Systems Biology Approach to Cognitive Impairment After SepsiS

Completed

• Conditions: Sepsis; Cognitive Impairment

• Registration Number: NCT03015584
• Lead Sponsor: Intermountain Health Care, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-10
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Salt Lake City, Utah, United States