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NCT01836302 Clinical Trial

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
Secondary ID
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

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
See also
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