ARDSPhase 3NCT04973670
Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis
A Phase 3 study testing Sivelestat sodium in people with ARDS, run by Southeast University, China at 1 site in China.
Trial summary
Sivelestat sodium has been approved for use in patients with SIRS and ALI, but whether it can protect patients with sepsis from developing ARDS remains unknown.The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ARDS
- What is being tested?
- Sivelestat sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2021to 30 Oct 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Within 24 hours after admission, sepsis 3.0 diagnostic criteria were met;
- The patients or their family members fully understand the purpose and significance of the trial, voluntarily participate in the clinical trial, and sign the informed consent.
Who cannot join
- Patients with ARDS were identified at the time of admission;
- Patients who explicitly refused mechanical ventilation;
- Patients with 3 or more extrapulmonary organ injuries and organ failure(single organ SOFA score ≥ 3);
- Patients who need home oxygen therapy or with home mechanical ventilation (by tracheotomy or noninvasive ventilation, but excluding CPAP / BiPAP, only for patients with obstructive sleep apnea);
- The patient whose expected survival time was less than 48 hours;
- Pregnant women and lactating women;
- Other conditions judged by the researcher not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Zhong-Da Hospital, Southeast University
Nanjing, Jiangsu, 210009
Ling Liu, pHd, +86-25-83262550, liulingdoctor@gmail.com
Yang Yi, pHd, +86-25-83262552, yiyiyang2004@gmail.com
About this study
Official title: Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis: Multicenter, Random, Double-blind, Parallel, Placebo Control Clinical Trials
Sivelestat sodium has been approved for use in patients with SIRS and ALI, but whether it can protect patients with sepsis from developing ARDS remains unknown.The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis.
Read the detailed description
The study was conducted in accordance with good clinical practice and with the guidelines set out in the Declaration of Helsinki. After approval from local and national ethics committees, patients from 3 centers in China were recruited.
All patients were randomized, in a double-blind manner, to receive either sivelestat sodium regimen or a placebo regimen for 1- 7 days in ICU.
The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis.
- Conditions
- ARDS
- Being tested
- Sivelestat sodium, Placebo
- Keywords
- Sepsis, Respiratory Failure, ARDS, efficacy, Sivelestat sodium
- Medical subject headings
- Sepsis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sivelestat sodiumDrug
Sivelestat sodium 0.2mg/kg.h for 1-7 days
PlaceboDrug
The same amount of NS containing only sivelestat sodium excipients
| Study group | Role | What they receive |
|---|---|---|
| Sivelestat sodium | Experimental | Sivelestat sodium 0.2mg/kg.h Receives: Drug: Sivelestat sodium |
| placebo | Active comparator | The same amount of NS containing only sivelestat sodium excipients Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression to ARDS within 7 days (Berlin criteria)
The proportion of patients with sepsis progressing to ARDS
Measured: From study drug administration to days 7
Secondary outcomes (12)
Oxygenation index (PaO2/FiO2) or SpO2 / FiO2 on day 1, 3 and 7 from drug administration
PaO2/FiO2 or SpO2 / FiO2 was recorded on day 1, 3 and 7 from drug administration
Measured: From study drug administration to days 7
Concentration of inflammatory factors on day 1, 3 and 7 from drug administration
Inflammatory factors include Interleukin(IL)-1β,IL-6, IL-8, IL-10, tumor necrosis factor(TNF)-α
Measured: From study drug administration to days 7
Concentration of neutrophil elastase on day 1, 3 and 7 from drug administration
Concentration of neutrophil elastase was recorded on day 1, 3 and 7 from drug administration
Measured: From study drug administration to days 7
Platelet count on day 1, 3 and 7 from drug administration
Platelet count was recorded on day 1, 3 and 7 from drug administration
Measured: From study drug administration to days 7
Concentration of C-reactive protein on day 1, 3 and 7 from drug administration
Concentration of High sensitivity C-reactive protein was recorded on day 1, 3 and 7 from drug administration
Measured: From study drug administration to days 7
Sequential organ failure assessment (SOFA) score on day 1, 3 and 7 from drug administration
The SOFA scores on day 1, 3 and 7 were recorded
Measured: From study drug administration to days 7
The 28-day ventilator-free days (VFD)
Days alive and free from mechanical ventilation from study drug administration to day 28
Measured: From study drug administration to day 28
The 28-day shock-free days
Days alive and free from vasopressor support which define as infusion of any vasopressor/inotrope agent for a minimum of 1 hour (i.e.norepinephrine, epinephrine, phenylephrine, vasopressin analogues, angiotensin, dopamine, dobutamine, milrinone or levosimendan) from study drug administration to day 28
Measured: From study drug administration to day 28
The 28-day time to clinical improvement
Defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first. The seven-category ordinal scale consisted of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7, death.
