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Hypothermia After In-hospital Cardiac Arrest

Hypothermia After In-hospital Cardiac Arrest

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00457431
Acronym
HACAinhospital
Enrollment
249
Registered
2007-04-06
Start date
2007-04-03
Completion date
2021-03-01
Last updated
2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

in-hospital cardiac arrest, resuscitation, mild therapeutic hypothermia

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.

Interventions

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

Sponsors

University of Hamburg-Eppendorf
CollaboratorOTHER
University of Leipzig
CollaboratorOTHER
University of Jena
CollaboratorOTHER
University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
all cause mortality at 6 months6 months

Secondary

MeasureTime frame
neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale6 months
in-hospital all cause mortalitytime until discharge or death

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026