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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001555

Enrollment

Unknown

Registered

2011-09-09

Start date

2006-03-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

acute lung injury associated with systemic inflammatory response syndrome

Interventions

control group:conventional therapy+Placebo

treatment group:conventional therapy+sivelestat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18-75years old,both male and female; 2. Patients with systemic inflammatory response syndrome (SIRS); 3. Patients with acute lung injury (ALI) assessed using the criteria specified by the American-European Consensus Conference; 4. have not be in other trials for at least 3 months; 5. informed consent; 6. be on mechanical ventilation.

Exclusion criteria

Exclusion criteria: 1. Patients complicated with 4 or more multiple organ failure including lung failure; 2. According to MODS,either of below: (1) PaO2/FiO2<100 mmHg; (2) There are two values of organs or systems both beyond 2; 3. Congestive heart failure,diffuse pulmonary infection, severe systemic infection and other diseases may confusing diagnosis; 4. Other exclusion criteria as specified in the protocol.

Design outcomes

Primary

Measure	Time frame
Lung injury score;	—

Secondary

Measure	Time frame
survival;ICU free days and ICU free rate;ventilation free days and rate;SIRS Symptom and sign;	—

Countries

China

Contacts

Public ContactChunxue Bai MD & PhD,

bai.chunxue@zs-hospital.sh.cn+86 021 64041990-3077

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026