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

NeuroTherapia, Inc.

Status: Completed

Conditions: Sepsis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01530854

07-969 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

74 participants in 2 patient groups

Septic

Healthy