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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836302
• Other study ID #: B2011:138
• Status: Completed
• Phase: N/A
• First received: April 16, 2013
• Last updated: December 6, 2013
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Over 18

• Diagnosis of septic shock

• Require mechanical ventilation and vasopressor therapy

Exclusion Criteria:

• Previous stroke

• Dementia

• Recent Craniotomy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium
• Renal Failure
• Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• Observation

Locations

Country	Name	City	State
Canada	Health Sciences Center	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Renal Failure	Defined using RIFLE Criteria	28 Days	No
Primary	Incidence of Delirium		28 Days	No
Secondary	Death		28 Days	No