Improvement of Pulmonary Insufficiency After Aortic Dissection With Sivelestat Sodium (IPIADSS)

April 22, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University

A Randomized Controlled Study of Sivelestat Sodium in Improving Pulmonary Insufficiency After Aortic Dissection Arch Surgery Under Hypothermic Circulatory Arrest

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a single-center, randomized, open-label, blank-controlled study, and designs to recruit AD perioperative patients admitted to the Cardiovascular Surgery Department of the First Affiliated Hospital of Xi'an Jiaotong University, between January 1, 2022 and December 31, 2022, with a total of 168 cases. After the patients who met the inclusion and exclusion criteria signed the informed consent, they were randomly assigned to the experimental group and the control group at a 1:1 ratio, with 84 cases in each group. The experimental group is additionally given sivelestat sodium in the perioperative period on the basis of the original treatment. The study was divided into two phases, the screening phase and the treatment phase. The screening period was from admission to the day of surgery to determine whether patients were suitable for the study. The treatment period is from the induction of anesthesia to the day of being transferred out from the ICU. It is necessary to complete the detailed treatment plan, and drug dosage, intraoperative and postoperative serological examinations, imaging examinations, and the patient's mechanical ventilation and oxygenation index data. Sivelestat sodium was used during and after operation in the experimental group, and the end time of administration was 96 hours after admission to the ICU. During the treatment with sivelestat sodium, the patient's original treatment plan will not be terminated or affected. The control group only received the original clinical diagnosis and treatment and clinical management. Study endpoints were defined as the day of ICU transfer, follow-up until discharge, or discontinuation/termination during the study period, or patient withdrawal from the study for any reason. During the study period, doctors will provide supportive treatment according to clinical indications, medication instructions and specifications. In the event of an adverse event, the doctor may make adjustments to the medication dose and treatment duration. The main observation indicators were the incidence of moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg) at 24, 72, and 120 hours after surgery, on the day of transfer out of ICU, and discharge. The efficacy and safety of the drug were evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xian Jiaotong University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Patients who are judged by the researchers to be unsuitable for inclusion, such as those with mental illnesses.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: sivelestat sodium on the basis of the original treatment
In the perioperative period, sivelestat sodium was added, and on the basis of not terminating and changing the original treatment plans.
Drug: Sivelestat sodium
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.
No Intervention: the original treatment
Only accept the original clinical diagnosis and treatment and clinical management.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of respiratory insufficiency
Time Frame: 24 hours after surgery
Incidence of postoperative moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg).
24 hours after surgery
Incidence of respiratory insufficiency
Time Frame: 72 hours after surgery
Incidence of postoperative moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg).
72 hours after surgery
Incidence of respiratory insufficiency
Time Frame: 120 hours after surgery
Incidence of postoperative moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg).
120 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of prolonged mechanical ventilation
Time Frame: 120 hours after surgery
Mechanical ventilation time > 72h
120 hours after surgery
Levels of neutrophil elastase activity
Time Frame: 24 hours after surgery
Preoperative and postoperative blood neutrophil elastase activity levels.
24 hours after surgery
Levels of neutrophil elastase activity
Time Frame: 72 hours after surgery
Preoperative and postoperative blood neutrophil elastase activity levels.
72 hours after surgery
Levels of neutrophil elastase activity
Time Frame: Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
Preoperative and postoperative blood neutrophil elastase activity levels.
Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
White blood cell count
Time Frame: 24 hours after surgery
Blood routine examination WBC count
24 hours after surgery
White blood cell count
Time Frame: Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
Blood routine examination WBC count
Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
plasma C-reactive protein
Time Frame: 24 hours after surgery
serial plasma high-sensitivity CRP
24 hours after surgery
plasma C-reactive protein
Time Frame: Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
serial plasma high-sensitivity CRP
Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
serum procalcitonin
Time Frame: 24 hours after surgery
Serum PCT level
24 hours after surgery
serum procalcitonin
Time Frame: Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
Serum PCT level
Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
serum interleukin-6
Time Frame: 24 hours after surgery
Serum IL-6 level
24 hours after surgery
serum interleukin-6
Time Frame: Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
Serum IL-6 level
Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tao Shi, PhD, First Affiliated Hospital of Xian Jiaotong University

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJTU1AF2021CRF-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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