Hypothermia After In-hospital Cardiac Arrest (HACAinhospital)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Cardiac Arrest	Procedure: Mild therapeutic hypothermia	Not Applicable

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	440 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Hypothermia After In-hospital Cardiac Arrest
Study Start Date :	April 2007
Estimated Primary Completion Date :	April 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
No Intervention: Control; Standard therapy as used in the hospital's ICU
Active Comparator: Hypothermia; Standard therapy as used in the hospital's ICU plus Hypothermia	Procedure: Mild therapeutic hypothermia; Mild therapeutic hypothermia will be performed by any methods applicable in the hospitals

Outcome Measures

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Primary Outcome Measures :

1. all cause mortality at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale [ Time Frame: 6 months ]
2. in-hospital all cause mortality [ Time Frame: time until discharge or death ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Sebastian Wolfrum, MD	+49451500 ext 2501	wolfrum@medinf.mu-luebeck.de
Contact: Volkhard Kurowski, MD	+49451500 ext 2330

Locations

Germany
University of Schleswig-Holstein, Campus Lübeck, Medical Clinic II	Recruiting
Lübeck, Germany, 23538
Contact: Sebastian Wolfrum, MD +49451500 ext 2501 swolfrum@online.de
Principal Investigator: Sebastian Wolfrum, MD

Sponsors and Collaborators

University of Schleswig-Holstein

University of Hamburg

University of Leipzig

University of Jena

Investigators

Principal Investigator:	Sebastian Wolfrum, MD	University of Schleswig-Holstein, Campus Luebeck, Medical Clinic II

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Responsible Party:	Sebastian Wolfrum, D. Sebastian Wolfrum, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT00457431 History of Changes
Other Study ID Numbers:	HACA in-hospital
First Posted:	April 6, 2007
Last Update Posted:	June 15, 2015
Last Verified:	June 2015

Keywords provided by Sebastian Wolfrum, University of Schleswig-Holstein:

in-hospital cardiac arrest; resuscitation; mild therapeutic hypothermia

Additional relevant MeSH terms:

Heart Arrest; Hypothermia; Heart Diseases	Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms