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

Bharat Serums and Vaccines Limited0 个研究点目标入组 122 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•I. 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:
•1. White cells in a normally sterile body fluid
•2. Perforated viscus
•3. Radiographic evidence of pneumonia in association with the production of purulent sputum
•4. A syndrome associated with a high risk of infection (e.g., ascending cholangitis)
•III. Modified SIRS criteria
•IV. One dysfunctional organ / system

•1. Pregnancy or breast-feeding
•2. Age < 18yr or weight > 135 kg
•3. Platelet count < 30,000/mm3.
•4. Conditions that increase the risk of bleeding
•5. Moribund state in which death was perceived to be imminent (≤ 24 hours)
•6. History of bone marrow, lung, liver, pancreas or small-bowel transplantation
•7. Chronic renal failure requiring hemodialysis or peritoneal dialysis
•8. Known or suspected portosystemic hypertension, chronic jaundice, cirrhosis or chronic ascites
•9. Participation in another investigational study within 30 days before the current study

发起方