Cardiac ArrestNCT00441753
Cerebral Bloodflow and Carbondioxide Reactivity During Mild Therapeutic Hypothermia in Patients After Cardiac Arrest
An observational study of Cardiac Arrest and Post-Anoxic Encephalopathy, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Survivors of a cardiac arrest frequently develop severe postanoxic encephalopathy. Derangements in cerebral blood after return of spontaneous circulation play an important role in the pathogenesis of postanoxic encephalopathy. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cardiac Arrest, Post-Anoxic Encephalopathy
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2006to not given
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after cardiac arrest, comatose and treated with therapeutic hypothermia
Who may be able to join
- adult patients
- GCS after return of circulation < 7
- Induced mild hypothermia for 24 hours
- primary rhythm ventricular fibrillation
Who cannot join
- Thrombolysis
- Cardiogenic shock with expected survival < 24 hrs
- Pregnancy
- No informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
Cornelia Hoedemaekers, MD PhD, 00.31.24.3617273, C.Hoedemaekers@ic.umcn.nl
Koen Simons, MD
About this study
Survivors of a cardiac arrest frequently develop severe postanoxic encephalopathy. Derangements in cerebral blood after return of spontaneous circulation play an important role in the pathogenesis of postanoxic encephalopathy. In the present study we examine the effect of mild therapeutic hypothermia on cerebral blood flow and carbondioxide reactivity in patients after cardiac arrest.
- Conditions
- Cardiac Arrest, Post-Anoxic Encephalopathy
- 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 posted1 Mar 2007 (estimated)
- Study startSep 2006
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.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Cornelia Hoedemaekers, MD PhD, Principal investigator, Radboud University Medical CenterJohannes van der Hoeven, MD PhD, Study director, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441753
- Sponsor's protocol ID
- KSCH0601
- Status last verified
- Feb 2009
- First submitted
- 28 Feb 2007
- Last updated
- 6 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Bloodflow and Carbondioxide Reactivity During Mild Therapeutic Hypothermia in Patients After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00441753
- Acronym / sponsor ID
- KSCH0601
- Conditions
- Cardiac Arrest, Post-Anoxic Encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Sep 2006
- First posted
- 1 Mar 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.
Survivors of a cardiac arrest frequently develop severe postanoxic encephalopathy. Derangements in cerebral blood after return of spontaneous circulation play an important role in the pathogenesis of postanoxic encephalopathy. In the present study we examine the effect of mild therapeutic hypothermia on cerebral blood flow and carbondioxide reactivity in patients after cardiac arrest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after cardiac arrest, comatose and treated with therapeutic hypothermia
Key inclusion criteria (4 listed)
- adult patients
- GCS after return of circulation < 7
- Induced mild hypothermia for 24 hours
- primary rhythm ventricular fibrillation
Key exclusion criteria (4 listed)
- Thrombolysis
- Cardiogenic shock with expected survival < 24 hrs
- Pregnancy
- No informed 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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
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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.
Cornelia Hoedemaekers, MD PhD principal investigator
Radboud University Medical Center
Johannes van der Hoeven, MD PhD study director
Radboud University 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 and Post-Anoxic Encephalopathy, run by Radboud University Medical Center at 1 site in Netherlands.
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 4 inclusion and 4 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 6 Feb 2009. 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 Netherlands. 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 Cornelia Hoedemaekers, MD PhD (00.31.24.3617273, C.Hoedemaekers@ic.umcn.nl), or a site near the patient. 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 Feb 2009.