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

NCT01998139 | Completed DMC

• 3 other identifiers: 1305013944NPRP 6-1348-3-32113-00309
• Study Type: observational
• Target: 137
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Systemic Inflammatory Response Syndrome

Outcome Measures

Primary Outcomes (1)

• EMP level as predictive biomarker for diagnosis of sepsis.

  To evaluate the hypothesis that EMP level is a predictive biomarker for the diagnosis of sepsis. For the primary objective, a prospective, cross-sectional, case control design will be utilized. EMP levels will be measured at ICU admission in subjects with physician-suspected sepsis. For each subject, the final diagnosis of sepsis or non-sepsis critical illness will be adjudicated using standard criteria, and the subjects determined to have sepsis will serve as the cases while those subjects without sepsis will form the control group.

  5 days

Secondary Outcomes (1)

• EMP level as a predictive biomarker for mortality in sepsis.

  30 days

Study Arms (2)

Test Cohort

EMP levels will be measured at ICU admission in subjects with physician-suspected sepsis. For each subject, the final diagnosis of sepsis or non-sepsis critical illness will be adjudicated using standard criteria. The subjects without sepsis will form the Test Cohort.

Validation Cohort

EMP levels will be measured at ICU admission in subjects with physician-suspected sepsis. For each subject, the final diagnosis of sepsis or non-sepsis critical illness will be adjudicated using standard criteria.The subjects determined to have sepsis will serve as the Validation Cohort .

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be eligible for enrollment at the time of clinician decision to admit to the Medical Intensive Care Unit (MICU) for presumed sepsis.

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Hamad Medical Corporation: collaborator

Study Sites (2)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Hamad Medical Corporation

Doha, Qatar

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Ronald G Crystal, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 28, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

US (1); QA (1)