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

• ClinicalTrials.gov Identifier: NCT01530854
• Recruitment Status: Completed
• First Posted: February 10, 2012
• Last Update Posted: March 17, 2017
• Sponsor: The Cleveland Clinic
• Collaborator: Cheetah Medical Inc.
• Information provided by (Responsible Party): Rakesh Engineer, The Cleveland Clinic

Study Description

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.

Condition or disease
Sepsis

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 Design

• Study Type: Observational
• Actual Enrollment: 74 participants
• 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
• Study Start Date: February 2008
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Groups and Cohorts

Group/Cohort
Septic
Healthy

Outcome Measures

Primary Outcome Measures :

1. Disposition: Admission to hospital or discharge home [ Time Frame: within 48 h ]
2. Hospital length-of-stay [ Time Frame: 30 days ]

Secondary Outcome Measures :

1. All cause mortality [ Time Frame: 30 days ]

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Rakesh Engineer, Principal Investigator, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01530854
• Other Study ID Numbers: 07-969; 07-969 ( Other Identifier: Cleveland Clinic )
• First Posted: February 10, 2012
• Last Update Posted: March 17, 2017
• Last Verified: March 2017

Keywords provided by Rakesh Engineer, The Cleveland Clinic:

sepsis; free fatty acids; emergency department

Additional relevant MeSH terms:

Sepsis; Toxemia; Emergencies; Disease Attributes; Pathologic Processes; Infection; Systemic Inflammatory Response Syndrome; Inflammation