Plasma Free Fatty Acids in Risk Assessment of Sepsis in the Emergency Department: A Prospective Pilot Study
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 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|
- 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 ]
- 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.
|Study Start Date:||February 2008|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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:
- To determine if plasma FFA levels are related to severity of illness in patients with sepsis presenting to the Emergency Department.
- To study the prognostic value of plasma FFA levels at predicting future morbidity and mortality in patients with sepsis presenting to the Emergency Department.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530854
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Rakesh Engineer, MD||The Cleveland Clinic|
|Principal Investigator:||Caitlin W Hicks, BA||The Cleveland Clinic|