linastatin in Severe Sepsis

Phase 3

Completed

• Conditions: Health Condition 1: R652- Severe sepsis

• Registration Number: CTRI/2009/091/000650
• Lead Sponsor: Bharat Serums and Vaccines Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-06-10
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 122

Inclusion Criteria

I. 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. 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified