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

Xiaotong Hou1 site in 1 country30 target enrollmentMay 2023

ConditionsAcute Aortic Dissection

InterventionsSivelestat sodium was given intravenously Placebo was given intravenously

DrugsSivelestat sodium was given intravenously Placebo was given intravenously

Overview

Phase: Not Applicable
Intervention: Sivelestat sodium was given intravenously
Conditions: Acute Aortic Dissection
Sponsor: Xiaotong Hou
Enrollment: 30
Locations: 1
Primary Endpoint: Invasive mechanical ventilation time
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2023

End Date

February 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xiaotong Hou

Responsible Party

Sponsor Investigator

Principal Investigator

Xiaotong Hou

Clinical Professor

Beijing Anzhen Hospital

Eligibility Criteria

Inclusion Criteria

•Aged 18-75;
•Spontaneous acute (≤14 days) type A aortic dissection;
•In the emergency department, hypothermic circulatory arrest combined with unilateral anterograde cerebral perfusion was expected to be performed on the aortic arch surgery;
•Preoperative PaO2/FiO2≤200mmHg;

Exclusion Criteria

•Preoperative cardiogenic shock;
•preoperative liver insufficiency;
•Preoperative dissection involves important organs and seriously endangers the patient's life
•Pregnant women;
•hereditary connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome, etc.;
•Behcet's disease;
•There is a history of neurologic disease that has been clearly diagnosed;
•There is a history of a clearly diagnosed mental illness;
•There is a definite diagnosis of chronic respiratory disease;
•There is a clearly diagnosed immune disease;