Anticardiolipin Autoantibodies and Mortality in Septic Patients

• Conditions: Morality

• Registration Number: NCT04685278
• Lead Sponsor: Military Hospital of Tunis

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 Timeline

• Study Start: 2020-10-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-22
• Last Update Submitted: 2020-12-22
• Study First Posted: 2020-12-28
• Last Update Posted: 2020-12-28
• Primary Completion: 2021-02-05
• Study Completion: 2021-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICU mortality	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 Outcome Measures

Name	Time	Method
correlation between SOFA score and antiphospholipid antibodies.	on days 1, 3, 5, 8 and 10 of hospitalization	assess correlations between serum levels of both aCL and aPS and SOFA score

Trial Locations

Locations (1)

Military Hospital of Tunisia; 🇹🇳 Tunis, Tunisia