Cardiac ArrestNCT00676598
A Prospective Analysis of the Effect of Therapeutic Hypothermia After Cardiac Arrest
An observational study of Cardiac Arrest, run by Advocate Hospital System at 1 site in United States.
Trial summary
Therapeutic hypothermia has been shown to improve survival and neurologic outcome in patients resuscitated after ventricular fibrillation arrest. Few studies have examined whether therapeutic hypothermia is effective outside the research setting, or with other presenting rhythms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2010
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Any adult non-pregnant patient who is unresponsive after resuscitation from cardiac arrest regardless of presenting rhythm and who survives to hospital admission.
Who may be able to join
- Any adult non-pregnant patient who is unresponsive after resuscitation from cardiac arrest regardless of presenting rhythm and who survives to hospital admission.
Who cannot join
- hypotension (SBP <90), initial temperature < 30 °C, trauma, primary intracranial event, or active coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Therapeutic hypothermia has been shown to improve survival and neurologic outcome in patients resuscitated after ventricular fibrillation arrest.
Few studies have examined whether therapeutic hypothermia is effective outside the research setting, or with other presenting rhythms.
Our institution, a large community teaching hospital, instituted a therapeutic hypothermia protocol in November 2006 for all resuscitated cardiac arrest patients.
The investigators seek to determine the mortality rate of our protocol and compare our complication rates with those of previously published studies.
Read the detailed description
The use of therapeutic hypothermia has been shown to have a beneficial effect on neurologic outcomes of patients resuscitated from cardiac arrest in a limited number of clinical sites. Based on available data, current recommendations from the American Heart Association include a level 2a endorsement of therapeutic hypothermia for cardiac arrest from ventricular fibrillation with persistent coma, and a level 2b recommendation for cardiac arrest from any other rhythm. To date there have been no formal studies presented that demonstrate an improvement in outcome when a hypothermic protocol is implemented in a community hospital. The investigators plan to prospectively collect data on patients enrolled in the therapeutic hypothermia protocol to evaluate clinical outcomes and compare these outcomes with historic controls, with the hypothesis that patients enrolled in the hypothermic protocol will have improved neurologic outcomes.
- Conditions
- Cardiac Arrest
- Keywords
- therapeutic hypothermia
- Medical subject headings
- Heart Arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2010
- Study completionDec 2010
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advocate Hospital System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Kulstad, Advocate Hospital System
- Investigators
- Erik B Kulstad, MD,MS, Study chair, advocate christ medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676598
- Sponsor's protocol ID
- AHCIRB 4305
- Status last verified
- Jan 2012
- First submitted
- 12 May 2008
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of the Effect of Therapeutic Hypothermia After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00676598
- Acronym / sponsor ID
- AHCIRB 4305
- Conditions
- Cardiac Arrest
- Keywords
- therapeutic hypothermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Advocate Hospital SystemUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 May 2008 (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.
Therapeutic hypothermia has been shown to improve survival and neurologic outcome in patients resuscitated after ventricular fibrillation arrest.
Few studies have examined whether therapeutic hypothermia is effective outside the research setting, or with other presenting rhythms.
Our institution, a large community teaching hospital, instituted a therapeutic hypothermia protocol in November 2006 for all resuscitated cardiac arrest patients.
The investigators seek to determine the mortality rate of our protocol and compare our complication rates with those of previously published studies.
Detailed description
The use of therapeutic hypothermia has been shown to have a beneficial effect on neurologic outcomes of patients resuscitated from cardiac arrest in a limited number of clinical sites. Based on available data, current recommendations from the American Heart Association include a level 2a endorsement of therapeutic hypothermia for cardiac arrest from ventricular fibrillation with persistent coma, and a level 2b recommendation for cardiac arrest from any other rhythm. To date there have been no formal studies presented that demonstrate an improvement in outcome when a hypothermic protocol is implemented in a community hospital. The investigators plan to prospectively collect data on patients enrolled in the therapeutic hypothermia protocol to evaluate clinical outcomes and compare these outcomes with historic controls, with the hypothesis that patients enrolled in the hypothermic protocol will have improved neurologic outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult non-pregnant patient who is unresponsive after resuscitation from cardiac arrest regardless of presenting rhythm and who survives to hospital admission.
Key inclusion criteria (1 listed)
- Any adult non-pregnant patient who is unresponsive after resuscitation from cardiac arrest regardless of presenting rhythm and who survives to hospital admission.
Key exclusion criteria (1 listed)
- hypotension (SBP <90), initial temperature < 30 °C, trauma, primary intracranial event, or active coagulopathy.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
Related trials for Cardiac Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
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.
Erik B Kulstad, MD,MS study chair
advocate christ medical center
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, run by Advocate Hospital System at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 6 Jan 2012. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 6 Jan 2012.