Clinical trial NCT00843297: COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest
Official title: Clinical and Neurological Outcome With Two Different Cooling Methods (Invasive and Non-invasive) After Sudden Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Arrest
Hypothermia
Keywords: Sudden Cardiac Arrest
Hypothermia
Outcome, neurological
Coolgard
ArcticSun
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.

Detailed description: Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC). Blood samples of neuron-specific enolase (NSE) were collected during 72 hours.

Eligibility criteria: Inclusion Criteria:

* ROSC after SCA due to VF/VT or PEA/Asystolia
* GCS 3

Exclusion Criteria:

* Non-cardiac SCA
* Pregnancy
* Unstable Circulation instead of High-dose Inotropics
* Life-expectancy reducing concomitant illness

Primary outcomes:
measure: Time to reach the target temperature
timeFrame: Twenty-four hours
measure: NSE as a parameter for cerebral damage
timeFrame: Seventy-two hours
Secondary outcomes:
measure: Neurologic outcome
timeFrame: Six months
measure: Survival
timeFrame: Six months
measure: Periprocedural complications
timeFrame: Seventy-two hours
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig, Heart Center, Cardiology
Study officials:
affiliation: Study Chair
name: Holger Thiele, Associate Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Sub-Investigator
name: Undine Pittl, MD
role: STUDY_DIRECTOR
References:
citation: Zeiner A, Holzer M, Sterz F, Behringer W, Schorkhuber W, Mullner M, Frass M, Siostrzonek P, Ratheiser K, Kaff A, Laggner AN. Mild resuscitative hypothermia to improve neurological outcome after cardiac arrest. A clinical feasibility trial. Hypothermia After Cardiac Arrest (HACA) Study Group. Stroke. 2000 Jan;31(1):86-94. doi: 10.1161/01.str.31.1.86.
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.