Health Condition 1: R652- Severe sepsis
Conditions
Interventions
Intervention1: Ulinastatin: 200000IU b.d. X 5 days
Control Intervention1: Placebo: b.d. x 5 days
Sponsors
Bharat Serums and Vaccines Limited
Eligibility
Inclusion criteria
Inclusion criteria: I. Age >18yrs 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
Exclusion criteria
Exclusion criteria: 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 (&#8804; 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 28 day mortality 2. Prevention of new onset organ failure 3. Improvement of hemodynamics, i.e., time to stoppage of vasopressors Timepoint: Day 5, discharge and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 scoresTimepoint: Day 5, discharge and Day 28 | — |
Countries
India
Contacts
Public ContactMs Naju Turakhia
Jupitar Hospital
Outcome results
None listed