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A prospective, single-center, randomized controlled clinical trial of siverestanat in the treatment of severe pulmonary ARDS

A prospective, single-center, randomized controlled clinical trial of siverestanat in the treatment of severe pulmonary ARDS

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078686
Enrollment
Unknown
Registered
2023-12-15
Start date
2024-01-01
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

acute respiratory distress syndrome

Interventions

Experimental group:Silverestana0.2mg/kg/h Venous pumping
control group:Normal saline

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years old (2) It meets the diagnostic criteria of ARDS Berlin. (3) ARDS caused by pulmonary factors (4) Oxygenation index =100mmHg (5) Diagnosis of ARDS < 72 hours

Exclusion criteria

Exclusion criteria: (1) Pregnant women, breastfeeding women (2) ARDS caused by extrapulmonary factors (3) Brain death (4) End-stage tumors or other diseases (5) Treatment was abandoned after admission to ICU, and mechanical ventilation and cardiopulmonary resuscitation were not agreed (6) Severe chronic lung disease (combined with chronic respiratory failure) (7) Combined with congestive heart failure (8) Respiratory and cardiac arrest (9) Severe hemodynamic instability (10) Refuse to participate in this study or have participated in other researchers (11) Hospice (12) Extra-pulmonary SOFA=6 points (13) Ulinastatin, thymphatin and Xuebijing were used within 72 hours before enrollment (14) Glucocorticoid use =1mg/kg/ day within 7 days before enrollment (15) Known allergy to cilvelestat sodium or excipients or to other substances covered by the examination (16) Participants who had used an IL-6 antagonist (such as tocilizumab) or a JAK inhibitor in the previous week were enrolled

Design outcomes

Primary

MeasureTime frame
Oxygenation index improvement rate on day 8;

Secondary

MeasureTime frame
Improvement rate of inflammation index on day 8;On day 8, the proportion of ARDS grading improvement;Mechanical ventilation withdrawal time;28-day all-cause fatality rate;In-hospital mortality;Incidence of hospital feeling;Safety index;Pharmacoeconomic indicators (ICU hospitalization costs, drug costs);

Countries

China

Contacts

Public ContactGuo Chenxia

Peking University Third Hospital

710237955@qq.com+86 188 1177 1533

Outcome results

None listed

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