Sensitivity and Specificity of Leucocytes Subpopulation Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Observational Clinical Trial
Not yet recruiting
- Conditions
- Sepsis
- Registration Number
- NCT06612307
- Lead Sponsor
- Minia University
- Brief Summary
Leucocyte subpopulation and platelet indices analysis can predict clinical outcome
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 161
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity of either leucocyte subpopulation, platelet indices with early clinical outcome 1 week Post hoc analysis .... \< 50 %= poor sensitivity..... \> 50%= strong sensitivity
Specificity of either leucocyte subpopulation, platelet indices with early clinical outcome 1 week Post hoc analysis .... \< 50 %= poor sensitivity..... \> 50%= strong sensitivity
- Secondary Outcome Measures
Name Time Method correlation between leucocytes at enrollment , 7 days with ICU mortality 1 week correlation between platelet indices at enrollment , 7 days with ICU mortality one week correlation between platelet indices at enrollment , 7 days with incidence of mechanical ventilation 1 week correlation between leucocytes at enrollment , 7 days with incidence of mechanical ventilation 1week correlation between leucocytes at enrollment , 7 days with incidence of acute kidney injury 1 week correlation between platelet indices at enrollment , 7 days with incidence of acute kidney injury 1 week