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

Completed

• Conditions: Sepsis

• Registration Number: NCT01530854
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
All cause mortality	30 days

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States