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Clinical Trials/NCT06612307
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

Registry
clinicaltrials.gov
Start Date
September 25, 2024
End Date
August 20, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Minia University
Responsible Party
Principal Investigator
Principal Investigator

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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