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Anticardiolipin Autoantibodies and Mortality in Septic Patients

NCT ID: NCT04685278

Last Updated: 2020-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-02-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Morality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood samples

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Military Hospital of Tunis

OTHER

Sponsor Role lead

Responsible Party

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Hajjej Zied

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iheb Labbene, Pr

Role: STUDY_DIRECTOR

Military Hospital of Tunis

Locations

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Military Hospital of Tunisia

Tunis, , Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Zied Hajjej, Pr

Role: CONTACT

[email protected]
0021620358907

Facility Contacts

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Iheb Labbene, Pr

Role: primary

[email protected]
0021698336213

Other Identifiers

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Military Hospital of Tunis

Identifier Type: -

Identifier Source: org_study_id

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