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Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)

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ClinicalTrials.gov Identifier: NCT03015584
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
University of Utah
Information provided by (Responsible Party):
Samuel Brown, Intermountain Health Care, Inc.

Study Description
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Brief Summary:
This study will use systems biology techniques, especially RNA-seq, to understand cognitive impairment after sepsis requiring an intensive care unit (ICU) admission.

Condition or disease
Sepsis Cognitive Impairment

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)
Study Start Date : June 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Groups and Cohorts
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Group/Cohort
Septic patients admitted to the ICU


Outcome Measures
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Primary Outcome Measures :
  1. Hayling Sentence Completion test [ Time Frame: 6 months ]
    Measures executive function. 6-month Hayling Sentence Completion test is the prespecified primary outcome.


Secondary Outcome Measures :
  1. Wechsler Memory Scale Logical Memory 1 assessment [ Time Frame: 3 months ]
  2. Wechsler Memory Scale Logical Memory 1 assessment [ Time Frame: 6 months ]
  3. Wechsler Memory Scale Logical Memory 2 assessment [ Time Frame: 3 months ]
  4. Wechsler Memory Scale Logical Memory 2 assessment [ Time Frame: 6 months ]
  5. Digit Span memory assessment [ Time Frame: 3 months ]
  6. Digit Span memory assessment [ Time Frame: 6 months ]
  7. Verbal Fluency test [ Time Frame: 3 months ]
  8. Verbal Fluency test [ Time Frame: 6 months ]
  9. Wechsler Similarities assessment [ Time Frame: 3 months ]
  10. Wechsler Similarities assessment [ Time Frame: 6 months ]
  11. EuroQol five dimensions questionnaire (EQ-5D-3L) [ Time Frame: 3 months ]
  12. EuroQol five dimensions questionnaire (EQ-5D-3L) [ Time Frame: 6 months ]
  13. 36-item short form survey (SF-36) [ Time Frame: 3 months ]
  14. 36-item short form survey (SF-36) [ Time Frame: 6 months ]
  15. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 months ]
  16. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 6 months ]
  17. Impact of Event Scale-Revised (IES-R) [ Time Frame: 3 months ]
  18. Impact of Event Scale-Revised (IES-R) [ Time Frame: 6 months ]
  19. Functional Performance Inventory (FPI) [ Time Frame: 3 months ]
  20. Functional Performance Inventory (FPI) [ Time Frame: 6 months ]
  21. Functional Assessment of Chronic Illness Therapy (FACIT) [ Time Frame: 3 months ]
  22. Functional Assessment of Chronic Illness Therapy (FACIT) [ Time Frame: 6 months ]
  23. Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) [ Time Frame: 3 months ]
  24. Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) [ Time Frame: 6 months ]
  25. Hayling Sentence Completion test [ Time Frame: 3 months ]

Other Outcome Measures:
  1. 90-day mortality [ Time Frame: 90 days ]

Biospecimen Retention:   Samples With DNA
Blood for RNA-seq and whole exome sequencing

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with sepsis or septic shock, admitted to the ICU.
Criteria

Inclusion Criteria

- Either SEPSIS or SEPTIC SHOCK

A. SEPSIS:

PRESENCE OF

  1. Suspected or confirmed infection AND
  2. Organ dysfunction as defined by a SOFA >= 2 above baseline (if no baseline data available, SOFA assumed to be 0)

OR

B. SEPTIC SHOCK:

AFTER INTRAVENOUS INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, PRESENCE OF

  1. Suspected or confirmed infection AND
  2. Lactate > 2 mmol/L AND
  3. Receiving vasopressors

Enrollment within 48 hours of ICU admission.

Must live within 200 miles of Intermountain Medical Center

Subject is at least 18 years of age or older

Must speak English

Exclusion Criteria:

  • Onset of sepsis or septic shock >24 hours after hospital admission
  • Patients transferred from another hospital except for directly from an emergency room
  • Patients transferred to the ICU >48 hours after admission to Intermountain Medical Center (must have been admitted with diagnosis of sepsis)
  • Prior traumatic brain injury, stroke, or intracranial hemorrhage
  • DNR/DNI order before study enrollment
  • Primary diagnosis of stroke or intracranial hemorrhage
  • Known preexisting dementia or substantial cognitive impairment of any cause (established from both chart review, report and/or score ≥3 on IQ Code screening.
  • Prior cardiac surgery (coronary artery bypass grafting or surgical valve replacement or repair)
  • Known schizophrenia or other psychotic thought disorder
  • Known pregnancy
  • Primary diagnosis of drug overdose
  • Attending physician deems aggressive care unsuitable
  • Enrolled in another study if that study involves drug interventions
  • Not expected to survive 48 hours
  • Has a terminal condition independent of the acute illness that is expected to lead to death within 6 months
Contacts and Locations
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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): NCT03015584


Locations
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United States, Utah
Intermountain Medical Center
Salt Lake City, Utah, United States, 84157
Sponsors and Collaborators
Intermountain Health Care, Inc.
University of Utah
Investigators
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Principal Investigator: Samuel Brown, MD Intermountain Health Care, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Samuel Brown, Director of Center for Humanizing Critical Care; Assistant Director of Critical Care Echocardiography Service, Intermountain Medical Center, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT03015584    
Other Study ID Numbers: 1040524
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Cognitive Dysfunction
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders