Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)

Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)

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

Study Overview

• Status: Completed
• Conditions: Sepsis; Cognitive Impairment

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84157
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with sepsis or septic shock, admitted to the ICU.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Septic patients admitted to the ICU

What is the study measuring?

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	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

Other Outcome Measures

Outcome Measure	Time Frame
90-day mortality	90 days

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: University of Utah

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: December 8, 2016
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (ESTIMATE): January 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Neurocognitive Disorders; Cognition Disorders; Sepsis; Toxemia; Cognitive Dysfunction
• Other Study ID Numbers: 1040524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO