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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219375

Enrollment

649

Registered

2005-09-22

Start date

2004-06-30

Completion date

Unknown

Last updated

2015-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury, Systemic Inflammatory Response Syndrome

Keywords

sivelestat sodium hydrate, acute lung injury, systemic inflammatory response syndrome, Elaspol, Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS)

Brief summary

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.

Interventions

DRUGSivelestat sodium hydrate

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with systemic inflammatory response syndrome (SIRS) 2. Patients with acute lung injury (ALI) assessed using the criteria specified by the American-European Consensus Conference 3. Within 72 hours of onset of lung injury 4. Other inclusion criteria as specified in the protocol

Exclusion criteria

1. Already administrated Sivelestat before enrollment in the study 2. Neuromuscular disease that impairs spontaneous ventilation 3. Severe central nervous system disease 4. Bone marrow transplant 5. Lung transplant 6. Severe chronic liver disease 7. Neutropenia (neutrophil count: below 1000/mm3) 8. Other

Design outcomes

Primary

Measure	Time frame
Ventilator free days (VFD)	28 days

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026