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

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.

Study Overview

• Status: Completed
• Conditions: Delirium; Septic Shock; Renal Failure
• Intervention / Treatment: Other: Observation

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A1R9
      • Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients admitted to the Intensive Care Unit with Septic Shock

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Previous stroke
• Dementia
• Recent Craniotomy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Cerebral Desaturation; We will compare the primary and secondary outcomes between the patients who experience cerebral desaturations and those that do not.	Other: Observation
Patients without cerebral desaturation; We will compare the primary and secondary outcomes between the patients who experience cerebral desaturations and those that do not.	Other: Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Delirium	28 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Death	28 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal Failure	Defined using RIFLE Criteria	28 Days

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 16, 2013
• First Submitted That Met QC Criteria: April 18, 2013
• First Posted (Estimate): April 19, 2013

Study Record Updates

• Last Update Posted (Estimate): December 10, 2013
• Last Update Submitted That Met QC Criteria: December 6, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Sepsis; Delirium; Shock, Septic; Shock
• Other Study ID Numbers: B2011:138