Sensitivity and Specificity of Leucocytes Subpopulation Versus Platelet Indices in Prediction of Clinical Outcome for Candidates With Sepsis. A Bi-centric Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 422
- 试验地点
- 1
- 主要终点
- Sensitivity of either leucocyte subpopulation, platelet indices with early clinical outcome
研究概览
简要总结
Leucocyte subpopulation and platelet indices analysis can predict clinical outcome
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Sensitivity of either leucocyte subpopulation, platelet indices with early clinical outcome
时间窗: 1 week
Post hoc analysis .... \< 50 %= poor sensitivity..... \> 50%= strong sensitivity
Specificity of either leucocyte subpopulation, platelet indices with early clinical outcome
时间窗: 1 week
Post hoc analysis .... \< 50 %= poor sensitivity..... \> 50%= strong sensitivity
Sensitivity and specificity of either leucocyte profiling , platelet indices with early clinical deterioration
时间窗: 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
次要结局
- 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)
- 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 ))
研究者
Mina Maher
principal investigator
Minia University