A prospective, multicenter, double-blind, randomized controlled trial of the safety and efficacy of Civelestat sodium in the treatment of sepsis patients with mild to moderate ARDS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200056892

Enrollment

Unknown

Registered

2022-02-22

Start date

2022-03-15

Completion date

Unknown

Last updated

2023-09-18

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

Conditions

Sepsis with mild to moderate acute respiratory distress syndrome (ARDS)

Interventions

Experimental group:Civelestat sodium for injection

Control group:Adjuvant placebo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. No gender limit, aged between 18 and 75 years; 2. Patients diagnosed with sepsis according to SEPSIS 3.0; 3. Patients diagnosed with ARDS according to the Berlin ARDS diagnostic criteria; 4. Patients who were able to administer medication within 48 hours after admission to the ICU to patients diagnosed with ARDS; 5. Be able to understand and comply with the requirements of the agreement and participate in this study voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients participating in other clinical studies; 2. Patients with serious lack of diagnosis and treatment data; 3. Pregnant or lactating patients or patients who may be pregnant; 4. Patients deemed unsuitable for the study group by the investigator (such as organs with chronic diseases such as severe liver and kidney function injury, chronic emphysema, respiratory failure, after transplantation, DIC patients, end-stage cancer patients, patients with mental diseases, etc.); 5. Patients with oxygenation index PaO2/FiO2 80mg/ day) for more than 5 days; 8. Patients deemed unsuitable for this study by the physician; 9. Patients for whom effective treatment of the primary disease is not available.

Design outcomes

Primary

Measure	Time frame
Oxygenation index;Mode and time of breathing support;Plasma neutrophil elastase levels;	—

Secondary

Measure	Time frame
C-reactive protein content in blood and alveolar lavage fluid;Procalcitonin levels in blood and alveolar lavage fluid;Interleukin-6 levels in blood and alveolar lavage fluid;Interleukin-8 levels in blood and alveolar lavage fluid;Interleukin-10 levels in blood and alveolar lavage fluid;TNF-a levels in blood and alveolar lavage fluid;BUN levels in lung lavage fluid;Protein content of lung lavage fluid;Lung compliance;Breathing machine PEEP;28-day survival rate;	—

Measure

Time frame

C-reactive protein content in blood and alveolar lavage fluid;Procalcitonin levels in blood and alveolar lavage fluid;Interleukin-6 levels in blood and alveolar lavage fluid;Interleukin-8 levels in blood and alveolar lavage fluid;Interleukin-10 levels in blood and alveolar lavage fluid;TNF-a levels in blood and alveolar lavage fluid;BUN levels in lung lavage fluid;Protein content of lung lavage fluid;Lung compliance;Breathing machine PEEP;28-day survival rate;

—

Countries

China

Contacts

Public ContactWu Tiejun

Liaocheng People's Hospital

tiejunwu@hotmail.com+86 13306352913

Outcome results

None listed

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