Acute Respiratory Distress SyndromeNCT05672472
Neutrophil Elastase Inhibitor in Treatment of ARDS Patients With Mechanical Ventilation Caused by Sepsis
A study testing Sivelestat sodium in people with Acute Respiratory Distress Syndrome, run by The First Hospital of Jilin University.
Trial summary
Sepsis is a life-threatening organ dysfunction caused by the host's maladjusted response to infection. It is one of the common clinical critical diseases, often accompanied by multiple organ failure, immune imbalance and high mortality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Sivelestat sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2023to 10 Feb 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adults (aged 18-75)
- 2. Patients with ARDS caused by sepsis
- 3. Patients admitted to ICU and mechanically ventilated
- 4. Patients who can provide informed consent
Who cannot join
- 1. Pregnant or lactating women;
- 2. Patients allergic to planned medication;
- 3. Patients who are expected to stay in the ICU for less than 5 days;
- 4. Patients included in other trial items;
- 5. Other reasons that the researcher thinks are not suitable to participate in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study of Neutrophil Elastase Inhibitor in Treatment of Acute Respiratory Distress Syndrome Patients With Mechanical Ventilation Caused by Sepsis
Sepsis is a life-threatening organ dysfunction caused by the host's maladjusted response to infection. It is one of the common clinical critical diseases, often accompanied by multiple organ failure, immune imbalance and high mortality. Sepsis is a syndrome of physiological, pathological and biochemical abnormalities caused by infection. Its incidence rate and prevalence have been on the rise in the past few years. Sepsis has greatly endangered the lives and health of the public. Among them, ARDS is a fatal complication of sepsis and a common critical illness syndrome in ICU. At present, the conventional treatment for ARDS caused by sepsis is still limited to indirect supportive therapy such as primary disease treatment, infection control, mechanical ventilation support, and nutrition improvement, lacking specific direct treatment methods. So far, the drug treatment effect of ARDS at home and abroad is not satisfactory. Therefore, it has become an urgent task to find a new treatment strategy to alleviate ARDS. Neutrophil elastase inhibitors can reversibly and competitively inhibit the release of neutrophil elastase, inhibit the activation of neutrophils and the infiltration of inflammatory cells in the lungs, alleviate the release of inflammatory mediators, and thus improve respiratory function, which has a good protective effect on various experimental ARDS. However, the efficacy of neutrophil elastase inhibitor represented by sivelestat sodium in the treatment of ARDS has reached a relatively consistent positive conclusion in animal experiments, while the results of clinical studies are different. These differences in clinical research still need further analysis, research and verification in clinical trials.
At present, the clinical studies of neutrophil elastase inhibitors in the treatment of sepsis induced ARDS are very few, and there is a lack of related prospective randomized controlled clinical studies. Therefore, further prospective clinical trials are needed to evaluate the therapeutic effect of neutrophil elastase inhibitors on sepsis induced ARDS patients. This study is intended to determine whether neutrophil elastase inhibitor can reduce the mechanical ventilation time, Murray lung injury score, ICU hospitalization time and 28-day mortality of septic ARDS patients compared with the control group through a single center randomized controlled trial, so as to provide a new basis for the treatment strategy of septic ARDS patients.
Read the detailed description
Research content:
Randomized ARDS patients with mechanical ventilation caused by sepsis in the ICU were divided into test group (sivelestat sodium group) and control group (saline control group) according to 1:1 ratio. The mechanical ventilation time, lung injury score, ICU hospitalization time and 28-day mortality of the two groups were compared. Through statistical analysis, it was determined whether sivelestat sodium could reduce the mechanical ventilation time, lung injury score, ICU hospitalization time and 28-day mortality of ARDS patients caused by sepsis compared with the control group.
Research method and design scheme:
- Study Design: Single center, randomized, blind, parallel controlled study.
- Study population:
The patients with ARDS mechanical ventilation caused by sepsis admitted to the ICU of the First Hospital of Jilin University, aged 18-75 years, who can provide informed consent. According to sepsis 3.0, sepsis is a life-threatening organ dysfunction caused by the uncontrolled response of the body to infection. The diagnosis of ARDS is based on the Berlin definition.
(3) Intervention method:
- Simple random grouping method (excel) is used to randomly assign patients who meet the inclusion criteria by 1:1. The specific method is: open excel, enter patient number (1-100) in the first column, enter "=RANDBETWEEN (1,2)" in the first case of the second column, and pull down to complete the inclusion code of all patients. 1 is the test group and 2 is the control group. According to the previous research results, based on the time of mechanical ventilation (days), the sample size was calculated using the mean comparison formula of two groups of independent samples. The mean value of the test group was 6.6, the standard deviation of the test group was 6.1, the mean value of the control group was 11.1, and the standard deviation of the control group was 8.4, α=0.05, β= 0.2. The sample size of the test group and the control group was calculated as 42 cases respectively. To prevent the sample from falling off, 100 cases were proposed to be included in the group, 50 cases in the test group (sivelestat sodium group) and 50 cases in the control group (saline control group).
- Blinding method: after the intervention measures were implemented, the subjects were blinded, and sivelestat sodium and 0.9% sodium chloride were pumped intravenously in a uniform opaque packaging container. (4) Administration method:
- The patients in the test group were given 0.2 mg/kg. h of sivelestat sodium (0.1 g/tube, Shanghai Huilun Jiangsu Pharmaceutical Co., Ltd.) (the daily dose was added to 250 ml of 0.9% sodium chloride) intravenously for 24 hours and 5 consecutive days.
