Hypothermia After In-hospital Cardiac Arrest (HACAinhospital)

June 15, 2021 updated by: Sebastian Wolfrum, University Hospital Schleswig-Holstein
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

249

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Sebastian Wolfrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause mortality at 6 months
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Collaborators

University of Leipzig
University of Jena
University of Hamburg-Eppendorf

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2007

Primary Completion (Actual)

November 9, 2014

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 6, 2007

Study Record Updates

Last Update Posted (Actual)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HACA in-hospital

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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