Clinical trial NCT03015584: Systems Biology Approach to Cognitive Impairment After SepsiS
Official title: Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Cognitive Impairment
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2017-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sepsis or septic shock, admitted to the ICU.

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.


Eligibility 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

Primary outcomes:
measure: Hayling Sentence Completion test
timeFrame: 6 months
Secondary outcomes:
measure: Wechsler Memory Scale Logical Memory 1 assessment
timeFrame: 3 months
measure: Wechsler Memory Scale Logical Memory 1 assessment
timeFrame: 6 months
measure: Wechsler Memory Scale Logical Memory 2 assessment
timeFrame: 3 months
measure: Wechsler Memory Scale Logical Memory 2 assessment
timeFrame: 6 months
measure: Digit Span memory assessment
timeFrame: 3 months
measure: Digit Span memory assessment
timeFrame: 6 months
measure: Verbal Fluency test
timeFrame: 3 months
measure: Verbal Fluency test
timeFrame: 6 months
measure: Wechsler Similarities assessment
timeFrame: 3 months
measure: Wechsler Similarities assessment
timeFrame: 6 months
measure: EuroQol five dimensions questionnaire (EQ-5D-3L)
timeFrame: 3 months
measure: EuroQol five dimensions questionnaire (EQ-5D-3L)
timeFrame: 6 months
measure: 36-item short form survey (SF-36)
timeFrame: 3 months
measure: 36-item short form survey (SF-36)
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: Impact of Event Scale-Revised (IES-R)
timeFrame: 3 months
measure: Impact of Event Scale-Revised (IES-R)
timeFrame: 6 months
measure: Functional Performance Inventory (FPI)
timeFrame: 3 months
measure: Functional Performance Inventory (FPI)
timeFrame: 6 months
measure: Functional Assessment of Chronic Illness Therapy (FACIT)
timeFrame: 3 months
measure: Functional Assessment of Chronic Illness Therapy (FACIT)
timeFrame: 6 months
measure: Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
timeFrame: 3 months
measure: Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
timeFrame: 6 months
measure: Hayling Sentence Completion test
timeFrame: 3 months
Other outcomes:
measure: 90-day mortality
timeFrame: 90 days
Locations:
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Samuel Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown SM, Collingridge DS, Wilson EL, Beesley S, Bose S, Orme J, Jackson J, Hopkins RO. Preliminary Validation of the Montreal Cognitive Assessment Tool among Sepsis Survivors: A Prospective Pilot Study. Ann Am Thorac Soc. 2018 Sep;15(9):1108-1110. doi: 10.1513/AnnalsATS.201804-233OC. No abstract available.