Systems Biology Approach to Cognitive Impairment After SepsiS

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

Official Title
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Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)

Conditions
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Sepsis, Cognitive Impairment

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Septic patients admitted to the ICU<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hayling Sentence Completion test | Measures executive function. 6-month Hayling Sentence Completion test is the prespecified primary outcome. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wechsler Memory Scale Logical Memory 1 assessment |  | 3 months | 
| Wechsler Memory Scale Logical Memory 1 assessment |  | 6 months | 
| Wechsler Memory Scale Logical Memory 2 assessment |  | 3 months | 
| Wechsler Memory Scale Logical Memory 2 assessment |  | 6 months | 
| Digit Span memory assessment |  | 3 months | 
| Digit Span memory assessment |  | 6 months | 
| Verbal Fluency test |  | 3 months | 
| Verbal Fluency test |  | 6 months | 
| Wechsler Similarities assessment |  | 3 months | 
| Wechsler Similarities assessment |  | 6 months | 
| EuroQol five dimensions questionnaire (EQ-5D-3L) |  | 3 months | 
| EuroQol five dimensions questionnaire (EQ-5D-3L) |  | 6 months | 
| 36-item short form survey (SF-36) |  | 3 months | 
| 36-item short form survey (SF-36) |  | 6 months | 
| Hospital Anxiety and Depression Scale (HADS) |  | 3 months | 
| Hospital Anxiety and Depression Scale (HADS) |  | 6 months | 
| Impact of Event Scale-Revised (IES-R) |  | 3 months | 
| Impact of Event Scale-Revised (IES-R) |  | 6 months | 
| Functional Performance Inventory (FPI) |  | 3 months | 
| Functional Performance Inventory (FPI) |  | 6 months | 
| Functional Assessment of Chronic Illness Therapy (FACIT) |  | 3 months | 
| Functional Assessment of Chronic Illness Therapy (FACIT) |  | 6 months | 
| Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) |  | 3 months | 
| Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) |  | 6 months | 
| Hayling Sentence Completion test |  | 3 months |