Acute Aortic Dissection
Conditions
Keywords
acute type A aortic dissection, preoperative moderate to severe hypoxemia, sivelestat sodium
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.
Interventions
DRUGSivelestat 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.
DRUGPlacebo 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.
Sponsors
Xiaotong Hou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactXiaotong Hou, MD
Backup ContactXiaomeng Wang, MD
Outcome results
None listed