Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01836302
Enrollment
16
Registered
2013-04-19
Start date
2012-08-31
Completion date
2013-12-31
Last updated
2013-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Renal Failure, Septic Shock

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.

Interventions

OTHERObservation

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Previous stroke * Dementia * Recent Craniotomy

Design outcomes

Primary

MeasureTime frame
Incidence of Delirium28 Days

Secondary

MeasureTime frame
Death28 Days

Other

MeasureTime frameDescription
Renal Failure28 DaysDefined using RIFLE Criteria

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026