A Phase IV, Prospective, Multicentric, Double-blind, Comparative, Clinical Study To Compare The Efficacy And Safety Of Intravenous Ulinastatin versus Placebo along with Standard Supportive Care In Subjects With Severe Sepsis

Bharat Serums and Vaccines Ltd0 sites0 target enrollmentStarted: TBDLast updated: July 22, 2024

Trial Snapshot

No summary available.

•1) Age between 18 years and 65 years (both inclusive)
•2) Infection Criteria:
•Patient should have a known infection or a suspected infection, as evidenced by one or more of the following:
•a)White cells
•b)Perforated viscus
•c)Pneumonia
•d)Bacterial infection
•e)Other infections
•3) Modified SIRS Criteria:
•Patient has to meet two of the following four criteria:
•2.Abnormal heart rate
•3.Abnormal respiratory rate
•4.Abnormal white cell count
•4) Criteria for Severe sepsis:
•Patient has to meet at least one of the following nine criteria
•1.Abnormal blood pressure
•2.Abnormal Urine output
•3.Abnormal Creatinine
•4.Acute lung injury
•5.Acute lung injury with pneumonia
•6.Abnormal lactate level
•7.Abnormal total bilirubin
•8.Abnormal platelet count
•9.Coagulopathy

•1.Pregnancy or breast-feeding
•2. Age < 18yr or > 65 years
•3. Patient’s family, physician, or both not in favor of aggressive treatment of patient or presence of an advanced directive to withhold life-sustaining treatment
•4. Patient not expected to survive 28 days because of uncorrectable medical condition, such as poorly controlled neoplasm or other end stage disease.
•5. Moribund state in which death is perceived to be imminent (= 24 hours)
•6. History of bone marrow, lung, liver, pancreas or small-bowel transplantation
•7. Participation in any other investigational study within 30 days before the current study

Sponsor

Bharat Serums and Vaccines Ltd