Cardiac ArrestHACAinhospitalNCT00457431
Hypothermia After In-hospital Cardiac Arrest
A study testing Mild therapeutic hypothermia in people with Cardiac Arrest, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Mild therapeutic hypothermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteGermany
- Study dates
- 3 Apr 2007to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- in-hospital cardiac arrest
- restoration of spontanous circulation
- unconsciousness
- age over 18
- initiation of mild therapeutic hypothermia is possible within 4h after resuscitation
Who cannot join
- active bleeding
- suspicion of intra cranial bleeding
- severe infection
- aquired immun deficency
- severe rhythm disorders
- suspicion of cerebral insult
Show all 9Show fewer
- known severe cognotive deficit before the index event
- pregnancy
- pre existing disease which makes 6 months survival unlikely
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiac Arrest
- Being tested
- Mild therapeutic hypothermia
- Keywords
- in-hospital cardiac arrest, resuscitation, mild therapeutic hypothermia
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild therapeutic hypothermiaProcedure or surgery
Mild therapeutic hypothermia will be performed by any methods applicable in the hospitals
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard therapy as used in the hospital's ICU |
| Hypothermia | Active comparator | Standard therapy as used in the hospital's ICU plus Hypothermia Receives: Procedure: Mild therapeutic hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality at 6 months
Measured: 6 months
Secondary outcomes (2)
neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale
Measured: 6 months
in-hospital all cause mortality
Measured: time until discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study start3 Apr 2007
- Primary completion9 Nov 2014
- Study completion1 Mar 2021
Why it stopped: interim analysis with stopping for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hamburg-Eppendorf, University of Leipzig, University of Jena
- Responsible party
- Principal investigator, Sebastian Wolfrum, University Hospital Schleswig-Holstein
- Investigators
- Sebastian Wolfrum, MD, Principal investigator, University of Schleswig-Holstein, Campus Luebeck, Medical Clinic II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457431
- Sponsor's protocol ID
- HACA in-hospital
- Acronym
- HACAinhospital
- Status last verified
- Jun 2021
- First submitted
- 4 Apr 2007
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36168956Soar 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.
PubMed 17823147
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothermia After In-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00457431
- Acronym / sponsor ID
- HACAinhospital / HACA in-hospital
- Conditions
- Cardiac Arrest
- Keywords
- in-hospital cardiac arrest, resuscitation, mild therapeutic hypothermia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis with stopping for futility
- Enrolment
- 249 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- University of Hamburg-Eppendorf, University of Leipzig, University of Jena
- Study start
- 3 Apr 2007 (actual)
- Primary completion
- 9 Nov 2014 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 6 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard therapy as used in the hospital's ICU |
| Hypothermia | Active comparator | Procedure: Mild therapeutic hypothermiaStandard therapy as used in the hospital's ICU plus Hypothermia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- in-hospital cardiac arrest
- restoration of spontanous circulation
- unconsciousness
- age over 18
- initiation of mild therapeutic hypothermia is possible within 4h after resuscitation
Key exclusion criteria (9 listed)
- active bleeding
- suspicion of intra cranial bleeding
- severe infection
- aquired immun deficency
- severe rhythm disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mild therapeutic hypothermiaMild therapeutic hypothermia will be performed by any methods applicable in the hospitals | Procedure or surgery | Hypothermia |
Primary outcome
all cause mortality at 6 months
Time frame: 6 months
2 secondary outcomes
neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale
Time frame: 6 months
in-hospital all cause mortality
Time frame: time until discharge or death
Results and safety
The study was stopped early (reason given: interim analysis with stopping for futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Derived from this study: PubMed 36168956Wolfrum 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.
- Derived from this study: PubMed 17823147Soar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Wolfrum, MD principal investigator
University of Schleswig-Holstein, Campus Luebeck, Medical Clinic II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mild therapeutic hypothermia in people with Cardiac Arrest, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: interim analysis with stopping for futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00457431, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.