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

December 6, 2013 updated by: Dr. Duane Funk, University of Manitoba

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 28 Days
28 Days

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • B2011:138

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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