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The Effects of PaCO2 Levels on Cerebral Metabolism and Perfusion During Induced Hypothermia.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00766103
First Posted: October 3, 2008
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patrik Falkenbach, Tampere University Hospital
  Purpose
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).

Condition Intervention
Cerebral Metabolism and Perfusion Other: mild hypo- and hyperventilation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effects of PaCO2 Levels on Cerebral Metabolism and Perfusion During Induced Hypothermia.

Resource links provided by NLM:


Further study details as provided by Patrik Falkenbach, Tampere University Hospital:

Primary Outcome Measures:
  • surrogate physiological endpoints [ Time Frame: 60minutes ]

Enrollment: 8
Study Start Date: December 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
crossover: hypo- and hypercarbia Other: mild hypo- and hyperventilation
induction of mild hypo- and hypercarbia

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766103


Locations
Finland
Critical Care Medicine Research Group/ department of intensive care
Tampere, Pirkanmaa, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
  More Information

Additional Information:
Responsible Party: Patrik Falkenbach, Md, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT00766103     History of Changes
Other Study ID Numbers: R06213
First Submitted: October 2, 2008
First Posted: October 3, 2008
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Patrik Falkenbach, Tampere University Hospital:
Cerebral metabolism, perfusion, induced hypothermia

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms