2024-515776-12-00已完成2 期
Epirubicin for the Treatment of Sepsis & Septic Shock
Friedrich-Schiller-Universitaet Jena, Friedrich-Schiller-Universitaet Jena5 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年10月1日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Safety as assessed by myelotoxicity until day 14 is the primary endpoint.
研究概览
简要总结
To assess safety of low-dose epirubicin as an adjunctive therapy for patients with sepsis and septic shock.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Written informed consent of subject or its authorized representative or legal representative or confirmation of the urgency of participation in the clinical trial and the possible benefit to the subject by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing center to include subjects who are unable to provide informed consent.
- •Patients >18 years with sepsis or septic shock, currently hospitalized at the ICU or IMC regardless where the sepsis was first diagnosed
- •Sepsis diagnosis, as currently defined, within 48 hours prior to screening regardless of site of infection.
排除标准
- •Leukopenia/Neutropenia/Thrombocytopenia-prior or upon inclusion (Leukocyte Count <4,000/µL; Neutrophil/Thrombocyte Count below Lower Limit of Normal)
- •Acute liver failure following the European Association for the Study of the Liver definition as International Normalized Ratio (INR) >1.5 and elevation of transaminases >= 3 times of the upper normal limit (European Association for the Study of the Liver. Electronic address et al., 2017).
- •Pregnancy during all trimester/breast-feeding.
- •Chronic mechanical ventilation dependency.
- •Cystic fibrosis.
- •Concomitant medication with Verapamil or Cimetidine.
- •Prior enrollment in this study.
- •Participation in another clinical intervention trial.
- •Weight >135 kg/BMI >
- •Ongoing or History of chemotherapy.
- •Hypersensitivity to epirubicin.
- •History of bone marrow or solid organ transplantation.
- •Immunosuppressive therapy.
- •Acute severe infection within 4 weeks prior to admission (Hospitalization for an infection or in case of hospital acquired infection transfer to a higher level of care due to the infection)
- •Chronic infection.
- •Cardiomyopathy with a documented ejection fraction <30% or ICD implantation.
结局指标
主要结局
Safety as assessed by myelotoxicity until day 14 is the primary endpoint.
Safety as assessed by myelotoxicity until day 14 is the primary endpoint.
次要结局
- Occurrence of Cardiotoxicity.
- Survival at day 14, 28 and 90.
- Degree of organ dysfunction measured by SOFA score.
- Occurrence of Adverse Events.
- SOFA “Success” rate defined as a decrease of procalcitonin (PCT) serum concentration by 80% or more of its intra-individual peak value or to 0.5 μg/L or lower within 72 hours after randomization.
研究者
Prof. Sebastian Weis
Scientific
Friedrich-Schiller-Universitaet Jena
研究点 (5)
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