Hypothermia After In-hospital Cardiac Arrest

NCT ID: NCT00457431

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-03
• Study Completion Date: 2021-03-01

Brief Summary

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.

Detailed 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.

Conditions

Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Standard therapy as used in the hospital's ICU

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hypothermia

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

Group Type: ACTIVE_COMPARATOR

Mild therapeutic hypothermia

Intervention Type: PROCEDURE

Mild therapeutic hypothermia will be performed by any methods applicable in the hospitals

Interventions

Mild therapeutic hypothermia

Mild therapeutic hypothermia will be performed by any methods applicable in the hospitals

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: collaborator

University of Jena

OTHER

Sponsor Role: collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Sebastian Wolfrum

D. Sebastian Wolfrum

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebastian Wolfrum, MD

Role: PRINCIPAL_INVESTIGATOR

University of Schleswig-Holstein, Campus Luebeck, Medical Clinic II

Locations

Sebastian Wolfrum

Lübeck, Schleswig-Holstein, Germany

Countries

Germany

References

Wolfrum S, Roedl K, Hanebutte A, Pfeifer R, Kurowski V, Riessen R, Daubmann A, Braune S, Soffker G, Bibiza-Freiwald E, Wegscheider K, Schunkert H, Thiele H, Kluge S; Hypothermia After In-Hospital Cardiac Arrest Study Group. Temperature Control After In-Hospital Cardiac Arrest: A Randomized Clinical Trial. Circulation. 2022 Nov;146(18):1357-1366. doi: 10.1161/CIRCULATIONAHA.122.060106. Epub 2022 Sep 28.

Reference Type: DERIVED

PMID: 36168956 (View on PubMed)

Soar J, Nolan JP. Mild hypothermia for post cardiac arrest syndrome. BMJ. 2007 Sep 8;335(7618):459-60. doi: 10.1136/bmj.39315.519201.BE.

Reference Type: DERIVED

PMID: 17823147 (View on PubMed)

Other Identifiers

HACA in-hospital

Identifier Type: -

Identifier Source: org_study_id