Ulinastatin in Severe Sepsis
- Conditions
- Severe sepsis,
- Registration Number
- CTRI/2009/091/000650
- Lead Sponsor
- Bharat Serums and Vaccines Limited
- Brief Summary
The study is a randomised, placebo controlled double-blind study to determine the efficacy and safety of Ulinastatin as adjuvant therapy in severe sepsis at a dose of 200000IU b.d. for 5 days. The anti-inflammatory and anti-oxidative action of Ulinastatin would decrease the mortality and progression of disease. The efficacy endpoints are reduction in mortality, Prevention of new onset organ failure, Improvement of hemodynamics ie time to stoppage of vasopressors and shorter hospitalisation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 122
- Age >18yrs <60yrs (both inclusive) & weight <135kg II.
- Patient has to have a known infection or a suspected infection, as evidenced by one or more of the following: 1.
- 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.
- Pregnancy or breast-feeding2.
- Age < 18yr or weight > 135 kg3.
- Platelet count < 30,000/mm3.4. Conditions that increase the risk of bleeding5.
- Moribund state in which death was perceived to be imminent (≤ 24 hours)6.
- Chronic renal failure requiring hemodialysis or peritoneal dialysis8.
- Known or suspected portosystemic hypertension, chronic jaundice, cirrhosis or chronic ascites9.
- Participation in another investigational study within 30 days before the current study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. 28 day mortality 2. Prevention of new onset organ failure3. Improvement of hemodynamics, i.e., time to stoppage of vasopressors Day 5, discharge and Day 28
- Secondary Outcome Measures
Name Time Method 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 scores Day 5, discharge and Day 28
Trial Locations
- Locations (7)
V. M. Medical College & Safdarjung Hospital
🇮🇳Delhi, DELHI, India
B Y L Nair Hospital & T N Medical College
🇮🇳Mumbai, MAHARASHTRA, India
Bhatia Hospital
🇮🇳Mumbai, MAHARASHTRA, India
JCDC Pvt Ltd. Jahangir Hospital
🇮🇳Pune, MAHARASHTRA, India
Lokmanya Tilak Muncipal General Hospital & Lokmanya Tilak Muncipal Medical College
🇮🇳Mumbai, MAHARASHTRA, India
Maulana Azad Medical College
🇮🇳Delhi, DELHI, India
N.D.M.V.P. Samaj Medical College
🇮🇳Nashik, MAHARASHTRA, India
V. M. Medical College & Safdarjung Hospital🇮🇳Delhi, DELHI, IndiaDr P K VermaPrincipal investigator01126165032prateekverma88@hotmail.com