Shenfu Injection to help wean and reduce ventilator dependence in adults on 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
Run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · NCT07880977 · Data updated 2026-11-12
This trial tests whether Shenfu Injection, added to standard care, helps critically ill adults on invasive ventilation breathe without the machine sooner and reduces diaphragm dysfunction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 75 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Yiwu, Zhejiang) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT07880977 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 74 who require invasive mechanical ventilation and have no history of hypertension, diabetes, or allergy to traditional Chinese medicine injections.
✕Probably not a fit
Patients with motor neuron disease, Guillain-Barré syndrome, myasthenia gravis, mitochondrial myopathy, severe thoracic deformity, or high cervical spinal injuries may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized trial enrolls adults on invasive mechanical ventilation to receive Shenfu Injection in addition to standard care or a control. Diaphragm function will be monitored daily with bedside ultrasound, assessing excursion and thickness. Primary goals include faster successful ventilator weaning and a lower need to resume ventilation within 48 hours after initial weaning. The study aims to determine if Shenfu can improve diaphragm performance and shorten dependence on mechanical ventilation.
Why it matters
Potential benefit: If successful, Shenfu Injection could shorten time on ventilation and improve diaphragm function for critically ill patients.
How similar studies have gone: Prior studies in related approaches have shown signals of benefit, but this specific Shenfu-based strategy in ventilator weaning is investigational.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Critically ill patients requiring mechanical ventilation. * Age \>18 years and \<75 years. * No history of hypertension or diabetes mellitus. * No history of allergy to traditional Chinese medicine injections. Exclusion Criteria: * Motor neuron disease. * Guillain-Barré syndrome. * Myasthenia gravis. * Mitochondrial myopathy. * Severe thoracic deformity. * High cervical spinal cord injury or myelitis.
Where it's running
-
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Yiwu, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Min Li
- Email: 2504188@zju.edu.cn
- Phone: +8613588432932
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.