Anticardiolipin Autoantibodies and Mortality in Septic Patients

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04685278

Acronym

aCLsepsis

Enrollment

Registered

2020-12-28

Start date

2020-10-01

Completion date

2021-02-15

Last updated

2020-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morality

Keywords

anti-phospholipid, sepsis, intensive care unit

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.

Interventions

BIOLOGICALBlood samples

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Tunisia

Contacts

Primary ContactZied Hajjej, Pr

hajjej_zied@hotmail.com0021620358907

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026