Cardiac DiseasePhase 3NCT06276569
Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Lung Injury or Acute Respiratory Distress Syndrome After Cardiac Surgery
A Phase 3 study testing Sivelestat in people with Cardiac Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
The aim of this study is to assess the effectiveness and safety of sivelestat sodium in preventing acute lung injury and/or acute respiratory distress syndrome (ALI/ARDS) following cardiac surgery, with the objective of providing evidence-based support for its clinical application. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Sivelestat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 382 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2024to 30 Jul 2025
- Phase
- Phase 3
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 50 and 80 years old.
- Both sexes.
- Patients undergoing elective cardiac surgery;informed consent.
Who cannot join
- Patients undergoing emergency surgery.
- Patients undergoing deep hypothermic circulatory arrest surgery;.
- Patients with liver and kidney dysfunction (Child-Pugh class B or C, estimated glomerular filtration rate <35 mL/min/1.73 m2).
- Patients with abnormal baseline inflammatory markers [interleukin-6 (IL6) >10 pg/mL, procalcitonin (PCT) >0.5 ng/mL, C-reactive protein (CRP) >10 mg/L].
- Patients diagnosed with inflammatory immune disease, infectious disease, or oncological disease; patients receiving other medications that inhibit neutrophil elastase (e.g., ulinastatin, alpha 1-antiprotease).
- Patients allergic to or intolerant to sodium sivelestat.
- Pregnant.
- Patients with prognostic mortality on the European System for Cardiac Surgery Risk Evaluation II (EuroSCORE II) >3% were randomly assigned to either the treatment group or the control group based on the inclusion and exclusion criteria.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing
About this study
Official title: A Single-center, Randomized, Controlled, Study Evaluating the Efficacy and Safety of Sivelestat Sodium in Preventing Postoperative Acute Lung Injury or Acute Respiratory Distress Syndrome Following Cardiac Surgery
The aim of this study is to assess the effectiveness and safety of sivelestat sodium in preventing acute lung injury and/or acute respiratory distress syndrome (ALI/ARDS) following cardiac surgery, with the objective of providing evidence-based support for its clinical application.
Read the detailed description
This study is being performed as a randomized, placebo-controlled trial conducted in 442 patients who met the inclusion and exclusion criteria and were scheduled for elective cardiac surgery. Following informed consent, patients were randomly assigned to either the experimental group or the control group, with the study drug administered after transfer to the ICU post-surgery. In the experimental group, sivelestat was dissolved in 0.9% sodium chloride injection and diluted with 50ml of the same solution to achieve a dose of 4.8mg/kg/day; this mixture was then placed in a sealed package and administered intravenously at a rate of 0.2 mg/kg/h for seven consecutive days. The control group received an equivalent volume (50ml) of saline continuously administered intravenously at a rate of 0.2 mg/kg/hour. Demographic and clinical information, including admission diagnosis, underlying diseases, medical history, surgical history, details of the surgical procedure, postoperative complications, and in-hospital outcomes were collected from all participants. The primary outcome is the incidence of postoperative ARDS. Secondary outcome measures include data collection on the following parameters: elevated inflammatory response indices (WBC>20×109/L; IL-6>301.88mg/ml; CRP>49.76mg/L; PCT>2.18ng/ml) on postoperative days 1, 3, 5, and 7; APACHE II score; Murray lung injury score; incidence of severe pneumonia; mechanical ventilation-free rate at day 28; mortality rates at both day 28 and day 90. Adverse events such as liver injury, leukopenia, and thrombocytopenia resulting from sivelestat treatment were also monitored. Additionally,during the follow-up period, mortality within a 90-day period will be recorded.
- Conditions
- Cardiac Disease
- Being tested
- Sivelestat, placebo
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SivelestatDrug
(1)Experimental group: Received intravenous sivelestat sodium admission to the ICU. Sivelestat sodium was dissolved in 0.9% sodium chloride injection and a one-day dose (4.8mg/kg) was diluted in 50ml of 0.9% sodium chloride injection, which was then sealed for continuous intravenous administration at a rate of 0.2 mg/kg/h for seven consecutive days.
