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

May 28, 2026 updated by: The Cleveland Clinic
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy
Septic

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Cheetah Medical Inc.

Investigators

  • Principal Investigator: Rakesh Engineer, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 8, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimated)

February 10, 2012

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-969 (Other Identifier: Cleveland Clinic)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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