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

University of Leipzig

Status and phase: Completed; Phase 4

Conditions: Hypothermia; Cardiac Arrest

Treatments: Other: Conventional treatment; Device: ArcticSun; Device: Coolgard

Study type: Interventional

Funder types: Other

Identifiers

NCT00843297

COOL-Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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120 participants in 3 patient groups

CG

Active Comparator group

Description:

Coolgard: invasive Cooling

Treatment:

Device: Coolgard

AS

Active Comparator group

Description:

ArcticSun: Surface-Cooling

Treatment:

Device: ArcticSun

UnCOOL

Sham Comparator group

Description:

No Cooling-Therapy due to non-operational cooling-devices

Treatment:

Other: Conventional treatment