An interventional study of Shenfu Injection and 5% glucose injection in Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence and Ventilator Weaning, sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Not applicable, Interventional, and Other
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.
The Fourth Affiliated Hospital of Zhejiang University School of Medicine is the lead sponsor of 92 studies on the registry; 78 are open to participants now.
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Exclusion Criteria:
Participants in the prevention component will receive standard clinical care plus Shenfu Injection. 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. Participants receiving mechanical ventilation for less than 70 hours will be excluded according to the study protocol. Diaphragm excursion and diaphragm thickness will be assessed daily using bedside ultrasonography.
Drug: Shenfu Injection
Participants in the prevention component will receive standard clinical care plus placebo control consisting of an equivalent amount of 5% glucose injection. The placebo will be administered twice daily according to the same treatment schedule as the Shenfu Injection group until successful ventilator weaning. Diaphragm excursion and diaphragm thickness will be assessed daily using bedside ultrasonography.
Drug: 5% glucose injection
Participants with established ventilator dependence will receive standard clinical care plus Shenfu Injection. 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, with the duration of weaning progressively increased by 3 hours per day until the participant remains successfully liberated from mechanical ventilation for more than 48 hours.
Drug: Shenfu Injection
Participants with established ventilator dependence will receive standard clinical care plus placebo control consisting of an equivalent amount of 5% glucose injection. The placebo will be administered twice daily for 10 consecutive days. Beginning on Day 3, ventilator-weaning training will be initiated, with the duration of weaning progressively increased by 3 hours per day until the participant remains successfully liberated from mechanical ventilation for more than 48 hours.
Drug: 5% glucose 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.
Also known as: SFI
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.
Percentage of Participants With Successful Ventilator Weaning
Successful ventilator weaning is defined as liberation from invasive mechanical ventilation followed by at least 48 consecutive hours without the need for reinstitution of invasive mechanical ventilation. The outcome will be reported as the percentage of participants who meet this definition during the assessment period.
Time frame: From randomization through Day 10 after initiation of the study intervention
Time to Successful Ventilator Weaning
Time from randomization to successful ventilator weaning, defined as liberation from invasive mechanical ventilation followed by at least 48 consecutive hours without reinstitution of invasive mechanical ventilation. Time will be measured in days.
Time frame: From randomization until successful ventilator weaning, assessed up to 10 days after initiation of the study intervention
Started Apr 2026 (actual). Primary completion is estimated for Aug 2027, 16 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Shen-Fu
The Fourth Affiliated Hospital of Zhejiang University School of Medicine