Hypothermia After In-hospital Cardiac Arrest (HACAinhospital)
Primary Purpose
Cardiac Arrest
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mild therapeutic hypothermia
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest focused on measuring in-hospital cardiac arrest, resuscitation, mild therapeutic hypothermia
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
Sites / Locations
- Sebastian Wolfrum
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Hypothermia
Arm Description
Standard therapy as used in the hospital's ICU
Standard therapy as used in the hospital's ICU plus Hypothermia
Outcomes
Primary Outcome Measures
all cause mortality at 6 months
Secondary Outcome Measures
neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale
in-hospital all cause mortality
Full Information
NCT ID
NCT00457431
First Posted
April 4, 2007
Last Updated
June 15, 2021
Sponsor
University Hospital Schleswig-Holstein
Collaborators
University of Hamburg-Eppendorf, University of Leipzig, University of Jena
1. Study Identification
Unique Protocol Identification Number
NCT00457431
Brief Title
Hypothermia After In-hospital Cardiac Arrest
Acronym
HACAinhospital
Official Title
Hypothermia After In-hospital Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
interim analysis with stopping for futility
Study Start Date
April 3, 2007 (Actual)
Primary Completion Date
November 9, 2014 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
Collaborators
University of Hamburg-Eppendorf, University of Leipzig, University of Jena
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
in-hospital cardiac arrest, resuscitation, mild therapeutic hypothermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard therapy as used in the hospital's ICU
Arm Title
Hypothermia
Arm Type
Active Comparator
Arm Description
Standard therapy as used in the hospital's ICU plus Hypothermia
Intervention Type
Procedure
Intervention Name(s)
Mild therapeutic hypothermia
Intervention Description
Mild therapeutic hypothermia will be performed by any methods applicable in the hospitals
Primary Outcome Measure Information:
Title
all cause mortality at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale
Time Frame
6 months
Title
in-hospital all cause mortality
Time Frame
time until discharge or death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Wolfrum, MD
Organizational Affiliation
University of Schleswig-Holstein, Campus Luebeck, Medical Clinic II
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sebastian Wolfrum
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
36168956
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.
Results Reference
derived
PubMed Identifier
17823147
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.
Results Reference
derived
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Hypothermia After In-hospital Cardiac Arrest
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