Clinical trial NCT01530854: Plasma Free Fatty Acids in Risk Assessment of Sepsis in the Emergency Department: A Prospective Pilot Study
Official title: Plasma Free Fatty Acids in Risk Assessment of Sepsis in the Emergency Department: A Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: sepsis
free fatty acids
emergency department
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Cheetah Medical Inc.
First posted: 2012-02-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective, specimen-procurement pilot study that will enroll adult patients (aged 18 years or older) who present to the Cleveland Clinic Emergency Department with suspected infection.

Brief summary: Plasma free fatty acids (FFAs) are thought to play a role in the generation of organ dysfunction. The investigators hypothesize that plasma FFA levels are a marker of poor prognosis in patients with sepsis. The present study will examine the relation between plasma FFA levels and severity of illness in patients with sepsis presenting to the Emergency Department. It will also examine the relation between plasma FFA levels and the risk of developing late morbidity, multiple organ dysfunction syndrome (MODS) and/or mortality during initial hospitalization and over a 30-day follow-up period.

Detailed description: The long term objective of this study is to investigate the mechanism by which plasma free fatty acids (FFAs) contribute to the progression of sepsis severity in infectious patients presenting to the Emergency Department. In the present study, pilot data will be generated to validate our hypothesis that elevated free fatty acids are related to outcome in sepsis.

We will examine our hypotheses with the following specific aims:

1. To determine if plasma FFA levels are related to severity of illness in patients with sepsis presenting to the Emergency Department.
2. To study the prognostic value of plasma FFA levels at predicting future morbidity and mortality in patients with sepsis presenting to the Emergency Department.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Able to provide informed consent (or has surrogate present that can do so)
* Presenting to the Emergency Department (ED) for evaluation
* Clinical suspicion of infection, as indicated by the ED physician's ordering a blood culture or a current temperature of ≥38C.

Exclusion Criteria:

* Liver disease
* Hepatitis
* Alcohol consumption \>2 drinks/day for longer than 6 months
* Pregnant women
* Prisoners or other institutionalized individuals
* Unable to speak the English language
* Unwilling or unlikely to be reachable by telephone for the 30-day follow-up status assessment call

Primary outcomes:
measure: Disposition: Admission to hospital or discharge home
timeFrame: within 48 h
measure: Hospital length-of-stay
timeFrame: 30 days
Secondary outcomes:
measure: All cause mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Rakesh Engineer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Caitlin W Hicks, BA
role: PRINCIPAL_INVESTIGATOR
References: