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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01530854

Enrollment

Registered

2012-02-10

Start date

2008-02-01

Completion date

2012-01-01

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

sepsis, free fatty acids, emergency department

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Disposition: Admission to hospital or discharge home	within 48 h
Hospital length-of-stay	30 days

Secondary

Measure	Time frame
All cause mortality	30 days

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRakesh Engineer, MD

The Cleveland Clinic

Outcome results