Systems Biology Approach to Cognitive Impairment After SepsiS

Completed

Conditions studied: Sepsis, Cognitive Impairment

In brief

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

Key facts

Study ID

NCT03015584

Run by

Intermountain Health Care, Inc.

People needed

40

Starts

2015-06-01

Expected to finish

2017-07-01

Last updated by the study team

2018-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• 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

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

Where it is running

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

Full record on ClinicalTrials.gov

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