Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study

Karl-Andre Wian15 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Septic Shock

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sykehuset i Vestfold HF

Tønsberg, Vestfold, Norway

Outcomes

Primary Outcomes

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

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

Time frame: 24 hours

Secondary Outcomes

Incidence of acute myocardial infarction

Incidence of acute myocardial infarction based on international criteria

Time frame: Hospital discharge, expected 12 days at average

Use of vasopressors/inotropes

Use of vasopressors/inotropes * norepinephrine * epinephrine * dopamine * dobutamine * vasopressin * nitroprusside * glyceryltrinitrate

Time frame: Discharge from ICU, expected 5 days at average

Fluid balance

Time frame: 24 hours

Length of stay in ICU

Time frame: Discharge from ICU, expected 5 days at average

Length of stay in hospital

Time frame: Discharge from hospital, expected 10 days at average

Incidence of organ failure

Measuring Sequential Organ Failure Assessment, SOFA, score at inclusion and once daily during ICU-stay.

Time frame: Discharge from ICU, expected 5 days at average

Data from ClinicalTrials.gov

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