Follow up After Survived Therapy With Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation (ROSC)

University of Leipzig

Status: Unknown

Conditions: Hypothermia; Cardiac Arrest

Study type: Observational

Funder types: Other

Identifiers

NCT01083069

Cool-Trial Follow up

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 long term neurological outcome after mild hypothermia after restoration of spontaneous circulation.

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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• survived cardiac arrest
• voluntary consent

Exclusion criteria

• no voluntary consent

Trial design

150 participants in 2 patient groups

COOL

Description:

Patients after therapy with mild hypothermia

UnCool

Description:

Patients without therapy with mild hypothermia due to non-operational cooling-devices