Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study (CONSCIOUS)

Cerebral Oxygenation in Septic Patients Using Vasopressors - The Conscious Study

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.

Study Overview

• Status: Terminated
• Conditions: Septic Shock

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Norway
  • Vestfold
    • Tonsberg, Vestfold, Norway, N-3117
      • Sykehuset i Vestfold HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients in the intensive care unit needing vasopressor for septic shock.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Septic shock and vasopressor; Measuring cerebral oxymetry (SCO2) first 24 hours in septic shock and given vasopressors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of acute myocardial infarction	Incidence of acute myocardial infarction based on international criteria	Hospital discharge, expected 12 days at average
Use of vasopressors/inotropes	Use of vasopressors/inotropes; norepinephrine; epinephrine; dopamine; dobutamine; vasopressin; nitroprusside; glyceryltrinitrate	Discharge from ICU, expected 5 days at average
Fluid balance		24 hours
Length of stay in ICU		Discharge from ICU, expected 5 days at average
Length of stay in hospital		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.	Discharge from ICU, expected 5 days at average

Collaborators and Investigators

• Sponsor: Karl-Andre Wian
• Investigators: Principal Investigator: Karl-Andre Wian, cand.med., Syekhuset Vestfold HF

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: September 8, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: septic shock; norepinephrine; cerebral oximetry; vasopressor
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: 2014/194 REK