COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest

Cardiac Arrest Clinical Trial

— COOL  

Official title:

Clinical and Neurological Outcome With Two Different Cooling Methods (Invasive and Non-invasive) After Sudden Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843297
• Other study ID #: COOL-Trial
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2009
• Last updated: February 1, 2010
• Start date: April 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia

Intervention

Device:
• Coolgard
invasive Cooling via femoral ICY-catheter
• ArcticSun
Noninvasive surface-cooling by saline-cooled thermo-vest

Other:
• Conventional treatment
Intensive care-treatment without cooling

Locations

Country	Name	City	State
Germany	University of Leipzig, Heart Center, Cardiology	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

Zeiner A, Holzer M, Sterz F, Behringer W, Schörkhuber W, Müllner 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reach the target temperature		Twenty-four hours	Yes
Primary	NSE as a parameter for cerebral damage		Seventy-two hours	Yes
Secondary	Neurologic outcome		Six months	Yes
Secondary	Survival		Six months	Yes
Secondary	Periprocedural complications		Seventy-two hours	Yes