Anticardiolipin Autoantibodies and Mortality in Septic Patients (aCLsepsis)

December 22, 2020 updated by: Hajjej Zied, Military Hospital of Tunis

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tunisia
      • Tunis, Tunisia, 1008
        • Recruiting
        • Military Hospital of Tunisia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients, admitted to the ICU for sepsis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU mortality
Time Frame: 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
mortality at day 14 of hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between SOFA score and antiphospholipid antibodies.
Time Frame: on days 1, 3, 5, 8 and 10 of hospitalization
assess correlations between serum levels of both aCL and aPS and SOFA score
on days 1, 3, 5, 8 and 10 of hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Military Hospital of Tunis

Investigators

  • Study Director: Iheb Labbene, Pr, Military Hospital of Tunis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

February 5, 2021

Study Completion (Anticipated)

February 15, 2021

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

December 28, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Military Hospital of Tunis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Morality

Clinical Trials on Blood samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe