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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00766103
Other study ID # R06213
Secondary ID
Status Completed
Phase N/A
First received October 2, 2008
Last updated October 19, 2016
Start date December 2006
Est. completion date May 2008

Study information

Verified date October 2016
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ministry of health
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
mild hypo- and hyperventilation
induction of mild hypo- and hypercarbia

Locations

Country Name City State
Finland Critical Care Medicine Research Group/ department of intensive care Tampere Pirkanmaa

Sponsors (1)

Lead Sponsor Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary surrogate physiological endpoints 60minutes No