Anticardiolipin Autoantibodies and Mortality in Septic Patients

Morality Clinical Trial

— aCLsepsis  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04685278
• Other study ID #: Military Hospital of Tunis
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: December 2020
• Source: Military Hospital of Tunis
• Contact: Zied Hajjej, Pr
• Phone: 0021620358907
• Email: hajjej_zied[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 15, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Morality

Intervention

Biological:
• Blood samples
Blood samples were collected in dry tubes on days 1, 3, 5, 8 and 10 of hospitalization

Locations

Country	Name	City	State
Tunisia	Military Hospital of Tunisia	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Military Hospital of Tunis

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU mortality	Mortality was defined as death before ICU discharge Multivariate logistic regression modeling will beperformed to found factors associated with higher mortality	mortality at day 14 of hospitalization
Secondary	correlation between SOFA score and antiphospholipid antibodies.	assess correlations between serum levels of both aCL and aPS and SOFA score	on days 1, 3, 5, 8 and 10 of hospitalization