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

NCT01530854 | Completed

• 1 other identifier: 07-969
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

sepsis; free fatty acids; emergency department

Outcome Measures

Primary Outcomes (2)

• Disposition: Admission to hospital or discharge home

  within 48 h

• Hospital length-of-stay

  30 days

Secondary Outcomes (1)

• All cause mortality

  30 days

Study Arms (2)

Septic

Healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Cheetah Medical Inc.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (10 cc. total) are to be collected in non-heparinized tubes upon initial presentation to the ED as well as 3-6hours and 24(+/-3) hours after the initial blood draw. The 3-6hour and 24-hour blood draw will be optional depending on patient location and the availability of study personnel. The plasma samples will be aliquoted and frozen at -70°C for later assays. These samples will be assayed for plasma FFA, plasma glucose, plasma insulin, and future cytokines including IL-1 and TNF.

MeSH Terms

Conditions

Sepsis; Emergencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Rakesh Engineer, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Caitlin W Hicks, BA

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 10, 2012
• Study Start: February 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 17, 2017

Record last verified: 2017-03

Locations

US (1)