Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study

NCT ID: NCT02237833

Last Updated: 2017-04-27

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

TERMINATED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-01-31

Brief Summary

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The purpose of this study is to reveal if higher doses of vasopressors in septic shock patients correlates with cerebral vasoconstriction and lower cerebral oximetry.

Detailed Description

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The mortality with septic shock is high. Treatment includes antibiotics, intravenous fluid and drugs for circulatory support, especially the vasopressor norepinephrine. Fluids and drugs for circulatory support are to restore adequate organ perfusion. Inadequate oxygenation of the brain can give neurologic damage. Traditionally treatment is guided by surrogate markers like arterial and central venous pressure. Cerebral oximetry is a non-invasive method which measures cerebral saturation of oxygen, SCO2, and thereby expresses regional cerebral perfusion. By registering cerebral oxymetry on patients treated with vasopressors for septic shock we want to reveal if higher doses of vasopressor correlates with cerebral vasoconstriction and lower cerebral oximetry.

Conditions

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Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Septic shock and vasopressor

Measuring cerebral oxymetry (SCO2) first 24 hours in septic shock and given vasopressors.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Septic shock patients in ICU department requiring vasopressor therapy

Exclusion Criteria

* Damage to the frontal lobes corresponding to the area where SCO2 is monitored
* Patients in pharmacological studies
* Patients with known intracranial vascular anomalies or cerebral aneurysms
* Patients where vasoactive medication is started before cerebral oxymetry is established
* Patients with known neurological disease
* Patients with undergone cerebral insult, transient ischemic attack or carotid stenosis
* Patients who have been resuscitated after cardiac arrest in connection with this hospital stay
* Patients with a body temperature below 35 degrees Celsius when establishing monitoring
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karl-Andre Wian

OTHER

Sponsor Role lead

Responsible Party

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Karl-Andre Wian

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Karl-Andre Wian, cand.med.

Role: PRINCIPAL_INVESTIGATOR

Syekhuset Vestfold HF

Locations

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Sykehuset i Vestfold HF

Tønsberg, Vestfold, Norway

Site Status

Countries

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Norway

Other Identifiers

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2014/194 REK

Identifier Type: -

Identifier Source: org_study_id

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