Clinical trial NCT06612307: Sensitivity and Specificity of Leucocytes Subpopulation Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Observational Clinical Trial
Official title: Sensitivity and Specificity of Leucocytes Subpopulation Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Clinical Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 161
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: population admitted to the ICU with a diagnosis of sepsis were screened for inclusion within 48 h of presentation to the hospital. Sepsis was defined as per the Sepsis-3 definition, 6 ie, the presence of suspected or documented infection with organ dysfunction determined by an acute increase of sequential organ failure assessment (SOFA) score by 2 or more points

Brief summary: Leucocyte subpopulation and platelet indices analysis can predict clinical outcome


Eligibility criteria: Inclusion Criteria:

* Adult population of both sex, aged 20 or older admitted to the ICU with a diagnosis of sepsis were screened for inclusion within 48 h of presentation to the hospital. Sepsis was defined as per the Sepsis-3 definition, 6 ie, the presence of suspected or documented infection with organ dysfunction determined by an acute increase of sequential organ failure assessment (SOFA) score by 2 or more points

Exclusion Criteria:

* Patient refusal.
* History of surgery in the last 7 days from admission.
* Immunocompromised population ( post-transplantation, steroid use \> 5 mg per day, malignancy, HIV, on chemotherapy).
* Population with history of thrombocytopenia ( ITP, aplastic anemia, drug induced)
* History of thrombocytosis ( idiopathic thrombocytosis, post-splenectomy)
* History of platelet transfusion one week before admission.
* Bone marrow transplanted population .
* Chronic liver and kidney disease.
* Von-Willebrand disease.
* Patients on antiplatelet therapy ( Aspirin, clopidogrel).
* Thrombocytopenic population ( ITP, TTP,HELLP) .
* Myelodysplastic or proliferative patients.
* Blood dyscarsiasis
* Obestetric parturients.

Primary outcomes:
measure: Sensitivity of either leucocyte subpopulation, platelet indices with early clinical outcome
timeFrame: 1 week
measure: Specificity of either leucocyte subpopulation, platelet indices with early clinical outcome
timeFrame: 1 week
Secondary outcomes:
measure: correlation between leucocytes at enrollment , 7 days with ICU mortality
timeFrame: 1 week
measure: correlation between platelet indices at enrollment , 7 days with ICU mortality
timeFrame: one week
measure: correlation between platelet indices at enrollment , 7 days with incidence of mechanical ventilation
timeFrame: 1 week
measure: correlation between leucocytes at enrollment , 7 days with incidence of mechanical ventilation
timeFrame: 1week
measure: correlation between leucocytes at enrollment , 7 days with incidence of acute kidney injury
timeFrame: 1 week
measure: correlation between platelet indices at enrollment , 7 days with incidence of acute kidney injury
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
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