MoralityaCLsepsisNCT04685278
Anticardiolipin Autoantibodies and Mortality in Septic Patients
An observational study of Morality, run by Military Hospital of Tunis at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morality
- What is being tested?
- Blood samples
- How many people
- 50 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Oct 2020to 15 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients, admitted to the ICU for sepsis
Who may be able to join
- patients, admitted to the ICU for sepsis and older than 18 years
Who cannot join
- pregnancy
- clinical history of antiphospholipid syndrome
- auto-immune diseases
- immunosuppressive treatment
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Military Hospital of Tunisia
Tunis, 1008
Iheb Labbene, Pr, 0021698336213, iheb.labbene@fmt.utm.tn
About this study
Official title: 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.
Read the 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.
- Conditions
- Morality
- Being tested
- Blood samples
- Keywords
- anti-phospholipid, sepsis, intensive care unit
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
Blood samples were collected in dry tubes on days 1, 3, 5, 8 and 10 of hospitalization
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Mortality was defined as death before ICU discharge Multivariate logistic regression modeling will beperformed to found factors associated with higher mortality
Measured: mortality at day 14 of hospitalization
Secondary outcomes (1)
correlation between SOFA score and antiphospholipid antibodies.
assess correlations between serum levels of both aCL and aPS and SOFA score
Measured: on days 1, 3, 5, 8 and 10 of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Oct 2020
- Primary completion5 Feb 2021 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoralityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Hospital of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajjej Zied, Military Hospital of Tunis
- Investigators
- Iheb Labbene, Pr, Study director, Military Hospital of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685278
- Sponsor's protocol ID
- Military Hospital of Tunis
- Acronym
- aCLsepsis
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticardiolipin Autoantibodies as Useful Biomarker for the Prediction of Mortality in Septic Patients
- ClinicalTrials.gov ID
- NCT04685278
- Acronym / sponsor ID
- aCLsepsis / Military Hospital of Tunis
- Conditions
- Morality
- Keywords
- anti-phospholipid, sepsis, intensive care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Military Hospital of TunisUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 5 Feb 2021 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients, admitted to the ICU for sepsis
Key inclusion criteria (1 listed)
- patients, admitted to the ICU for sepsis and older than 18 years
Key exclusion criteria (4 listed)
- pregnancy
- clinical history of antiphospholipid syndrome
- auto-immune diseases
- immunosuppressive treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesBlood samples were collected in dry tubes on days 1, 3, 5, 8 and 10 of hospitalization | Biological | – |
Primary outcome
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
1 secondary outcome
correlation between SOFA score and antiphospholipid antibodies.
Time frame: on days 1, 3, 5, 8 and 10 of hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iheb Labbene, Pr study director
Military Hospital of Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morality, run by Military Hospital of Tunis at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zied Hajjej, Pr (0021620358907, hajjej_zied@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: mortality at day 14 of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.