Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)

Intermountain Health Care, Inc.

Status: Completed

Conditions: Cognitive Impairment; Sepsis

Study type: Observational

Funder types: Other

Identifiers

NCT03015584

1040524

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

40 participants in 1 patient group

Septic patients admitted to the ICU