Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study

Terminated

• Conditions: Septic Shock

• Registration Number: NCT02237833
• Lead Sponsor: Karl-Andre Wian

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.

Study Timeline

• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-11
• Study Start: 2015-02
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of acute myocardial infarction	Hospital discharge, expected 12 days at average	Incidence of acute myocardial infarction based on international criteria
Use of vasopressors/inotropes	Discharge from ICU, expected 5 days at average	Use of vasopressors/inotropes; * norepinephrine; * epinephrine; * dopamine; * dobutamine; * vasopressin; * nitroprusside; * glyceryltrinitrate
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	Measuring Sequential Organ Failure Assessment, SOFA, score at inclusion and once daily during ICU-stay.
Fluid balance	24 hours
Length of stay in hospital	Discharge from hospital, expected 10 days at average

Trial Locations

Locations (1)

Sykehuset i Vestfold HF; 🇳🇴 Tonsberg, Vestfold, Norway