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Completed

NCT Number: NCT06612307

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

Leucocyte subpopulation and platelet indices analysis can predict clinical outcome

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mina Maher Raouf

Minya, 61511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sensitivity and specificity of either leucocyte profiling , platelet indices with early clinical deterioration

    Time frame: 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 outcomes

  1. association between leucocytes at enrollment with ICU mortality

    Time frame: 2 weeks ( during ICU admission)

  2. association between platelet indices at enrollment with ICU mortality

    Time frame: 2 weeks (during ICU admission)

  3. association between platelet indices at enrollment with incidence of mechanical ventilation

    Time frame: 2 weeks

  4. association between leucocytes at enrollment with incidence of mechanical ventilation

    Time frame: 2 weeks (during ICU admission)

  5. association between leucocytes at enrollment , with incidence of acute kidney injury

    Time frame: 2 weeks (during ICU admission)

  6. association between platelet indices at enrollment with incidence of acute kidney injury

    Time frame: 2 weeks (during ICU admission )

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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