Aortic DissectionIPIADSSNCT05343338
Improvement of Pulmonary Insufficiency After Aortic Dissection With Sivelestat Sodium
A study testing Sivelestat sodium in people with Aortic Dissection and Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aortic Dissection, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Sivelestat sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Tao Shi, PhD, 0086-029-85323601, shi2009tao@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Sivelestat sodium
- Medical subject headings
- Aortic Dissection, Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sivelestat sodiumDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sivelestat sodium |
| the original treatment | No intervention | Only accept the original clinical diagnosis and treatment and clinical management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory insufficiency
Incidence of postoperative moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg).
Measured: 24 hours after surgery
Incidence of respiratory insufficiency
Incidence of postoperative moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg).
Measured: 72 hours after surgery
Incidence of respiratory insufficiency
Incidence of postoperative moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg).
Measured: 120 hours after surgery
Secondary outcomes (12)
Incidence of prolonged mechanical ventilation
Mechanical ventilation time > 72h
Measured: 120 hours after surgery
Levels of neutrophil elastase activity
Preoperative and postoperative blood neutrophil elastase activity levels.
Measured: 24 hours after surgery
Levels of neutrophil elastase activity
Preoperative and postoperative blood neutrophil elastase activity levels.
Measured: 72 hours after surgery
Levels of neutrophil elastase activity
Preoperative and postoperative blood neutrophil elastase activity levels.
Measured: Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
White blood cell count
Blood routine examination WBC count
Measured: 24 hours after surgery
White blood cell count
Blood routine examination WBC count
Measured: Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
plasma C-reactive protein
serial plasma high-sensitivity CRP
Measured: 24 hours after surgery
plasma C-reactive protein
serial plasma high-sensitivity CRP
Measured: Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
serum procalcitonin
Serum PCT level
Measured: 24 hours after surgery
serum procalcitonin
Serum PCT level
Measured: Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
serum interleukin-6
Serum IL-6 level
Measured: 24 hours after surgery
serum interleukin-6
Serum IL-6 level
Measured: Date of discharge from Cardiovascular Surgery ICU for any reason, or assessed up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start20 Apr 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Shi, PhD, Study chair, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343338
- Sponsor's protocol ID
- XJTU1AF2021CRF-017
- Acronym
- IPIADSS
- Status last verified
- Apr 2022
- First submitted
- 10 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Sivelestat Sodium in Improving Pulmonary Insufficiency After Aortic Dissection Arch Surgery Under Hypothermic Circulatory Arrest
- ClinicalTrials.gov ID
- NCT05343338
- Acronym / sponsor ID
- IPIADSS / XJTU1AF2021CRF-017
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sivelestat sodium on the basis of the original treatment | Experimental | Drug: Sivelestat sodiumIn the perioperative period, sivelestat sodium was added, and on the basis of not terminating and changing the original treatment plans. |
| the original treatment | No intervention | –Only accept the original clinical diagnosis and treatment and clinical management. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sivelestat sodiumAfter 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. | Drug | sivelestat sodium on the basis of the original treatment |
Primary outcome
Incidence of respiratory insufficiency
Time frame: 24 hours after surgery
Incidence of postoperative moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg).
Incidence of respiratory insufficiency
Time frame: 72 hours after surgery
Incidence of postoperative moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg).
Incidence of respiratory insufficiency
Time frame: 120 hours after surgery
Incidence of postoperative moderate to severe respiratory insufficiency (PaO2/FiO2 ≤ 200mmHg).
12 secondary outcomes
Incidence of prolonged mechanical ventilation
Time frame: 120 hours after surgery
Levels of neutrophil elastase activity
Time frame: 24 hours after surgery
Levels of neutrophil elastase activity
Time frame: 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
White blood cell count
Time frame: 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
plasma C-reactive protein
Time frame: 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
serum procalcitonin
Time frame: 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 interleukin-6
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Shi, PhD study chair
First Affiliated Hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sivelestat sodium in people with Aortic Dissection and Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Shi, PhD (0086-029-85323601, shi2009tao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory insufficiency (time frame: 24 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.