Cognitive Impairment, Sepsis
Conditions
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.
Interventions
None listed
Sponsors
University of Utah
Intermountain Health Care, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hayling Sentence Completion test | 6 months | Measures executive function. 6-month Hayling Sentence Completion test is the prespecified primary outcome. |
Secondary
| Measure | Time frame |
|---|---|
| Functional Assessment of Chronic Illness Therapy (FACIT) | 3 months |
| Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | 3 months |
| Hayling Sentence Completion test | 3 months |
| Wechsler Memory Scale Logical Memory 1 assessment | 3 months |
| Wechsler Memory Scale Logical Memory 2 assessment | 3 months |
| Digit Span memory assessment | 3 months |
| Wechsler Similarities assessment | 3 months |
| EuroQol five dimensions questionnaire (EQ-5D-3L) | 3 months |
| 36-item short form survey (SF-36) | 3 months |
| Hospital Anxiety and Depression Scale (HADS) | 3 months |
| Impact of Event Scale-Revised (IES-R) | 3 months |
| Functional Performance Inventory (FPI) | 3 months |
| Verbal Fluency test | 3 months |
Other
| Measure | Time frame |
|---|---|
| 90-day mortality | 90 days |
Countries
United States
Outcome results
None listed