CTRI/2009/091/000650已完成3 期
A prospective, multicentric, double-blind, randomised, phase III clinical study to compare the efficacy and safety of intravenous Ulinastatin versus placebo alongwith standard supportive care in subjects of severe sepsis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 7
- 主要终点
- 1. 28 day mortality 2. Prevention of new onset organ failure3. Improvement of hemodynamics, i.e., time to stoppage of vasopressors
研究概览
简要总结
The study is a randomised, placebo controlled double-blind study to determine the efficacy and safety of Ulinastatin as adjuvant therapy in severe sepsis at a dose of 200000IU b.d. for 5 days. The anti-inflammatory and anti-oxidative action of Ulinastatin would decrease the mortality and progression of disease. The efficacy endpoints are reduction in mortality, Prevention of new onset organ failure, Improvement of hemodynamics ie time to stoppage of vasopressors and shorter hospitalisation
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age >18yrs <60yrs (both inclusive) & weight <135kg II.
- •Patient has to have a known infection or a suspected infection, as evidenced by one or more of the following:
- •Perforated viscus
- •Radiographic evidence of pneumonia in association with the production of purulent sputum
- •A syndrome associated with a high risk of infection (e.g., ascending cholangitis) III.
- •Modified SIRS criteria IV.
- •One dysfunctional organ / system.
排除标准
- •Pregnancy or breast-feeding
- •Age < 18yr or weight > 135 kg
- •Platelet count < 30,000/mm3.
- •Conditions that increase the risk of bleeding
- •Moribund state in which death was perceived to be imminent (≤ 24 hours)
- •Chronic renal failure requiring hemodialysis or peritoneal dialysis
- •Known or suspected portosystemic hypertension, chronic jaundice, cirrhosis or chronic ascites
- •Participation in another investigational study within 30 days before the current study.
结局指标
主要结局
1. 28 day mortality 2. Prevention of new onset organ failure3. Improvement of hemodynamics, i.e., time to stoppage of vasopressors
时间窗: Day 5, discharge and Day 28
次要结局
- 1. Percentage of subjects achieving subsidence of sepsis (microbiological and clinical). 2. Average length of hospital stay (days) till discharge in survivors. 3. Duration of assisted ventilation, if any.4. Reduction in APACHE II scores(Day 5, discharge and Day 28)
研究者
研究点 (7)
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