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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530854
• Other study ID #: 07-969
• Secondary ID: 07-969
• Status: Completed
• Phase: N/A
• First received: February 8, 2012
• Last updated: March 15, 2017
• Start date: February 2008
• Est. completion date: January 2012

Study information

• Verified date: March 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Toxemia

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Cheetah Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disposition: Admission to hospital or discharge home		within 48 h
Primary	Hospital length-of-stay		30 days
Secondary	All cause mortality		30 days