Endothelial Microparticles as a Biomarker for Diagnosis and Prognosis in Early Sepsis

Completed

Conditions studied: Systemic Inflammatory Response Syndrome

In brief

Sepsis is a major global health problem, leading to substantial morbidity and mortality despite medical care. The initial diagnosis of sepsis is a clinical challenge, as it is based on nonspecific systemic criteria. Excessive endothelial activation is a cardinal feature of sepsis and contributes to microvascular leak, edema, circulatory shock and organ failure. Activated endothelial cells shed endothelial microparticles (EMPs) which can be measured in plasma and are found at low levels in healthy subjects. Elevated EMPs have been reported in sepsis, but whether their effect is beneficial or deleterious is unclear. In this context, we hypothesize that circulating EMP levels can be assessed as a biomarker differentiating sepsis from non-sepsis critical illness. This may also suggest that EMP levels correlate with 30-day mortality. We propose to measure circulating EMPs at ICU admission in subjects with suspected sepsis. Final diagnoses will be adjudicated using standard criteria and 30-day mortality ascertained. Subjects determined not to have sepsis will serve as the control group. EMP levels will be correlated with diagnosis to ascertain the utility of EMP levels as a diagnostic biomarker for sepsis. For those subjects with proven sepsis, EMP levels will be correlated to 30-day mortality to assess EMP level as a prognostic marker in sepsis.

Key facts

Study ID

NCT01998139

Run by

Weill Medical College of Cornell University

People needed

137

Starts

2013-07-01

Expected to finish

2019-02-01

Last updated by the study team

2020-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults age 18 and older
• Clinician-suspected diagnosis of sepsis
• Willingness of subject or Legally Authorized Representative (LAR) to participate in the study

You may not qualify if…

• Desire to forego life-sustaining therapy
• Trauma or surgical subjects
• Pregnancy
• Subjects who, in the opinion of the treating physician and/or investigator, would be at increased risk by the additional blood draw, for instance, subjects with severe anemia, or subjects with anemia who are unwilling or unable to receive blood transfusions

Where it is running

• Weill Cornell Medical College — New York, New York, United States
• Hamad Medical Corporation — Doha, Qatar

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.