Hypothermia After In-hospital Cardiac Arrest (HACAinhospital)

• ClinicalTrials.gov Identifier: NCT00457431
• Recruitment Status: Terminated
• First Posted: April 6, 2007
• Last Update Posted: June 22, 2021
• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: University of Hamburg-Eppendorf; University of Leipzig; University of Jena
• Information provided by (Responsible Party): Sebastian Wolfrum, University Hospital Schleswig-Holstein

Study Description

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 249 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Hypothermia After In-hospital Cardiac Arrest
• Actual Study Start Date: April 3, 2007
• Actual Primary Completion Date: November 9, 2014
• Actual Study Completion Date: March 1, 2021

Arms and Interventions

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

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Locations

Germany

Sebastian Wolfrum

Lübeck, Schleswig-Holstein, Germany, 23538

Sponsors and Collaborators

University Hospital Schleswig-Holstein

University of Hamburg-Eppendorf

University of Leipzig

University of Jena

Investigators

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

More Information

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

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.

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.

• Responsible Party: Sebastian Wolfrum, D. Sebastian Wolfrum, University Hospital Schleswig-Holstein
• ClinicalTrials.gov Identifier: NCT00457431
• Other Study ID Numbers: HACA in-hospital
• First Posted: April 6, 2007
• Last Update Posted: June 22, 2021
• Last Verified: June 2021

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

in-hospital cardiac arrest; resuscitation; mild therapeutic hypothermia

Additional relevant MeSH terms:

Heart Arrest; Hypothermia; Heart Diseases; Cardiovascular Diseases; Body Temperature Changes