A multi-center, randomized controlled trial of sivelestat sodium in the treatment of ARDS caused by multiple injuries

A multi-center, randomized controlled trial of sivelestat sodium in the treatment of respiratory distress syndrome (ARDS) caused by multiple injuries

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200056205

Enrollment

Unknown

Registered

2022-02-01

Start date

2022-02-18

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

ARDS

Interventions

sivelestat sodium:sivelestat sodium in the treatment

normal saline:normal saline in the treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female, aged >= 18 years; 2. Patients are diagnosed with the diagnosis of multiple injuries; 3. Patients diagnosed with ARDS by the Berlin diagnostic criteria.

Exclusion criteria

Exclusion criteria: 1. Patients participating in other clinical studies; 2. Women in pregnancy or lactation; 3. Have chronic severe cardiac, liver or renal insufficiency; 4. Severe lung diseases, such as end-stage chronic obstructive pulmonary disease, chronic interstitial lung disease, etc.; 5. Malignant tumor; 6. PaO2/FiO2 <= 100 mmHg.

Design outcomes

Primary

Measure	Time frame
28-day case fatality rate;	—

Secondary

Measure	Time frame
Mechanical ventilation time;APACHEII score;Inflammatory cytokines;Respiratory mechanical parameter;In-hospital patient days;	—

Countries

China

Contacts

Public ContactZhang Xiaoli

Jiangdu People's Hospital, Yangzhou

64229481@163.com+86 15895700468

Outcome results

None listed

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