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

NCT ID: NCT01836302

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Septic Shock Delirium Renal Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Cerebral Desaturation

We will compare the primary and secondary outcomes between the patients who experience cerebral desaturations and those that do not.

Observation

Intervention Type OTHER

Patients without cerebral desaturation

We will compare the primary and secondary outcomes between the patients who experience cerebral desaturations and those that do not.

Observation

Intervention Type OTHER

Interventions

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Observation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previous stroke
* Dementia
* Recent Craniotomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Duane Funk

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Health Sciences Center

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2011:138

Identifier Type: -

Identifier Source: org_study_id