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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06612307

Enrollment

422

Registered

2024-09-25

Start date

2024-09-25

Completion date

2025-09-20

Last updated

2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Brief summary

Leucocyte subpopulation and platelet indices analysis can predict clinical outcome

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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). * History of platelet transfusion one week before admission. * Bone marrow transplanted population on steroid therapy. * Von-Willebrand disease. * Myelodysplastic or proliferative patients. * Blood dyscarsiasis * Obestetric parturients.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and specificity of either leucocyte profiling , platelet indices with early clinical deterioration	from biomarker sampling through fifth calendar day	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) second calendar day. T0 was the biomarker sampling immediately after sepsis diagnosis. Timing of deterioration was subclassified from To to second calendar day ( any deterioration events for the first time from T0 until second calendar day after that defined as very early deterioration) or early deterioration ( from third calendar day to day-5 = any deterioration events occur for the first time only from third to the fifth calendar day inclusive after T0

Secondary

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 )

Countries

Egypt

Outcome results