Improvement of Pulmonary Insufficiency After Aortic Dissection With Sivelestat Sodium

NCT05343338 | Unknown

• 1 other identifier: XJTU1AF2021CRF-017
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Aortic dissection (AD) is one of the most dangerous cardiovascular emergencies, with rapid onset, rapid progression, high fatality rate, and a variety of life-threatening complications. Acute lung injury (ALI) caused by AD is an important cause of many adverse outcomes. Studies have confirmed that 34.9% to 53.8% of AAD patients have ALI before surgery, and Impaired preoperative lung function may lead to worse oxygenation after AD surgery. The pathophysiological mechanism of AD-induced ALI is complex. A variety of preoperative and intraoperative risk factors can induce or aggravate ALI, such as ischemia-reperfusion injury, deep hypothermic circulatory arrest, and inflammatory reactions. At present, the clinical use of improved surgery, cardiopulmonary bypass perfusion, early anti-inflammatory treatment, and protective lung ventilation can reduce and improve perioperative ALI to a certain extent, but it is still not ideal. In recent years, inhibition of neutrophil activation and aggregation, and reduction of neutrophil elastase activity as targets for the treatment of inflammatory injury have also become an important clinical treatment measure, in order to further reduce the body's inflammatory response to improve and alleviate ALI. Sivelestat sodium, as a neutrophil elastase inhibitor, is the only approved therapeutic drug for ALI/ acute respiratory distress syndrome (ARDS) in the world. It is precisely by reducing the inflammatory infiltration of neutrophils and inhibiting neutrophil elastase activity, thereby exerting a certain protective effect on the lungs. The study takes patients with AD surgery as the research object. On the basis of not terminating and changing the original treatment plans, sivelestat sodium was added in the perioperative period to observe the incidence, and severity of ALI/ARDS in the perioperative period. It aims to explore the efficacy and safety of sivelestat sodium in the treatment of pulmonary insufficiency after AD arch surgery under hypothermic circulatory arrest.

Conditions

Aortic Dissection; Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (3)

• Incidence of respiratory insufficiency

  Incidence of postoperative moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg).

  24 hours after surgery

• Incidence of respiratory insufficiency

  Incidence of postoperative moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg).

  72 hours after surgery

• Incidence of respiratory insufficiency

  Incidence of postoperative moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg).

  120 hours after surgery

Secondary Outcomes (12)

• Incidence of prolonged mechanical ventilation

  120 hours after surgery

• Levels of neutrophil elastase activity

  24 hours after surgery

• Levels of neutrophil elastase activity

  72 hours after surgery

• Levels of neutrophil elastase activity

  Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks

• White blood cell count

  24 hours after surgery

Study Arms (2)

sivelestat sodium on the basis of the original treatment

EXPERIMENTAL

In the perioperative period, sivelestat sodium was added, and on the basis of not terminating and changing the original treatment plans.

Drug: Sivelestat sodium

the original treatment

NO INTERVENTION

Only accept the original clinical diagnosis and treatment and clinical management.

Interventions

Sivelestat sodium DRUG

After dissolving sivelestat sodium with 0.9% sodium chloride injection, dilute the 1-day dose (4.8 mg/kg) with 50 mL of 0.9% sodium chloride injection and continue intravenously at a rate of 0.2 mg/kg/h for administration. The start time of administration was after induction of anesthesia, and at the same time, the extracorporeal circulation circuit is prefilled with 100 mg. The end time is 48 hours after admission to the ICU.

sivelestat sodium on the basis of the original treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged from 18 to 70 years old;
• Patients undergoing aortic dissection arch surgery under hypothermic circulatory arrest;
• Weight from 45 to 90kg;
• ASA cardiac function class from II to IV;
• Patients who can understand and comply with the requirements of the protocol and volunteer to participate.

You may not qualify if:

• Patients participating in other clinical studies;
• Patients with serious lack of medical data;
• Women who are pregnant or may become pregnant or breastfeeding;
• Patients with severe lung diseases, such as end-stage chronic obstructive pulmonary disease, chronic interstitial lung disease, etc.;
• Patients with malignant tumors;
• Preoperative oxygenation index PaO2/FiO2≤200mmHg;
• Patients with EUROScoreII mortality risk \< 3%;
• Patients with APACHE II score ≥ 21;

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Aortic Dissection; Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Tao Shi, PhD

  First Affiliated Hospital of Xian Jiaotong University

  STUDY CHAIR

Central Study Contacts

Tao Shi, PhD

CONTACT

0086-029-85323601; shi2009tao@163.com

Tao Ma, PhD

CONTACT

0086-029-85323866; mataodr@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 25, 2022
• Study Start: April 20, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

CN (1)