Plasma Free Fatty Acids in Risk Assessment of Sepsis in the Emergency Department: A Prospective Pilot Study
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ClinicalTrials.gov Identifier: NCT01530854 |
Recruitment Status :
Completed
First Posted : February 10, 2012
Last Update Posted : March 17, 2017
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Condition or disease |
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Sepsis |
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.
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 |
Group/Cohort |
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Septic |
Healthy |
- Disposition: Admission to hospital or discharge home [ Time Frame: within 48 h ]
- Hospital length-of-stay [ Time Frame: 30 days ]
- All cause mortality [ Time Frame: 30 days ]
Biospecimen Retention: Samples With DNA

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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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530854
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | Rakesh Engineer, MD | The Cleveland Clinic | |
Principal Investigator: | Caitlin W Hicks, BA | The Cleveland Clinic |
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 Key Record Dates |
Last Update Posted: | March 17, 2017 |
Last Verified: | March 2017 |
sepsis free fatty acids emergency department |
Sepsis Toxemia Emergencies Disease Attributes |
Pathologic Processes Infection Systemic Inflammatory Response Syndrome Inflammation |