Plasma Free Fatty Acids in Risk Assessment of Sepsis in the Emergency Department: A Prospective Pilot Study

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.

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Key information

Conditions

Sepsis Disease Attributes Emergencies Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Disposition: Admission to hospital or discharge home

Time frame: within 48 h
Hospital length-of-stay

Time frame: 30 days

Secondary outcomes

All cause mortality

Time frame: 30 days

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

Cheetah Medical Inc.

Registry information

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Feb 10, 2012
Registry last updated: Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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