CTRI/2012/11/003144已完成4 期
A Prospective Multi-Centric Double-Blind Randomized Phase IV Clinical Trial To Compare The Efficacy And Safety Of Ulinastatin Versus Placebo Along With Standard Supportive Care In Prevention Of Multiple Organ Dysfunction Syndrome due to worsening of Sepsis In Patients With Moderate to Severe Injury
Bharat Serums and Vaccines Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •I. Age >18yrs <65yrs (both inclusive)
- •II. Patients with potentially life threatening injury (ISS >= 9 and RTS >= 6)
- •III. Drug administration should commence within 24 hours of injury
- •IV. Evidence of SIRS and/or sepsis
排除标准
- •Pregnant or breast-feeding.
- •2. Age < 18yrs or >65yrs.
- •3. Very severe injury wherein patient is unlikely to survive till the end of Investigational Product.
- •4. Patients with severe head injury (Glasgow Coma Scale <= 8)
- •5. Known case of major co-morbid (medical) illnesses.
- •6. Known case of chronic cardiac, kidney, lung or liver disease.
- •7. Known case of immunocompromised / Immunosuppressed status.
- •8. Participation in another investigational study within 30 days before thecurrent study.
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