Septic Shock and Delirium Because of rSO2 Abnormalities in Intensive Care Unit Patients (The SAD BRAIN Study)

Completed

• Conditions: Septic Shock; Delirium; Renal Failure

• Registration Number: NCT01836302
• Lead Sponsor: University of Manitoba

Brief Summary

Delirium in the ICU is a prevalent problem occurring in up to 80% of ICU patients. A potential cause of delirium in ICU patients could be cerebral hypoxia. Septic shock is associated with high rates of delirium.

The aim of this pilot study is two fold. First, to determine the feasibility and potential challenges of measuring cerebral oxygenation in ICU patients with severe sepsis and septic shock. And second, to see if the incidence and magnitude of cerebral desaturations correlated with ICU acquired delirium as measured by the Confusion Assessment Method (CAM) scores.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-04-16
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-19
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-06
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Over 18
• Diagnosis of septic shock
• Require mechanical ventilation and vasopressor therapy

Exclusion Criteria

• Previous stroke
• Dementia
• Recent Craniotomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Delirium	28 Days

Secondary Outcome Measures

Name	Time	Method
Death	28 Days

Trial Locations

Locations (1)

Health Sciences Center; 🇨🇦 Winnipeg, Manitoba, Canada