Sensitivity and Specificity of Leucocytes Profiling Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Observational Clinical Trial

Sensitivity and Specificity of Leucocytes Subpopulation Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Clinical Trial

Leucocyte subpopulation and platelet indices analysis can predict clinical outcome

Study Overview

• Status: Completed
• Conditions: Sepsis

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• Egypt
  • Menofia
    • Menofyia, Menofia, Egypt
      • Menofyia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.
• Diabetic population
• 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of either leucocyte profiling , platelet indices with early clinical deterioration	SOFA increase 2 points or more, or development of septic shock, or mortality. leukocyte profile versus platelet indices. Early deterioration was defined as any of the above mentioned events occurring for the first time from T0 until (through) fifth calendar day. T0 was the biomarker sampling immediately after sepsis diagnosis. Timing of deterioration was subclassified from To to fourth calendar day ( any deterioration events for the first time from T0 until fourth calendar day after that defined as very early deterioration) or on day 5 inclusive ( day-5 incident early deterioration= any deterioration events occur for the first time only on fifth calendar day inclusive after T0	from biomarker sampling through fifth calendar day

Secondary Outcome Measures

Outcome Measure	Time Frame
association between leucocytes at enrollment with ICU mortality	2 weeks ( during ICU admission)
association between platelet indices at enrollment with ICU mortality	2 weeks (during ICU admission)
association between platelet indices at enrollment with incidence of mechanical ventilation	2 weeks
association between leucocytes at enrollment with incidence of mechanical ventilation	2 weeks (during ICU admission)
association between leucocytes at enrollment , with incidence of acute kidney injury	2 weeks (during ICU admission)
association between platelet indices at enrollment with incidence of acute kidney injury	2 weeks (during ICU admission )

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Actual): September 15, 2025
• Study Completion (Actual): September 20, 2025

Study Registration Dates

• First Submitted: September 21, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: Anet 19-2/ 04-2024-300523

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No