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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04685278
Other study ID # Military Hospital of Tunis
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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