Systems Biology Approach to Cognitive Impairment After SepsiS

NCT03015584 | Completed

• 1 other identifier: 1040524
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Hayling Sentence Completion test

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

  6 months

Secondary Outcomes (25)

• 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

Other Outcomes (1)

• 90-day mortality

  90 days

Study Arms (1)

Septic patients admitted to the ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• University of Utah: collaborator

Study Sites (1)

Intermountain Medical Center

Salt Lake City, Utah, 84157, United States

Location

Related Publications (1)

• 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.

  PMID: 30168744 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood for RNA-seq and whole exome sequencing

MeSH Terms

Conditions

Sepsis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Samuel Brown, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center for Humanizing Critical Care; Assistant Director of Critical Care Echocardiography Service, Intermountain Medical Center

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: January 10, 2017
• Study Start: June 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)