Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study

Septic Shock Clinical Trial

— CONSCIOUS  

Official title:

Cerebral Oxygenation in Septic Patients Using Vasopressors - The Conscious Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02237833
• Other study ID #: 2014/194 REK
• Status: Terminated
• Phase: N/A
• First received: September 8, 2014
• Last updated: April 26, 2017
• Start date: February 2015
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Locations

Country	Name	City	State
Norway	Sykehuset i Vestfold HF	Tonsberg	Vestfold

Sponsors (1)

Lead Sponsor	Collaborator
Karl-Andre Wian

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of acute myocardial infarction	Incidence of acute myocardial infarction based on international criteria	Hospital discharge, expected 12 days at average
Secondary	Use of vasopressors/inotropes	Use of vasopressors/inotropes; norepinephrine; epinephrine; dopamine; dobutamine; vasopressin; nitroprusside; glyceryltrinitrate	Discharge from ICU, expected 5 days at average
Secondary	Fluid balance		24 hours
Secondary	Length of stay in ICU		Discharge from ICU, expected 5 days at average
Secondary	Length of stay in hospital		Discharge from hospital, expected 10 days at average
Secondary	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