Predictors of Reactive Thrombocytosis in Critically Ill Septic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reactive or secondary thrombocytosis in critically ill septic patients
研究概览
简要总结
Reactive or secondary thrombocytosis is defined as abnormally high platelet count (≥4,50,000 platelets per micro-liter) in the absence of chronic myeloproliferative disease. In critically ill patients reactive thrombocytosis is not uncommon during recovery phase and an association has been seen with poor outcome and increased risk of subsequent VTE. However, not all patients with infection respond with thrombocytosis. No study has enumerated the risk factors or predictors of reactive thrombocytosis in critically ill septic patients.
详细描述
All patients admitted to intensive care unit of the department of Critical Care Medicine during one year period will be screened for possible inclusion in this study. In this prospective observational study, demographic and clinical characteristics of all ICU patients who fulfill inclusion criteria will be collected along with relevant laboratory tests done for patient management routinely. ICU prognostication scores, i.e., Acute Physiologic and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score will also be recorded. ICU survivors will be followed up in their routine ICU follow up clinic visits.
Sample size was estimated at 10% incidence rate of reactive thrombocytes, two sided 95% confidence interval and 4.5% margin of error of the incidence rate, sample size came out to be 171. Finally in this study investigators have targeted to include at least 180 participants. Sample size was estimated using software power analysis and sample size, 2008 (PASS-8).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult (≥18 years) ICU patients with the diagnosis of sepsis will be considered.
排除标准
- •Age <18 years
- •Pregnancy
- •H/O Malignancy
- •Thrombocytosis at admission
- •Primary thrombocytosis
- •Post-splenectomy
- •Chronic inflammatory disease (e.g. Connective tissue disorders, IBD, temporal arteritis)
- •Known immunosupressive condition
- •Chronic infectious diseases (e.g. tuberculosis, chronic pneumonitis)
结局指标
主要结局
Reactive or secondary thrombocytosis in critically ill septic patients
时间窗: From date of inclusion until the date of thrombocytosis or date of ICU discharge (death or alive), whichever came first, assessed up to 3 months
Reactive or secondary thrombocytosis (≥4,50,000 platelets per micro-liter) due to the sepsis
次要结局
未报告次要终点
研究者
Mohan Gurjar
Additional Professor
Sanjay Gandhi Postgraduate Institute of Medical Sciences