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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Duane Funk, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01836302
First received: April 16, 2013
Last updated: December 6, 2013
Last verified: December 2013
  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 University of Manitoba:

Primary Outcome Measures:
  • Incidence of Delirium [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Renal Failure [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836302

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

No publications provided

Responsible Party: Dr. Duane Funk, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01836302     History of Changes
Other Study ID Numbers: B2011:138
Study First Received: April 16, 2013
Last Updated: December 6, 2013
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on October 16, 2014