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

NCT ID: NCT00766103

Last Updated: 2016-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Cerebral Metabolism and Perfusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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crossover: hypo- and hypercarbia

Group Type OTHER

mild hypo- and hyperventilation

Intervention Type OTHER

induction of mild hypo- and hypercarbia

Interventions

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mild hypo- and hyperventilation

induction of mild hypo- and hypercarbia

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Patrik Falkenbach

Md

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Critical Care Medicine Research Group/ department of intensive care

Tampere, Pirkanmaa, Finland

Site Status

Countries

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Finland

Related Links

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http://www.pshp.fi/default.aspx?contentlan=2

Tampere University Hospital (Pirkanmaa hospital district) home page (in English)

http://www.pshp.fi/default.aspx?nodeid=10066&contentlan=1

Home page of the Science Center of Tampere University Hospital (in Finnish)

Other Identifiers

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R06213

Identifier Type: -

Identifier Source: org_study_id

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