Systems Biology Approach to Cognitive Impairment After SepsiS

Sepsis Clinical Trial

— CASS  

Official title:

Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015584
• Other study ID #: 1040524
• Status: Completed
• Start date: June 2015
• Est. completion date: July 2017

Study information

• Verified date: July 2018
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Sepsis
• Toxemia

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	90-day mortality		90 days
Primary	Hayling Sentence Completion test	Measures executive function. 6-month Hayling Sentence Completion test is the prespecified primary outcome.	6 months
Secondary	Wechsler Memory Scale Logical Memory 1 assessment		3 months
Secondary	Wechsler Memory Scale Logical Memory 1 assessment		6 months
Secondary	Wechsler Memory Scale Logical Memory 2 assessment		3 months
Secondary	Wechsler Memory Scale Logical Memory 2 assessment		6 months
Secondary	Digit Span memory assessment		3 months
Secondary	Digit Span memory assessment		6 months
Secondary	Verbal Fluency test		3 months
Secondary	Verbal Fluency test		6 months
Secondary	Wechsler Similarities assessment		3 months
Secondary	Wechsler Similarities assessment		6 months
Secondary	EuroQol five dimensions questionnaire (EQ-5D-3L)		3 months
Secondary	EuroQol five dimensions questionnaire (EQ-5D-3L)		6 months
Secondary	36-item short form survey (SF-36)		3 months
Secondary	36-item short form survey (SF-36)		6 months
Secondary	Hospital Anxiety and Depression Scale (HADS)		3 months
Secondary	Hospital Anxiety and Depression Scale (HADS)		6 months
Secondary	Impact of Event Scale-Revised (IES-R)		3 months
Secondary	Impact of Event Scale-Revised (IES-R)		6 months
Secondary	Functional Performance Inventory (FPI)		3 months
Secondary	Functional Performance Inventory (FPI)		6 months
Secondary	Functional Assessment of Chronic Illness Therapy (FACIT)		3 months
Secondary	Functional Assessment of Chronic Illness Therapy (FACIT)		6 months
Secondary	Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)		3 months
Secondary	Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)		6 months
Secondary	Hayling Sentence Completion test		3 months