Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan

The purpose of this study is to confirm the efficacy and safety of sivelestat in patients with acute lung injury associated with systemic inflammatory response syndrome. The results will be compared to the study with conventional treatment without sivelestat.

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Key information

Conditions

Acute Lung Injury Inflammation Lung Diseases Lung Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Shock Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chugoku Region Facility, Chugoku, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sivelestat sodium hydrate

Drug

0.2 mg/kg/hr continuous i.v. infusion - up to 14 days

Primary outcomes

Ventilator free days (VFD)

Time frame: 28 days

Secondary outcomes

28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores

Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Efficacy and Safety of Sivelestat Sodium Hydrate in Acute Lung Injury Associated With Systemic Inflammatory Response Syndrome, Compared With the Conventional Treatment in Japan

Important dates

Study start: 2004
Primary completion: 2007
First posted: Sep 22, 2005
Registry last updated: Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed