timeFrame: at 28 days
measure: Simplified Acute Physiology [SAPS II]), duration of Intensive Care Unit (ICU) stay and duration of mechanical ventilation
timeFrame: at 28 days
measure: 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.
timeFrame: at 28 days and 90 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Teaching Lariboisière Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frederic BAUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
citation: Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.
citation: Nolan JP, Morley PT, Vanden Hoek TL, Hickey RW, Kloeck WG, Billi J, Bottiger BW, Morley PT, Nolan JP, Okada K, Reyes C, Shuster M, Steen PA, Weil MH, Wenzel V, Hickey RW, Carli P, Vanden Hoek TL, Atkins D; International Liaison Committee on Resuscitation. Therapeutic hypothermia after cardiac arrest: an advisory statement by the advanced life support task force of the International Liaison Committee on Resuscitation. Circulation. 2003 Jul 8;108(1):118-21. doi: 10.1161/01.CIR.0000079019.02601.90. No abstract available.
citation: International Liaison Committee on Resuscitation. 2005 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Part 4: Advanced life support. Resuscitation. 2005 Nov-Dec;67(2-3):213-47. doi: 10.1016/j.resuscitation.2005.09.018. No abstract available.
citation: Steinberg GK, Ogilvy CS, Shuer LM, Connolly ES Jr, Solomon RA, Lam A, Kassell NF, Baker CJ, Giannotta SL, Cockroft KM, Bell-Stephens TE, Allgren RL. Comparison of endovascular and surface cooling during unruptured cerebral aneurysm repair. Neurosurgery. 2004 Aug;55(2):307-14; discussion 314-5. doi: 10.1227/01.neu.0000129683.99430.8c.
citation: Al-Senani FM, Graffagnino C, Grotta JC, Saiki R, Wood D, Chung W, Palmer G, Collins KA. A prospective, multicenter pilot study to evaluate the feasibility and safety of using the CoolGard System and Icy catheter following cardiac arrest. Resuscitation. 2004 Aug;62(2):143-50. doi: 10.1016/j.resuscitation.2004.02.016.
citation: Deye N, Cariou A, Girardie P, Pichon N, Megarbane B, Midez P, Tonnelier JM, Boulain T, Outin H, Delahaye A, Cravoisy A, Mercat A, Blanc P, Santre C, Quintard H, Brivet F, Charpentier J, Garrigue D, Francois B, Quenot JP, Vincent F, Gueugniaud PY, Mira JP, Carli P, Vicaut E, Baud FJ; Clinical and Economical Impact of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA) Study Group. Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study. Circulation. 2015 Jul 21;132(3):182-93. doi: 10.1161/CIRCULATIONAHA.114.012805. Epub 2015 Jun 19.