Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients

Description

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.

Interventions

• Shenfu Injection (Drug)
  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 (Drug)
  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.

Eligibility criteria

Conditions

Locations

• The Fourth Affiliated Hospital, Zhejiang University School of Medicine — Yiwu, Zhejiang, China