placeboOther
2)Control group: Receiving the same dose of placebo, 50 ml of saline, were administered intravenously at a rate of 0.2 mg/kg throughout the treatment period without any discernible impact on patient's regular treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| sivelestat group | Experimental | sivelestat was dissolved in 0.9% sodium chloride injection and diluted with 50ml of the same solution to achieve a dose of 4.8mg/kg/day; this mixture was then placed in a sealed package and administered intravenously at a rate of 0.2 mg/kg/h for seven consecutive days. Receives: Drug: Sivelestat |
| placebo comparator | Placebo comparator | received an equivalent volume (50ml) of saline continuously administered intravenously at a rate of 0.2 mg/kg/hour. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation index
SpO2 /FIO2
Measured: postoperative day 1, 3, 5 and 7
Inflammatory index
WBC[×109/L], Neutrophil[NEU,%], Interleukin(IL)-1β[pg/mL], IL-6[pg/mL], IL-8[pg/mL], TNF-α[pg/mL], CRP[mg/L], PCT[ng/mL], neutrophil elastase[NE,ng/mL] and myeloperoxidase[MPO, ng/ml]
Measured: postoperative day 1, 3, 5 and 7
Myocardial injury marker
myoglobin[Myo, ng/ml], CK-MB[ng/ml], hs-cTnI[ng/ml]
Measured: postoperative day 1, 3, 5 and 7
Acute physiology and chronic health evaluation(APACHE II) socre
Interpretation of APACHE II : minimum 0 and maximum 71; increasing score is associated with an increasing risk of hospital death. acute physiology score, chronic health status score, and age adjustment score
Measured: postoperative day 1, 3, 5 and 7
Murray socre
Interpretation of Murray socre : the Murray Lung Injury Score, a clinical assessment tool for evaluating the severity of acute lung injury. The score ranges from 0 to 4, with higher scores indicating worse pulmonary function and more severe lung injury.
Measured: postoperative day 1, 3, 5 and 7
ICU time
Time to stay in the intensive care unit
Measured: postoperative 28 days
In-hospital time
All time during hospitalization
Measured: postoperative 28 days
30-day all-cause mortality
Proportion of deaths caused by various reasons within a certain period of time (30 days) compared to the total number of people in a certain group
Measured: postoperative 30 dayS
90-day all-cause mortality
Proportion of deaths caused by various reasons within a certain period of time (90 days) compared to the total number of people in a certain group
Measured: postoperative 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start18 Feb 2024
- Primary completion30 Apr 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuo Pan, MD, Study director, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276569
- Sponsor's protocol ID
- 2023-LCYJ-MS-26
- Status last verified
- Apr 2025
- First submitted
- 31 Jan 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan T, Xu C, Wang YP, Wang HL, Su WX, Zhang HT, Zhu EJ, Li YT, Lv ZK, Zhu TT, Xu ZW, Gao Y, Xu CZ, Shi J, Ji WJ, Duan ZH, Zhang C, Xu ZJ, Li KS, Chong H, Zhu XY, Xue YX, Xu WZ, Chen C, Zhao WW, Ye JX, Ge M, Xu GJ, Wu SM, Pan J, Wang DJ, Qu JZ, Wang Q. Sivelestat and Incidence of Acute Respiratory Distress Syndrome After Cardiovascular Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e260390. doi: 10.1001/jamanetworkopen.2026.0390.
PubMed 41811317
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Controlled, Study Evaluating the Efficacy and Safety of Sivelestat Sodium in Preventing Postoperative Acute Lung Injury or Acute Respiratory Distress Syndrome Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06276569
- Acronym / sponsor ID
- 2023-LCYJ-MS-26
- Conditions
- Cardiac Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 26 Feb 2024 (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.
The aim of this study is to assess the effectiveness and safety of sivelestat sodium in preventing acute lung injury and/or acute respiratory distress syndrome (ALI/ARDS) following cardiac surgery, with the objective of providing evidence-based support for its clinical application.
Detailed description
This study is being performed as a randomized, placebo-controlled trial conducted in 442 patients who met the inclusion and exclusion criteria and were scheduled for elective cardiac surgery. Following informed consent, patients were randomly assigned to either the experimental group or the control group, with the study drug administered after transfer to the ICU post-surgery. In the experimental group, sivelestat was dissolved in 0.9% sodium chloride injection and diluted with 50ml of the same solution to achieve a dose of 4.8mg/kg/day; this mixture was then placed in a sealed package and administered intravenously at a rate of 0.2 mg/kg/h for seven consecutive days. The control group received an equivalent volume (50ml) of saline continuously administered intravenously at a rate of 0.2 mg/kg/hour. Demographic and clinical information, including admission diagnosis, underlying diseases, medical history, surgical history, details of the surgical procedure, postoperative complications, and in-hospital outcomes were collected from all participants. The primary outcome is the incidence of postoperative ARDS. Secondary outcome measures include data collection on the following parameters: elevated inflammatory response indices (WBC>20×109/L; IL-6>301.88mg/ml; CRP>49.76mg/L; PCT>2.18ng/ml) on postoperative days 1, 3, 5, and 7; APACHE II score; Murray lung injury score; incidence of severe pneumonia; mechanical ventilation-free rate at day 28; mortality rates at both day 28 and day 90. Adverse events such as liver injury, leukopenia, and thrombocytopenia resulting from sivelestat treatment were also monitored. Additionally,during the follow-up period, mortality within a 90-day period will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sivelestat group | Experimental | Drug: Sivelestatsivelestat was dissolved in 0.9% sodium chloride injection and diluted with 50ml of the same solution to achieve a dose of 4.8mg/kg/day; this mixture was then placed in a sealed package and administered intravenously at a rate of 0.2 mg/kg/h for seven consecutive days. |
| placebo comparator | Placebo comparator | Other: placeboreceived an equivalent volume (50ml) of saline continuously administered intravenously at a rate of 0.2 mg/kg/hour. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 50 and 80 years old.
