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A Single-Center Prospective Observational Cohort Study on the Safety and Efficacy of Sodium Sivelestat in the Treatment of Primary or Secondary Brain Injury with ARDS

A Single-Center Prospective Observational Cohort Study on the Safety and Efficacy of Sodium Sivelestat in the Treatment of Primary or Secondary Brain Injury with ARDS

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108494
Enrollment
Unknown
Registered
2025-09-01
Start date
2025-09-10
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

ARDS associated with traumatic brain injury

Interventions

Observation group:None
Control group:None

Sponsors

Mianyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 70 years old> = age>=18 years old, gender/ethnicity is not limited; 2. CT or MRI scan shows intracranial hemorrhage, intracranial soft tissue injury, brain contusion and laceration, skull fracture, cerebral edema; 3. Admission diagnosis of ARDS, ARDS meets the 2023 global newly defined diagnostic criteria (Appendix 1); 4. Volunteer to participate in this clinical trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who are participating in other exploratory clinical studies at the same time; 2. Pulmonary edema is mainly attributable to cardiogenic pulmonary edema/fluid overload; 3. Hypoxemia/abnormal gas exchange is mainly attributable to atelectasis; 4. Pregnant, lactating women or women who may be pregnant; 5. Patients or family members refuse to sign informed consent; 6. Allergy to experimental drugs; 7. Severe chronic respiratory diseases: autoimmune diseases involving the lungs, chronic respiratory failure, such as moderate to severe chronic obstructive pulmonary disease (FEV1<70%pred or clinically judged to have obvious airway obstructive disease), bronchiectasis or pulmonary interstitial fibrosis (area of more than 20% lung volume); Patients with diaphragm or respiratory muscle weakness; 8. Patients with advanced tumors or cachexia (expected survival not more than 3 months); 9. Patients with multiple organ failure involving four or more organs (including lung, heart, liver, kidney, gastrointestinal system (bleeding), central nervous system, and coagulation system); 10. Bone marrow transplantation; lung transplantation; or patients with severe chronic liver disease; 11. Patients with neutropenia.

Design outcomes

Primary

MeasureTime frame
Oxygenation index PaO2/FiO2;

Secondary

MeasureTime frame
Interleukin-6;C-reactive protein;Procalcitonin;Chest imaging;Brain imaging;28 days without ventilator support;28 days Survival rate;

Countries

China

Contacts

Public ContactXu Zhihua

Mianyang Central Hospital

yokiku163@163.com+86 138 9019 9910

Outcome results

None listed

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