Measured: From study drug administration to day 28
Length of hospital stay
The number of days the subject stayed in the hospital
Measured: From administration to discharge hospital, up to 90 days
The 28-day mortality
Death of any cause from study drug administration to day 28
Measured: From study drug administration to day 28
The 90-day mortality
Death of any cause from study drug administration to day 90
Measured: From study drug administration to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start11 Oct 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
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 ARDSStudies of the same condition, open and under way.
- 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
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Liu ling, MD, Study chair, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973670
- Sponsor's protocol ID
- ZDHL
- Status last verified
- Apr 2023
- First submitted
- 13 Jul 2021
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma S, Li C, Gao Z, Xie J, Qiu H, Yang Y, Liu L. Effects of intravenous sivelestat sodium on prevention of acute respiratory distress syndrome in patients with sepsis: study protocol for a double-blind multicentre randomised controlled trial. BMJ Open. 2023 Sep 13;13(9):e074756. doi: 10.1136/bmjopen-2023-074756.
PubMed 37709320
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis: Multicenter, Random, Double-blind, Parallel, Placebo Control Clinical Trials
- ClinicalTrials.gov ID
- NCT04973670
- Acronym / sponsor ID
- ZDHL
- Conditions
- ARDS
- Keywords
- Sepsis, Respiratory Failure, ARDS, efficacy, Sivelestat sodium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 22 Jul 2021 (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.
Sivelestat sodium has been approved for use in patients with SIRS and ALI, but whether it can protect patients with sepsis from developing ARDS remains unknown.The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis.
Detailed description
The study was conducted in accordance with good clinical practice and with the guidelines set out in the Declaration of Helsinki. After approval from local and national ethics committees, patients from 3 centers in China were recruited.
All patients were randomized, in a double-blind manner, to receive either sivelestat sodium regimen or a placebo regimen for 1- 7 days in ICU.
The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis.
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 sodium | Experimental | Drug: Sivelestat sodiumSivelestat sodium 0.2mg/kg.h |
| placebo | Active comparator | Drug: PlaceboThe same amount of NS containing only sivelestat sodium excipients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Within 24 hours after admission, sepsis 3.0 diagnostic criteria were met;
- The patients or their family members fully understand the purpose and significance of the trial, voluntarily participate in the clinical trial, and sign the informed consent.
Key exclusion criteria (7 listed)
- Patients with ARDS were identified at the time of admission;
- Patients who explicitly refused mechanical ventilation;
- Patients with 3 or more extrapulmonary organ injuries and organ failure(single organ SOFA score ≥ 3);
- Patients who need home oxygen therapy or with home mechanical ventilation (by tracheotomy or noninvasive ventilation, but excluding CPAP / BiPAP, only for patients with obstructive sleep apnea);
- The patient whose expected survival time was less than 48 hours;
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 sodiumSivelestat sodium 0.2mg/kg.h for 1-7 days | Drug | Sivelestat sodium |
| PlaceboThe same amount of NS containing only sivelestat sodium excipients | Drug | placebo |
Primary outcome
Progression to ARDS within 7 days (Berlin criteria)
Time frame: From study drug administration to days 7
The proportion of patients with sepsis progressing to ARDS
12 secondary outcomes
Oxygenation index (PaO2/FiO2) or SpO2 / FiO2 on day 1, 3 and 7 from drug administration
Time frame: From study drug administration to days 7
Concentration of inflammatory factors on day 1, 3 and 7 from drug administration
Time frame: From study drug administration to days 7
Concentration of neutrophil elastase on day 1, 3 and 7 from drug administration
Time frame: From study drug administration to days 7
Platelet count on day 1, 3 and 7 from drug administration
Time frame: From study drug administration to days 7
Concentration of C-reactive protein on day 1, 3 and 7 from drug administration
Time frame: From study drug administration to days 7
Sequential organ failure assessment (SOFA) score on day 1, 3 and 7 from drug administration
Time frame: From study drug administration to days 7
The 28-day ventilator-free days (VFD)
Time frame: From study drug administration to day 28
The 28-day shock-free days
Time frame: From study drug administration to day 28
The 28-day time to clinical improvement
Time frame: From study drug administration to day 28
Length of hospital stay
Time frame: From administration to discharge hospital, up to 90 days
The 28-day mortality
Time frame: From study drug administration to day 28
The 90-day mortality
Time frame: From study drug administration to day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Derived from this study: PubMed 37709320Ma S, Li C, Gao Z, Xie J, Qiu H, Yang Y, Liu L. Effects of intravenous sivelestat sodium on prevention of acute respiratory distress syndrome in patients with sepsis: study protocol for a double-blind multicentre randomised controlled trial. BMJ Open. 2023 Sep 13;13(9):e074756. doi: 10.1136/bmjopen-2023-074756.
- 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.
Liu ling, MD study chair
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
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 sodium in people with ARDS, run by Southeast University, China 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 2 inclusion and 7 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 5 Apr 2023. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu ling, MD (+86-25-83262552, liulingdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression to ARDS within 7 days (Berlin criteria) (time frame: From study drug administration to days 7). 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 NCT04973670, 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 5 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.