Clinical trial NCT02237833: Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study
Official title: Cerebral Oxygenation in Septic Patients Using Vasopressors - The Conscious Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Septic Shock
Keywords: septic shock
cerebral oximetry
vasopressor
norepinephrine
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in the intensive care unit needing vasopressor for septic shock.

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.

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

Primary outcomes:
measure: Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Incidence of acute myocardial infarction
timeFrame: Hospital discharge, expected 12 days at average
measure: Use of vasopressors/inotropes
timeFrame: Discharge from ICU, expected 5 days at average
measure: Fluid balance
timeFrame: 24 hours
measure: Length of stay in ICU
timeFrame: Discharge from ICU, expected 5 days at average
measure: Length of stay in hospital
timeFrame: Discharge from hospital, expected 10 days at average
measure: Incidence of organ failure
timeFrame: Discharge from ICU, expected 5 days at average
Other outcomes:
Locations:
city: Tonsberg
country: Norway
facility: Sykehuset i Vestfold HF
state: Vestfold
Study officials:
affiliation: Syekhuset Vestfold HF
name: Karl-Andre Wian, cand.med.
role: PRINCIPAL_INVESTIGATOR
References: