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Completed

NCT Number: NCT03015584

Systems Biology Approach to Cognitive Impairment After SepsiS

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intermountain Medical Center

Salt Lake City, Utah, 84157, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Either SEPSIS or SEPTIC SHOCK

A. SEPSIS:

PRESENCE OF

  • Suspected or confirmed infection AND
  • 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

  • Suspected or confirmed infection AND
  • Lactate > 2 mmol/L AND
  • 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

Treatment and study plan

Primary outcomes

  1. Hayling Sentence Completion test

    Time frame: 6 months

    Measures executive function. 6-month Hayling Sentence Completion test is the prespecified primary outcome.

Secondary outcomes

  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 outcomes

  1. 90-day mortality

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • University of Utah

Registry information

Official study title

Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)

Acronym: CASS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 10, 2017
Registry last updated
Jul 18, 2018

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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