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Clinical Trials/NCT02237833
NCT02237833
Terminated
Not Applicable

Cerebral Oxygenation in Septic Patients Using Vasopressors - The Conscious Study

Karl-Andre Wian1 site in 1 country15 target enrollmentFebruary 2015
ConditionsSeptic Shock

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Septic Shock
Sponsor
Karl-Andre Wian
Enrollment
15
Locations
1
Primary Endpoint
Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
January 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Karl-Andre Wian
Responsible Party
Sponsor Investigator
Principal Investigator

Karl-Andre Wian

MD

Sykehuset i Vestfold HF

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours

Time Frame: 24 hours

SCO2 will be measured before initiating vasopressor therapy. Thereafter SCO2 are updated every 2 seconds and is measured for 24 hours.

Secondary Outcomes

  • Incidence of acute myocardial infarction(Hospital discharge, expected 12 days at average)
  • Use of vasopressors/inotropes(Discharge from ICU, expected 5 days at average)
  • Length of stay in ICU(Discharge from ICU, expected 5 days at average)
  • Incidence of organ failure(Discharge from ICU, expected 5 days at average)
  • Fluid balance(24 hours)
  • Length of stay in hospital(Discharge from hospital, expected 10 days at average)

Study Sites (1)

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