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

NCT05874700 | Unknown DMC

• 1 other identifier: 2023-4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Aortic Dissection

Keywords

acute type A aortic dissection; preoperative moderate to severe hypoxemia; sivelestat sodium

Outcome Measures

Primary Outcomes (1)

• Invasive mechanical ventilation time

  Duration from the initiation of invasive mechanical ventilation to the first successful removal of the endotracheal tube

  28 days after surgery

Secondary Outcomes (5)

• Total invasive mechanical ventilation

  28 days after surgery

• Total non-invasive mechanical ventilation

  28 days after surgery

• Total high flow oxygen uptake

  28 days after surgery

• Oxygenation index and area under curve

  28 days after surgery

• PaO2/FiO2≤300mmHg Duration

  28 days after surgery

Study Arms (2)

Sivelestat sodium group

EXPERIMENTAL

sivelestat sodium

Drug: Sivelestat sodium was given intravenously

Placebo control group

PLACEBO COMPARATOR

Placebo control

Drug: Placebo was given intravenously

Interventions

Sivelestat sodium was given intravenously DRUG

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.

Also known as: Sivelestat sodium group

Sivelestat sodium group

Placebo was given intravenously DRUG

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.

Also known as: Placebo control group

Placebo control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• aortitis;
• 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;
• There is a definite diagnosis of hematological diseases;
• severe renal failure or require dialysis treatment;
• Taking anti-inflammatory or anti-coagulant drugs within a week before admission;
• People who are allergic to sivelestat sodium and other ingredients;

Sponsors & Collaborators

• Xiaotong Hou: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (24)

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Study Officials

• Xiaomeng Wang, MD

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

Xiaotong Hou, MD

CONTACT

8610 64456631; xt.hou@ccmu.edu.cn

Xiaomeng Wang, MD

CONTACT

8610 64456631; dxqzwxm@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 25, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)