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Completed

NCT Number: NCT01836302

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences Center

Winnipeg, Manitoba, R3A1R9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous stroke
  • Dementia
  • Recent Craniotomy

Treatment and study plan

observation

Other

Primary outcomes

  1. Incidence of Delirium

    Time frame: 28 Days

Secondary outcomes

  1. Death

    Time frame: 28 Days

Other outcomes

  1. Renal Failure

    Time frame: 28 Days

    Defined using RIFLE Criteria

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2013
Registry last updated
Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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