Health Condition 1: null- Severe Sepsis Health Condition 2: R652- Severe sepsis
Conditions
Interventions
Intervention1: U-Tryp (ulinastatin): 200,000 IU (dissolved in 100 ml of 0.9% saline) given IV over one hour every 12 hours for 5 days along with standard supportive care
Control Intervention1: Placeb
Sponsors
BHARAT SERUMS AND VACCINES LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1 Inclusion Criteria The following criteria should be checked at the time of study entry: 1) Age between 18 and 75 years (both inclusive) & weight 2) Infection Criteria: Patient has to have a known infection or a suspected infection, as evidenced by one or more of the following: a) White cells in a normally sterile body fluid b) Perforated viscous c) Radiographic evidence of pneumonia in association with the production of purulent sputum d) A condition associated with a high risk of bacterial infection (e.g., ascending cholangitis). Restrict only to bacterial sepsis. DONOT include ARDS cases due to malaria, dengue or leptospirosis 3) Modified SIRS Criteria: Patient has to meet at least three of the following four Criteria: a) A core temperature of >= 38º C (100.4º F) or b) 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 c) Respiratory rate >= 20 breaths/min or PaCO2 of d) A white cell count of >= 12,000/mm3 or 10 percent immature neutrophils. 4) Criteria for Dysfunctional Organs or Systems: Patients has to meet at least one of the following five criteria a) For cardiovascular system dysfunction, the arterial systolic blood pressure has to be = 90 mm Hg or a mean arterial pressure of >= 70 mm Hg. b) For kidney dysfunction, urine output has to be c) For respiratory dysfunction, the ratio of PaO2 to FiO2 has to be d) For hematologic dysfunction, the platelet count has to be e) In the case of unexplained metabolic acidosis, the pH has to be = 5.0 mmol/liter in association with a plasma lactate level that is > 1.5 times the upper limit of the normal value for the reporting laboratory. f) For hepatic dysfunction, total bilirubin > 1.5 mg/dL and/or ALT/AST >3 times the upper limit of the normal value for the reporting laboratory
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breast-feeding. 2. Age less than 18 years or more than 75 years or weight 135 kg. 3. Platelet count 30,000/mm3. 4. Conditions that increase the risk of bleeding. 5. Patientâ??s family, physician, or both not in favor of aggressive treatment of patient or presence of an advanced directive to withhold life-sustaining treatment. 6. Patient not expected to survive 28 days because of uncorrectable medical condition, such as poorly controlled neoplasm or other end stage disease. 7. Moribund state in which death was perceived to be imminent. ( 8. History of bone marrow, lung, liver, pancreas or small-bowel transplantation. 9. Chronic renal failure requiring hemodialysis or peritoneal dialysis. 10. Known or suspected portosystemic hypertension, chronic jaundice, cirrhosis or chronic ascites 11. Participation in another investigational study within 30 days before the current study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevention of new onset organ failure 2. Duration of assisted ventilation, if any. 3. Percentage of subjects achieving subsidence of sepsis (evidence by normalization of heart rate, respiratory rate and core body temperature). Timepoint: till discharge | — |
Primary
| Measure | Time frame |
|---|---|
| 1. 28-day mortality 2. Average length of hospital stay (days) till discharge in survivors. Timepoint: 1. 28-day mortality 2. Average length of hospital stay (days) till discharge in survivors. | — |
Countries
India
Contacts
Public ContactNaju Turakhia
Jupiter Hospital
Outcome results
None listed