Ventilator-induced Diaphragm DysfunctionNCT07880977
Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
A study testing Shenfu Injection and 5% glucose injection in people with Ventilator-induced Diaphragm Dysfunction and Ventilator Dependence, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence, Ventilator Weaning
- What is being tested?
- Shenfu Injection and 5% glucose injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Motor neuron disease.
- Guillain-Barré syndrome.
- Myasthenia gravis.
- Mitochondrial myopathy.
- Severe thoracic deformity.
- High cervical spinal cord injury or myelitis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
Min Li, 13588432932, 2504188@zju.edu.cn
About this study
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
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.
- Being tested
- Shenfu Injection, 5% glucose injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenfu InjectionDrug
Also called SFI
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 injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Prevention - Shenfu Injection | Experimental | 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. Receives: Drug: Shenfu Injection |
| Prevention - Placebo Control | Placebo comparator | 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. Receives: Drug: 5% glucose injection |
| Treatment - Shenfu Injection | Experimental | 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. Receives: Drug: Shenfu Injection |
| Treatment - Placebo Control | Placebo comparator | 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. Receives: Drug: 5% glucose injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization through Day 10 after initiation of the study intervention
Secondary outcomes (1)
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.
Measured: From randomization until successful ventilator weaning, assessed up to 10 days after initiation of the study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Apr 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-induced Diaphragm DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two randomized parallel-group components: a prevention component in mechanically ventilated patients and a treatment component in patients with established ventilator dependence. Within each component, eligible participants are randomly assigned to receive Shenfu Injection or control treatment.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880977
- Sponsor's protocol ID
- KY-2026-057
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No