- Both sexes.
- Patients undergoing elective cardiac surgery;informed consent.
Key exclusion criteria (8 listed)
- Patients undergoing emergency surgery.
- Patients undergoing deep hypothermic circulatory arrest surgery;.
- Patients with liver and kidney dysfunction (Child-Pugh class B or C, estimated glomerular filtration rate <35 mL/min/1.73 m2).
- Patients with abnormal baseline inflammatory markers [interleukin-6 (IL6) >10 pg/mL, procalcitonin (PCT) >0.5 ng/mL, C-reactive protein (CRP) >10 mg/L].
- Patients diagnosed with inflammatory immune disease, infectious disease, or oncological disease; patients receiving other medications that inhibit neutrophil elastase (e.g., ulinastatin, alpha 1-antiprotease).
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(1)Experimental group: Received intravenous sivelestat sodium admission to the ICU. Sivelestat sodium was dissolved in 0.9% sodium chloride injection and a one-day dose (4.8mg/kg) was diluted in 50ml of 0.9% sodium chloride injection, which was then sealed for continuous intravenous administration at a rate of 0.2 mg/kg/h for seven consecutive days. | Drug | sivelestat group |
| placebo2)Control group: Receiving the same dose of placebo, 50 ml of saline, were administered intravenously at a rate of 0.2 mg/kg throughout the treatment period without any discernible impact on patient's regular treatment regimen. | Other | placebo comparator |
Primary outcome
Oxygenation index
Time frame: postoperative day 1, 3, 5 and 7
SpO2 /FIO2
Inflammatory index
Time frame: postoperative day 1, 3, 5 and 7
WBC[×109/L], Neutrophil[NEU,%], Interleukin(IL)-1β[pg/mL], IL-6[pg/mL], IL-8[pg/mL], TNF-α[pg/mL], CRP[mg/L], PCT[ng/mL], neutrophil elastase[NE,ng/mL] and myeloperoxidase[MPO, ng/ml]
Myocardial injury marker
Time frame: postoperative day 1, 3, 5 and 7
myoglobin[Myo, ng/ml], CK-MB[ng/ml], hs-cTnI[ng/ml]
Acute physiology and chronic health evaluation(APACHE II) socre
Time frame: postoperative day 1, 3, 5 and 7
Interpretation of APACHE II : minimum 0 and maximum 71; increasing score is associated with an increasing risk of hospital death. acute physiology score, chronic health status score, and age adjustment score
Murray socre
Time frame: postoperative day 1, 3, 5 and 7
Interpretation of Murray socre : the Murray Lung Injury Score, a clinical assessment tool for evaluating the severity of acute lung injury. The score ranges from 0 to 4, with higher scores indicating worse pulmonary function and more severe lung injury.
ICU time
Time frame: postoperative 28 days
Time to stay in the intensive care unit
In-hospital time
Time frame: postoperative 28 days
All time during hospitalization
30-day all-cause mortality
Time frame: postoperative 30 dayS
Proportion of deaths caused by various reasons within a certain period of time (30 days) compared to the total number of people in a certain group
90-day all-cause mortality
Time frame: postoperative 90 days
Proportion of deaths caused by various reasons within a certain period of time (90 days) compared to the total number of people in a certain group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Derived from this study: PubMed 41811317Pan T, Xu C, Wang YP, Wang HL, Su WX, Zhang HT, Zhu EJ, Li YT, Lv ZK, Zhu TT, Xu ZW, Gao Y, Xu CZ, Shi J, Ji WJ, Duan ZH, Zhang C, Xu ZJ, Li KS, Chong H, Zhu XY, Xue YX, Xu WZ, Chen C, Zhao WW, Ye JX, Ge M, Xu GJ, Wu SM, Pan J, Wang DJ, Qu JZ, Wang Q. Sivelestat and Incidence of Acute Respiratory Distress Syndrome After Cardiovascular Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e260390. doi: 10.1001/jamanetworkopen.2026.0390.
- Individual participant dataSharing planned: No
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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.
Tuo Pan, MD study director
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sivelestat in people with Cardiac Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 6 Aug 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation index (time frame: postoperative day 1, 3, 5 and 7). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06276569, which also lists 1 linked publication.
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 6 Aug 2025.