Cardiac ArrestNCT01083069
Follow up After Survived Therapy With Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation (ROSC)
An observational study of Cardiac Arrest and Hypothermia, run by University of Leipzig at 1 site in Germany.
Trial summary
Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest, Hypothermia
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jun 2011
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients after restoration of spontaneous circulation
Who may be able to join
- survived cardiac arrest
- voluntary consent
Who cannot join
- no voluntary consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Leipzig, Heart Center, Cardiology
Leipzig
Undine Pittl, MD, 0049-341-8651427, undine.pittl@gmail.com
Holger Thiele, Associate Professor, 0049-341-8651427, thielh@med.uni-leipzig.de
About this study
Official title: Neurological Outcome After Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation
Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the long term neurological outcome after mild hypothermia after restoration of spontaneous circulation.
Read the detailed description
Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC).
- Conditions
- Cardiac Arrest, Hypothermia
- Keywords
- Sudden cardiac arrest, hypothermia, neurological outcome
- Medical subject headings
- Heart Arrest, Hypothermia, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COOL | Patients after therapy with mild hypothermia | |
| UnCool | Patients without therapy with mild hypothermia due to non-operational cooling-devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcome after 6 month after MIH, Quality of life-survey
Neurological outcome after 6 month after MIH measured by questionnaire.
Measured: 6 Month
Secondary outcomes (4)
Managing daily activities
Managing daily activities after 6 month after tMIH measured with a questionnaire.
Measured: 6 Month
Surviving after hospitalization
Surviving after hospitalization after MIH
Measured: 6 Month
Neurological outcome depending of the beginning of MIH
Neurological outcome depending of the beginning of MIH
Measured: 6 month
Neurological Outcome in consideration of the practice of the treating instances.
Neurological outcome in consideration of the practice of the treating instances after restoration of spontanous circulation measured with a questionnaire.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Investigators
- Holger Thiele, Associate Professor, Principal investigator, Study ChairUndine Pittl, MD, Study director, Study Sub-invesigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083069
- Sponsor's protocol ID
- Cool-Trial Follow up
- Status last verified
- Jan 2010
- First submitted
- 25 Feb 2010
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Outcome After Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation
- ClinicalTrials.gov ID
- NCT01083069
- Acronym / sponsor ID
- Cool-Trial Follow up
- Conditions
- Cardiac Arrest, Hypothermia
- Keywords
- Sudden cardiac arrest, hypothermia, neurological outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 9 Mar 2010 (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.
Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the long term neurological outcome after mild hypothermia after restoration of spontaneous circulation.
Detailed description
Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COOL | – | –Patients after therapy with mild hypothermia |
| UnCool | – | –Patients without therapy with mild hypothermia due to non-operational cooling-devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after restoration of spontaneous circulation
Key inclusion criteria (2 listed)
- survived cardiac arrest
- voluntary consent
Key exclusion criteria (1 listed)
- no voluntary consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurological outcome after 6 month after MIH, Quality of life-survey
Time frame: 6 Month
Neurological outcome after 6 month after MIH measured by questionnaire.
4 secondary outcomes
Managing daily activities
Time frame: 6 Month
Surviving after hospitalization
Time frame: 6 Month
Neurological outcome depending of the beginning of MIH
Time frame: 6 month
Neurological Outcome in consideration of the practice of the treating instances.
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
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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.
Holger Thiele, Associate Professor principal investigator
Study Chair
Undine Pittl, MD study director
Study Sub-invesigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Hypothermia, run by University of Leipzig 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Mar 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Undine Pittl, MD (0049-341-8651427, undine.pittl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological outcome after 6 month after MIH, Quality of life-survey (time frame: 6 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2010.