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

NCT06612307 | Completed

• 1 other identifier: Anet 19-2/ 04-2024-300523
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

Leucocyte subpopulation and platelet indices analysis can predict clinical outcome

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Menofyia

Menofyia, Menofia, Egypt

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 25, 2024
• Study Start: September 25, 2024
• Primary Completion: September 15, 2025
• Study Completion: September 20, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

EG (1)