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

May 23, 2023 updated by: Xiaotong Hou

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xiaomeng Wang, MD
  • Phone Number: 8610 64456631
  • Email: dxqzwxm@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sivelestat sodium group
sivelestat sodium
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.
Other Names:
  • Sivelestat sodium group
Placebo Comparator: Placebo control group
Placebo control
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.
Other Names:
  • Placebo control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive mechanical ventilation time
Time Frame: 28 days after surgery
Duration from the initiation of invasive mechanical ventilation to the first successful removal of the endotracheal tube
28 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaotong Hou

Investigators

  • Study Chair: Xiaomeng Wang, MD, Beijing Anzhen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

May 6, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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