NCT00843297

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Arrest
• Hypothermia

Interventions

Type	Name	Description
DEVICE	Coolgard	invasive Cooling via femoral ICY-catheter
DEVICE	ArcticSun	Noninvasive surface-cooling by saline-cooled thermo-vest
OTHER	Conventional treatment	Intensive care-treatment without cooling

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2009-02-13
• Last updated: 2010-02-02

Locations

1 site across 1 country: Germany