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Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Summary
This multicenter randomized controlled trial aims to evaluate the efficacy of Shenfu Injection in preventing and treating ventilator dependence and ventilator-induced diaphragm dysfunction (VIDD) in critically ill adult patients receiving invasive mechanical ventilation. Eligible participants will be randomly assigned to receive Shenfu Injection or control treatment in addition to standard clinical care. Diaphragm function will be monitored using daily bedside ultrasonography, including diaphragm excursion and diaphragm thickness. Clinical outcomes will include successful ventilator weaning, time to successful weaning, and the need for resumption of mechanical ventilation within 48 hours after initial weaning. The study is intended to determine whether Shenfu Injection can improve diaphragm function and facilitate liberation from mechanical ventilation.
Official title: A Multicenter Randomized Controlled Trial of Shenfu Injection for the Prevention and Treatment of Ventilator Dependence and Ventilator-Induced Diaphragmatic Dysfunction in Critically Ill Patients
Key Details
Gender
All
Age Range
19 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-04-01
Completion Date
2027-08-31
Last Updated
2026-10-19
Healthy Volunteers
No
Interventions
Shenfu Injection
Shenfu Injection will be administered intravenously in addition to standard clinical care. In the prevention component, treatment will begin after more than 24 hours of mechanical ventilation and will be administered twice daily, one ampoule per administration, until successful ventilator weaning. In the treatment component for patients with established ventilator dependence, Shenfu Injection will be administered twice daily, one ampoule per administration, for 10 consecutive days. Beginning on Day 3, ventilator-weaning training will be initiated according to the study protocol.
5% glucose injection
An equivalent amount of 5% glucose injection will be administered as the placebo control in addition to standard clinical care. In the prevention component, placebo will be administered twice daily according to the same schedule as the Shenfu Injection group until successful ventilator weaning. In the treatment component for patients with established ventilator dependence, placebo will be administered twice daily for 10 consecutive days. Beginning on Day 3, ventilator-weaning training will be initiated according to the study protocol.
Locations (1)
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Yiwu, Zhejiang, China