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

NCT01836302 | Completed

• 1 other identifier: B2011:138
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Delirium; Renal Failure

Outcome Measures

Primary Outcomes (1)

• Incidence of Delirium

  28 Days

Secondary Outcomes (1)

• Death

  28 Days

Other Outcomes (1)

• Renal Failure

  28 Days

Study Arms (2)

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

Interventions

Observation OTHER

Patients with Cerebral Desaturation; Patients without cerebral desaturation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients admitted to the Intensive Care Unit with Septic Shock

You may qualify if:

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

You may not qualify if:

• Previous stroke
• Dementia
• Recent Craniotomy

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Center

Winnipeg, Manitoba, R3A1R9, Canada

Location

MeSH Terms

Conditions

Shock, Septic; Delirium; Renal Insufficiency

Interventions

Observation

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 19, 2013
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

CA (1)