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Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study

Cerebral Oxygenation in Septic Patients Using Vasopressors - The Conscious Study

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02237833
Acronym
CONSCIOUS
Enrollment
15
Registered
2014-09-11
Start date
2015-02-28
Completion date
2017-01-31
Last updated
2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

septic shock, cerebral oximetry, vasopressor, norepinephrine

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.

Interventions

None listed

Sponsors

Karl-Andre Wian
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours24 hoursSCO2 will be measured before initiating vasopressor therapy. Thereafter SCO2 are updated every 2 seconds and is measured for 24 hours.

Secondary

MeasureTime frameDescription
Use of vasopressors/inotropesDischarge from ICU, expected 5 days at averageUse of vasopressors/inotropes * norepinephrine * epinephrine * dopamine * dobutamine * vasopressin * nitroprusside * glyceryltrinitrate
Fluid balance24 hours
Incidence of acute myocardial infarctionHospital discharge, expected 12 days at averageIncidence of acute myocardial infarction based on international criteria
Length of stay in hospitalDischarge from hospital, expected 10 days at average
Incidence of organ failureDischarge from ICU, expected 5 days at averageMeasuring Sequential Organ Failure Assessment, SOFA, score at inclusion and once daily during ICU-stay.
Length of stay in ICUDischarge from ICU, expected 5 days at average

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026