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Clinical Trials/NCT04685278
NCT04685278UnknownNot Applicable

Anticardiolipin Autoantibodies as Useful Biomarker for the Prediction of Mortality in Septic Patients

Military Hospital of Tunis1 site in 1 country50 target enrollmentStarted: October 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
ICU mortality

Study Overview

Brief Summary

The detection of antiphospholipid antibodies (aPL) is of interest because of their importance in the pathogenesis of arterial or venous thrombosis and their responsibility for a wide spectrum of clinical manifestations such as infection. The aim of the study was to assess the performance of antiphospholipid antibodies biomarker to predict in- hospital mortality in intensive care unit (ICU) septic patient's.

Detailed Description

the investigators conducted a prospective single-center observational study including consecutive critically ill septic adults admitted to the intensive care unit. Clinical and laboratory data including chemiluminescence immunoassay for antiphospholipid antibodies [anticardiolipin (aCL), antiphosphatidylserine (aPS)] were obtained. Blood samples were collected on days 1, 3, 5, 8 and 10 of hospitalization. The primary study endpoint was ICU mortality defined as death before ICU discharge. Secondary end points included correlation between SOFA score and biological parameters.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients, admitted to the ICU for sepsis and older than 18 years

Exclusion Criteria

  • pregnancy
  • clinical history of antiphospholipid syndrome
  • auto-immune diseases
  • immunosuppressive treatment

Outcomes

Primary Outcomes

ICU mortality

Time Frame: mortality at day 14 of hospitalization

Mortality was defined as death before ICU discharge Multivariate logistic regression modeling will beperformed to found factors associated with higher mortality

Secondary Outcomes

  • correlation between SOFA score and antiphospholipid antibodies.(on days 1, 3, 5, 8 and 10 of hospitalization)

Investigators

Sponsor
Military Hospital of Tunis
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hajjej Zied

Professor

Military Hospital of Tunis

Study Sites (1)

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