NCT05874700

A Pilot Study of Sivelestat Sodium to Shorten Mechanical Ventilation in Acute Aortic Dissection

A Pilot Study of Perioperative Application of Sivelestat Sodium in Acute Type A Aortic Dissection Patients With Preoperative Moderate to Severe Hypoxemia to Shorten the Duration of Postoperative Invasive Mechanical Ventilation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xiaotong Hou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is A prospective, randomized, placebo-controlled, reestimable adaptive clinical study to evaluate the efficacy and safety of perioperative application of sivelestat sodium to shorten the duration of postoperative invasive mechanical ventilation in acute type A aortic dissection patients with preoperative moderate and severe hypoxemia (PaO2/FiO2≤200mmHg).

Detailed description

In recent years, sivelestat sodium therapy has been used to treat and prevent CPB-associated lung injury with good results. Morimoto K et al., randomized control of a small sample size, demonstrated that sivelestat sodium improves respiratory function in patients with severe respiratory failure after hypothermia thoracic aortic surgery. A retrospective study by Morimoto N et al. confirmed that prophylactic application of sivelestat sodium at the beginning of CPB could improve postoperative respiratory function and shorten the duration of mechanical ventilation in patients with hypothermic circulatory arrest. At present, there is a lack of reliable RCTS to confirm that the intraoperative application of sivelestat sodium can effectively treat preoperative acute lung injury, improve CPB-related lung injury, and reduce the incidence of postoperative acute lung injury. Therefore, the objective of this study was to design A randomized controlled study to evaluate the clinical efficacy and safety of intraoperative use of sivelestat sodium to shorten the duration of postoperative invasive mechanical ventilation in acute type A aortic dissection patients with preoperative moderate to severe hypoxemia. The purpose of this preliminary clinical trial is to provide theoretical basis for sample size calculation of randomized controlled trials, and to evaluate the scientific nature and feasibility of randomized controlled trials.

Conditions

• Acute Aortic Dissection

Interventions

Type	Name	Description
DRUG	Sivelestat sodium was given intravenously	Anesthesia induction began with a 0.2mg/Kg/h pump test drug until 48 hours after endotracheal intubation was removed or up to 7 days. If the patient was judged to have successfully removed the endotracheal tube, drug administration was discontinued; If the endotracheal intubation was not removed successfully up to 7 days, drug administration was also discontinued. During CPB, 0.1mg/100mL of the experimental drug was injected into the circulating pump immediately after CPB began.
DRUG	Placebo was given intravenously	Anesthesia induction began with a 0.2mg/Kg/h pump test drug until 48 hours after endotracheal intubation was removed or up to 7 days. If the patient was judged to have successfully removed the endotracheal tube, drug administration was discontinued; If the endotracheal intubation was not removed successfully up to 7 days, drug administration was also discontinued. During CPB, 0.1mg/100mL of the experimental drug was injected into the circulating pump immediately after CPB began.

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-12-01
• Completion: 2024-02-01
• First posted: 2023-05-25
• Last updated: 2023-05-25

Locations

1 site across 1 country: China