Clinical study on the effect of Qingfei Huayu Tongfu recipe on regulating alveolar epithelial-mesenchymal transition in mechanically ventilated patients with sepsis-related ARDS

Not Applicable

Recruiting

• Conditions: sepsis-related acute respiratory distress syndrome

• Registration Number: ITMCTR2024000190
• Lead Sponsor: Jiangsu Provincial Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Those who meet the diagnostic criteria for sepsis and ARDS and the TCM syndrome differentiation criteria of blood stasis and heat congesting the lungs and viscera-qi obstruction.
2. Aged between 18 and 80 years old, regardless of gender.
3. Acute onset, duration of disease within 2 days.
4. Give informed consent and volunteer to be tested. The process of obtaining informed consent should comply with GCP regulations.

Exclusion Criteria

1. Already participated in other clinical trials.
2. Pregnancy or lactation.
3. Cancer patients with disseminated tumors or receiving chemotherapy and other special treatments.
4. Severe liver function abnormalities (TBIL = 171 µmmol/L or daily increase = 17.1 µmmol/L).
5. Severe renal dysfunction (Scr increases by more than 26.5 µmmol/L or 1.5 times the baseline value within 48 hours, or urine output is <0.5 ml/kg/h, lasting for more than 6 hours).
6. Unstable angina/acute myocardial infarction, heart rate <50 beats/min, second degree or above conduction block;
7. Use of 2 vasoactive drugs within 2 hours before the start of the study and the systolic blood pressure is still <90mmHg.
8. For gastrointestinal dysfunction, traditional Chinese medicine cannot be administered through the gastrointestinal tract.
9. Those who are allergic to Chinese medicine or intolerant to Chinese medicine.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxygenation index;

Secondary Outcome Measures

Name	Time	Method
Ventilator-related parameters (tidal volume, respiratory rate, positive end-expiratory pressure, peak airway pressure, plateau pressure, driving pressure);ß-catenin\GSK3ß;E-cadherin;