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

Not Applicable

Not yet recruiting

• Conditions: Acute Aortic Dissection
• Interventions: Drug: Placebo was given intravenously; Drug: Sivelestat sodium was given intravenously

• Registration Number: NCT05874700
• Lead Sponsor: Xiaotong Hou

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.

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05
• Study First Submitted: 2023-05-06
• Study First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Study First Posted: 2023-05-25
• Last Update Posted: 2023-05-25
• Primary Completion: 2023-12
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

1. Preoperative cardiogenic shock;
2. preoperative liver insufficiency;
3. Preoperative dissection involves important organs and seriously endangers the patient's life
4. Pregnant women;
5. hereditary connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome, etc.;
6. Behcet's disease;
7. aortitis;
8. There is a history of neurologic disease that has been clearly diagnosed;
9. There is a history of a clearly diagnosed mental illness;
10. There is a definite diagnosis of chronic respiratory disease;
11. There is a clearly diagnosed immune disease;
12. There is a definite diagnosis of hematological diseases;
13. severe renal failure or require dialysis treatment;
14. Taking anti-inflammatory or anti-coagulant drugs within a week before admission;
15. People who are allergic to sivelestat sodium and other ingredients;
16. Has participated in other clinical trials;
17. The clinician judges that it is not suitable for inclusion in the study;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo control group	Placebo was given intravenously	Placebo control
Sivelestat sodium group	Sivelestat sodium was given intravenously	sivelestat sodium

Primary Outcome Measures

Name	Time	Method
Invasive mechanical ventilation time	28 days after surgery	Duration from the initiation of invasive mechanical ventilation to the first successful removal of the endotracheal tube

Secondary Outcome Measures

Name	Time	Method
Total invasive mechanical ventilation	28 days after surgery	mode and duration
Total non-invasive mechanical ventilation	28 days after surgery	mode and duration
Total high flow oxygen uptake	28 days after surgery	mode and duration
Oxygenation index and area under curve	28 days after surgery	Oxygenation index
PaO2/FiO2≤300mmHg Duration	28 days after surgery	Duration of hypoxemia

Trial Locations

Locations (1)

Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China