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

Primary Purpose

Cerebral Metabolism and Perfusion

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
mild hypo- and hyperventilation
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cerebral Metabolism and Perfusion focused on measuring Cerebral metabolism, perfusion, induced hypothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Critical Care Medicine Research Group/ department of intensive care

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

crossover: hypo- and hypercarbia

Arm Description

Outcomes

Primary Outcome Measures

surrogate physiological endpoints

Secondary Outcome Measures

Full Information

First Posted
October 2, 2008
Last Updated
October 19, 2016
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00766103
Brief Title
The Effects of PaCO2 Levels on Cerebral Metabolism and Perfusion During Induced Hypothermia.
Official Title
The Effects of PaCO2 Levels on Cerebral Metabolism and Perfusion During Induced Hypothermia.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Metabolism and Perfusion
Keywords
Cerebral metabolism, perfusion, induced hypothermia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
crossover: hypo- and hypercarbia
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
mild hypo- and hyperventilation
Intervention Description
induction of mild hypo- and hypercarbia
Primary Outcome Measure Information:
Title
surrogate physiological endpoints
Time Frame
60minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Critical Care Medicine Research Group/ department of intensive care
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33521
Country
Finland

12. IPD Sharing Statement

Links:
URL
http://www.pshp.fi/default.aspx?contentlan=2
Description
Tampere University Hospital (Pirkanmaa hospital district) home page (in English)

Learn more about this trial

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

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