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

Phase 4

Completed

• Conditions: Hypothermia; Cardiac Arrest
• Interventions: Device: ArcticSun; Device: Coolgard; Other: Conventional treatment

• Registration Number: NCT00843297
• Lead Sponsor: University of Leipzig

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Primary Completion: 2009-12
• Status Verified: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-02-01
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AS	ArcticSun	ArcticSun: Surface-Cooling
CG	Coolgard	Coolgard: invasive Cooling
UnCOOL	Conventional treatment	No Cooling-Therapy due to non-operational cooling-devices

Primary Outcome Measures

Name	Time	Method
Time to reach the target temperature	Twenty-four hours
NSE as a parameter for cerebral damage	Seventy-two hours

Secondary Outcome Measures

Name	Time	Method
Survival	Six months
Neurologic outcome	Six months
Periprocedural complications	Seventy-two hours

Trial Locations

Locations (1)

University of Leipzig, Heart Center, Cardiology; 🇩🇪 Leipzig, Germany