NCT05944445招募中不适用
The Incidence of Linezolid-induced Thrombocytopenia (LIT) in Critically Ill Patients, the Risk Factors for LIT and Time to Events (LIT, Recovery)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Incidence of Linezolid-induced thrombocytopenia (LIT) thrombocytopenia
研究概览
简要总结
- To identify the incidence of LIT among critically ill patients, as limited studies have only addressed this population.
- To evaluate the impact of several factors on the incidence of LIT, the time to onset of LIT, and the time to recovery of platelets.
- To study the effect of concurrent medications (enoxaparin, unfractinated heparin, piperacillin, carbapenems, tigecycline, fluconazole or voriconazole, digoxin, amiodarone, acetaminophen, tirofiban, statins, and antiepileptics) frequently used in critically ill patients on the incidence of LIT.
- To investigate the impact of possible medications with an antioxidant effect on the prevention of LIT.
- To assess the impact of LIT on composite end point (mortality, bleeding, and length of stay)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 patients, age > or = 18 years old, admitted to the ICU with different indications.
- •candidates for intravenous linezolid therapy for > or =1 day.
排除标准
- •Taking any myelosuppressive drug.
- •Baseline platelets <
- •Patients with hematological malignancy.
- •COVID-19 patients.
- •Patients with immune thrombocytopenia
研究组 & 干预措施
Single arm group
Adult critically ill patients admitted to ICU for different indications
干预措施: Linezolid 600 mg (Drug)
结局指标
主要结局
Incidence of Linezolid-induced thrombocytopenia (LIT) thrombocytopenia
时间窗: One year
Defined as platelets \< 150000 OR decrease \> 50% of baseline platelets.
次要结局
- Time to the onset of LIT(One year)
- time to platelet recovery(One year)
- Incidence of clinical outcomes(One year)
研究者
Mohamed Abdeltawab
Clinical pharmacist
Helwan University
研究点 (1)
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