Health Condition 1: null- Severe Sepsis
Conditions
Interventions
Intervention1: Ulinastatin: Ulinastatin will be administered in a dose of 200,000 IU (dissolved in 100 ml of 0.9% saline or 5 % dextrose) given IV over one hour every 12 hours along with standard supp
Sponsors
Lupin Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females of age >=18 years and 2. Infection: Proved or suspected infection in at least one site: • lung • abdomen • genitourinary tract • other (blood, skin and soft tissue, central nervous system, bones and joints, cardiac system, catheter related infection) 3. Modified SIRS Criteria: Patient has to meet at least three of the following four criteria: • A core temperature of >= 38º C (100.4º F) or • Heart rate of >=90 beats/min, except in patients with a medical condition known to increase the heart rate or those receiving treatment that would prevent tachycardia. • Respiratory rate >=20 breaths/min or PaCO2 of • A white cell count of >=12,000/mm3 or 10% immature neutrophils. 4. Criteria for Dysfunctional Organs or Systems: Patient has to meet at least one of the following six criteria: • For cardiovascular system dysfunction, the arterial systolic blood pressure (SBP) has to be =90 mmHg or a mean arterial pressure of >=70 mmHg. • For kidney dysfunction, urine output has to be • For respiratory dysfunction, the ratio of partial pressure of oxygen in arterial blood (PaO2) to fraction of inspired oxygen (FiO2) has to be • For hematologic dysfunction, the platelet count has to be • In the case of unexplained metabolic acidosis, the pH has to be = 5.0 mmol/L in association with a plasma lactate level that is >1.5 times the upper limit of the normal (ULN) value for the reporting laboratory. • For hepatic dysfunction, total bilirubin >1.5 mg/dL and/or Alanine Transaminase (ALT)/Aspartate Transaminase (AST) >3 times the upper limit of the normal value for the reporting laboratory. 5. Written informed consent by subject or LAR.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: 1. Patient with platelet count 2. Conditions that increase the risk of bleeding. 3. Patientâ??s family, physician, or both not in favour 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. History of bone marrow, lung, liver, pancreas or small-bowel transplantation. 6. Patients with incurable malignancies with documented metastases. 7. Chronic renal failure requiring haemodialysis or peritoneal dialysis. 8. Known or suspected portosystemic hypertension, chronic jaundice, cirrhosis or chronic ascites. 9. Deep seated fungal infection or active tuberculosis. 10. History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease. 11. Neuromuscular disorders that impact breathing/spontaneous ventilation. 12. Quadriplegia. 13. Cardiac arrest in the past 30 days. 14. New York Heart Association functional Class III and IV due to heart failure or any disorder. 15. Burns over >30% of body surface area. 16. Allergy for Ulinastatin. 17. Pregnant or lactating females or females of child bearing potential who are not willing for using adequate methods of contraception. 18. Participation in another clinical study within 30 days prior to the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the average length of hospital stay (days) 2.Percentage of subjects achieving subsidence of sepsis 3.Percentage of subjects achieving prevention of new onset organ failure 4.To assess the duration of ventilation, if any 5.Assessment of safety of Ulinastatin in terms of incidence of treatment emergent adverse events (TEAE).Timepoint: Day 28 or discharge day from Hospital, whichever is earlier | — |
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with reduction in mortality rateTimepoint: Day 28 | — |
Countries
India
Contacts
Public ContactDr Chirag Shah
Lupin Limited
Outcome results
None listed