Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan
Acute Lung Injury, Systemic Inflammatory Response Syndrome
About this trial
This is an interventional treatment trial for Acute Lung Injury focused on measuring sivelestat sodium hydrate, acute lung injury, systemic inflammatory response syndrome, Elaspol, Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS)
Eligibility Criteria
Inclusion Criteria: Patients with systemic inflammatory response syndrome (SIRS) Patients with acute lung injury (ALI) assessed using the criteria specified by the American-European Consensus Conference Within 72 hours of onset of lung injury Other inclusion criteria as specified in the protocol Exclusion Criteria: Already administrated Sivelestat before enrollment in the study Neuromuscular disease that impairs spontaneous ventilation Severe central nervous system disease Bone marrow transplant Lung transplant Severe chronic liver disease Neutropenia (neutrophil count: below 1000/mm3) Other exclusion criteria as specified in the protocol
Sites / Locations
- Chubu Region Facility
- Chugoku Region Facility
- Hokkaido Region Facility
- Hokuriku Regional Facility
- Kanto Regional Facility
- Kinki Region Facility
- Kyushu Region Facility
- Shikoku Region Facility
- Tohoku Region Facility
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
No Intervention
E1
E2
conventional therapy
This arm is conducted as a separate study (12-601-0001)
This arm is conducted as a separate study (12-603-0001).
This arm is conducted as a separate study (12-602-0001)