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

This study has been completed.
Sponsor:
Collaborator:
Cheetah Medical Inc.
Information provided by (Responsible Party):
Caitlin Hicks, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01530854
First received: February 8, 2012
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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.


Condition
Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plasma Free Fatty Acids in Risk Assessment of Sepsis in the Emergency Department: A Prospective Pilot Study

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Disposition: Admission to hospital or discharge home [ Time Frame: within 48 h ] [ Designated as safety issue: No ]
  • Hospital length-of-stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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.


Enrollment: 74
Study Start Date: February 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Septic
Healthy

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530854

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Cheetah Medical Inc.
Investigators
Principal Investigator: Rakesh Engineer, MD The Cleveland Clinic
Principal Investigator: Caitlin W Hicks, BA The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Caitlin Hicks, Medical Student, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01530854     History of Changes
Other Study ID Numbers: 07-969, 07-969
Study First Received: February 8, 2012
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
sepsis
free fatty acids
emergency department

Additional relevant MeSH terms:
Emergencies
Sepsis
Toxemia
Disease Attributes
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 21, 2014