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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01836302
First Posted: April 19, 2013
Last Update Posted: December 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Duane Funk, University of Manitoba
  Purpose

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.


Condition Intervention
Septic Shock Delirium Renal Failure Other: Observation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Septic Shock and Delirium Because of rSO2 Abnormalities in Intensive Care Unit Patients (The SAD BRAIN Study)

Resource links provided by NLM:


Further study details as provided by Dr. Duane Funk, University of Manitoba:

Primary Outcome Measures:
  • Incidence of Delirium [ Time Frame: 28 Days ]

Secondary Outcome Measures:
  • Death [ Time Frame: 28 Days ]

Other Outcome Measures:
  • Renal Failure [ Time Frame: 28 Days ]
    Defined using RIFLE Criteria


Enrollment: 16
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients admitted to the Intensive Care Unit with Septic Shock
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous stroke
  • Dementia
  • Recent Craniotomy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836302


Locations
Canada, Manitoba
Health Sciences Center
Winnipeg, Manitoba, Canada, R3A1R9
Sponsors and Collaborators
University of Manitoba
  More Information

Responsible Party: Dr. Duane Funk, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01836302     History of Changes
Other Study ID Numbers: B2011:138
First Submitted: April 16, 2013
First Posted: April 19, 2013
Last Update Posted: December 10, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Shock
Delirium
Renal Insufficiency
Shock, Septic
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Kidney Diseases
Urologic Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation


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