Clinical trial NCT00457431: Hypothermia After In-hospital Cardiac Arrest
Official title: Hypothermia After In-hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Arrest
Keywords: in-hospital cardiac arrest
resuscitation
mild therapeutic hypothermia
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: University of Hamburg-Eppendorf
name: University of Leipzig
name: University of Jena
First posted: 2007-04-06
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: all cause mortality at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale
timeFrame: 6 months
measure: in-hospital all cause mortality
timeFrame: time until discharge or death
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Sebastian Wolfrum
state: Schleswig-Holstein
Study officials:
affiliation: University of Schleswig-Holstein, Campus Luebeck, Medical Clinic II
name: Sebastian Wolfrum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.