Health Condition 1: R652- Severe sepsis
Conditions
Interventions
Intervention1: U-tryp: Dose: 200,000 IU bd x 5 days
Total duration of therapy - 5 days
Control Intervention1: Placebo: 200000 IU bd x 5 days
Total duration of therapy - 5 days
Sponsors
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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: 1. Fever 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
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breast-feeding 2. Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 28-day mortality 2. Length of hospital stay (days) Timepoint: 1. 28-day mortality 2. Length of hospital stay (days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Length of ICU stay (days) 2. 90-Day Mortality 3. Incidence of new onset organ failure 4. Duration of assisted ventilation, if any. Timepoint: 1. when shifted out of ICU 2. Day 90 3. Any time during the study period 4. any time during the study period | — |
Countries
India
Contacts
Public ContactDr Ganesh Divekar
Bharat Serums and Vaccines Ltd
Outcome results
None listed