NCT06612307
Not yet recruiting
Not Applicable
Sensitivity and Specificity of Leucocytes Subpopulation Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Clinical Trial
Minia University0 sites161 target enrollmentSeptember 25, 2024
ConditionsSepsis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- Minia University
- Enrollment
- 161
- Primary Endpoint
- Sensitivity of either leucocyte subpopulation, platelet indices with early clinical outcome
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
Leucocyte subpopulation and platelet indices analysis can predict clinical outcome
Investigators
Mina Maher
Ass professor anesthesia and pain
Minia University
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).
Outcomes
Primary Outcomes
Sensitivity of either leucocyte subpopulation, platelet indices with early clinical outcome
Time Frame: 1 week
Post hoc analysis .... \< 50 %= poor sensitivity..... \> 50%= strong sensitivity
Specificity of either leucocyte subpopulation, platelet indices with early clinical outcome
Time Frame: 1 week
Post hoc analysis .... \< 50 %= poor sensitivity..... \> 50%= strong sensitivity
Secondary Outcomes
- 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)
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