- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00766103
The Effects of PaCO2 Levels on Cerebral Metabolism and Perfusion During Induced Hypothermia.
October 19, 2016 updated by: Patrik Falkenbach, Tampere University Hospital
Incidence of hypo- and hypercarbia during induced hypothermia after cardiac arrest is high.
The original report from HACA-group reported that hypothermia treated patients had improved survival and neurological outcome.
Suprisingly, in that trial normocarbia was not achieved even though the aim was set for ventilatory support as normoventilation.
This study aims to investigate the effects of mild hypo- and hypercarbia on cerebral perfusion (blood flow, intracranial pressure) and metabolism (microdialysate metabolites).
We hypothesize that uncontrolled ventilatory suppport may render the patients in risk of exacerbation of neuronal damage, conversely, further improvement in outcome may be achieved with succesfull ventilatory management.
We intend to enroll 10 out-of-hospital cardiac arrest patients succesfully resuscitated and subsequently treated with controlled hypothermia for 24 hours.
The patients in need of anticoagulation are excluded.
We plan to induce mild hypocarbia and hypercarbia during and after induced hypothermia.
Metabolic and perfusion data are collected with clinically used methods such as transcranial doppler, intracranial pressure measurement, near infrared spectroscopy, jugular bulb, intracerebral microdialysis).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pirkanmaa
-
Tampere, Pirkanmaa, Finland, 33521
- Critical Care Medicine Research Group/ department of intensive care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
succesfull resuscitation of out of hospital cardiac arrest, primary rhytm shockable
Exclusion Criteria:
- known coagulopathy, need of anticoagulation therapy, need of interventional cardiological procedures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: crossover: hypo- and hypercarbia
|
induction of mild hypo- and hypercarbia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
surrogate physiological endpoints
Time Frame: 60minutes
|
60minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
October 2, 2008
First Submitted That Met QC Criteria
October 2, 2008
First Posted (Estimate)
October 3, 2008
Study Record Updates
Last Update Posted (Estimate)
October 21, 2016
Last Update Submitted That Met QC Criteria
October 19, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R06213
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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