Hypothermia After In-hospital Cardiac Arrest (HACAinhospital)

University Hospital Schleswig-Holstein (UKSH)

Status: Terminated

Conditions: Cardiac Arrest

Treatments: Procedure: Mild therapeutic hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT00457431

HACA in-hospital

Details and patient eligibility

About

ILCOR Recommendations "On the basis of the published evidence to date, the Advanced Life Support (ALS) Task Force of the International Liaison Committee on Resuscitation (ILCOR) made the following recommendations in October 2002: Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32°C to 34°C for 12 to 24 hours when the initial rhythm was ventricular fibrillation (VF).Such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest" (Circulation. 2003;108:118-121). This study ist to investigate the efficacy of mild therapeutic hypothermia on mortality and neurological outcome in patients after in-hospital cardiac arrest.

Full description

This is a randomized controlled multicenter trial. Patients after in-hospital cardiac arrest are randomized either to standard therapy or to standard therapy in addition to mild therapeutic hypothermia. Mild therapeutic hypothermia is performed for 24 hours with a target temperature of 32-34°C. Inclusion criteria are: Adult patients which have been resuscitated after cardiac arrest in-hospital and who remain unconscious after restoration of spontanous circulation. Exclusion criteria are: severe cardiogenic shock, severe rhythm disorders, major surgery within the last 10 days, planned surgery within the next 24 hours afer resuscitation, active bleeding, suspicion od intracranial bleeding, severe infection, such as pneumonia or sepsis, a severe neurological deficit before cardiac arrest, an aquired immun deficency, pregnacy. The primary endpoint is mortality for all causes after six months. Secondary endpoints are neurological outcome after six months measured by the Glasgow-Pittsburgh Cerebral Performance scale, and in-hospital-mortality.

Enrollment: 249 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• in-hospital cardiac arrest
• restoration of spontanous circulation
• unconsciousness
• age over 18
• initiation of mild therapeutic hypothermia is possible within 4h after resuscitation

Exclusion criteria

• active bleeding
• suspicion of intra cranial bleeding
• severe infection
• aquired immun deficency
• severe rhythm disorders
• suspicion of cerebral insult
• known severe cognotive deficit before the index event
• pregnancy
• pre existing disease which makes 6 months survival unlikely

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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249 participants in 2 patient groups

Control

No Intervention group

Description:

Standard therapy as used in the hospital's ICU

Hypothermia

Active Comparator group

Description:

Standard therapy as used in the hospital's ICU plus Hypothermia

Treatment:

Procedure: Mild therapeutic hypothermia