- The patients in the control group were given 250 ml 0.9% sodium chloride (250ml/bag, Jilin Dubang Pharmaceutical Co., Ltd.) by intravenous pump for 24 hours and 5 consecutive days. (5) Collect and observe indicators:
The demographic data (gender, age, height, weight), complications, APACHE II score, SOFA score, PCT, leukocytes, platelets, liver function, Murray lung injury score (Table 2), PaO2/FiO2, renal function, coagulation routine, Interleukin-2/4/6/10, mean arterial pressure, duration of mechanical ventilation, ICU hospitalization and 28-day survival were recorded.
(6) End point indicators:
- Primary outcome: The duration of mechanical ventilation was compared between the two groups.
- Secondary outcomes: Murray lung injury score, ICU hospitalization time and 28- day mortality were compared between the two groups. (7) Statistical analysis:
SPSS 22.0 statistical software was used. The measurement data of normal distribution were expressed as mean ± standard deviation (x ± s), and the measurement data of non-normal distribution were expressed as median (interquartile interval). The pairwise comparison between groups was performed by t test or Mann Whitney U test; The chi square test or Fisher exact probability method was used to compare the counting data; To compare whether there is statistical difference in the end point indicators between the test group and the control group. Kaplan Meier survival curve was used to analyze and compare the difference of 28- day mortality between the two groups. P<0.05 was considered as the difference with statistical significance.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Sivelestat sodium
- Keywords
- Acute respiratory distress syndrome, Sepsis, Neutrophil elastase inhibitor, Mechanical ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sivelestat sodiumDrug
Also called Mechanical ventilation
Continuous infusion of sivelestat sodium for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Sivelestat sodium | Experimental | The patients in the test group were given 0.2 mg/kg. h of sivelestat sodium (0.1 g/tube, Shanghai Huilun Jiangsu Pharmaceutical Co., Ltd.) (the daily dose was added to 250 ml of 0.9% sodium chloride) intravenously for 24 hours and 5 consecutive days. Receives: Drug: Sivelestat sodium |
| sodium chloride | Placebo comparator | The patients in the control group were given 250 ml 0.9% sodium chloride (250ml/bag, Jilin Dubang Pharmaceutical Co., Ltd.) by intravenous pump for 24 hours and 5 consecutive days. Receives: Drug: Sivelestat sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation time
Comparison of mechanical ventilation time between the two groups
Measured: 2 years
Secondary outcomes (2)
Murray Lung Injury Score
Comparison of Murray lung injury scores between the two groups
Measured: 2 years
ICU length of stay
Comparison of ICU length of stay between the two groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start10 Jan 2023 (estimated)
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Feb 2025 (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 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuting Li, The First Hospital of Jilin University
- Investigators
- Dong Zhang, doctor, Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672472
- Sponsor's protocol ID
- Yuting Li1
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not decided.
Publications
Miyoshi S, Hamada H, Ito R, Katayama H, Irifune K, Suwaki T, Nakanishi N, Kanematsu T, Dote K, Aibiki M, Okura T, Higaki J. Usefulness of a selective neutrophil elastase inhibitor, sivelestat, in acute lung injury patients with sepsis. Drug Des Devel Ther. 2013 Apr 10;7:305-16. doi: 10.2147/DDDT.S42004. Print 2013.
PubMed 23596346
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Neutrophil Elastase Inhibitor in Treatment of Acute Respiratory Distress Syndrome Patients With Mechanical Ventilation Caused by Sepsis
- ClinicalTrials.gov ID
- NCT05672472
- Acronym / sponsor ID
- Yuting Li1
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute respiratory distress syndrome, Sepsis, Neutrophil elastase inhibitor, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (estimated)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Feb 2025 (estimated)
- First posted
- 5 Jan 2023 (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.
Sepsis is a life-threatening organ dysfunction caused by the host's maladjusted response to infection. It is one of the common clinical critical diseases, often accompanied by multiple organ failure, immune imbalance and high mortality. Sepsis is a syndrome of physiological, pathological and biochemical abnormalities caused by infection. Its incidence rate and prevalence have been on the rise in the past few years. Sepsis has greatly endangered the lives and health of the public. Among them, ARDS is a fatal complication of sepsis and a common critical illness syndrome in ICU. At present, the conventional treatment for ARDS caused by sepsis is still limited to indirect supportive therapy such as primary disease treatment, infection control, mechanical ventilation support, and nutrition improvement, lacking specific direct treatment methods. So far, the drug treatment effect of ARDS at home and abroad is not satisfactory. Therefore, it has become an urgent task to find a new treatment strategy to alleviate ARDS. Neutrophil elastase inhibitors can reversibly and competitively inhibit the release of neutrophil elastase, inhibit the activation of neutrophils and the infiltration of inflammatory cells in the lungs, alleviate the release of inflammatory mediators, and thus improve respiratory function, which has a good protective effect on various experimental ARDS. However, the efficacy of neutrophil elastase inhibitor represented by sivelestat sodium in the treatment of ARDS has reached a relatively consistent positive conclusion in animal experiments, while the results of clinical studies are different. These differences in clinical research still need further analysis, research and verification in clinical trials.
At present, the clinical studies of neutrophil elastase inhibitors in the treatment of sepsis induced ARDS are very few, and there is a lack of related prospective randomized controlled clinical studies. Therefore, further prospective clinical trials are needed to evaluate the therapeutic effect of neutrophil elastase inhibitors on sepsis induced ARDS patients. This study is intended to determine whether neutrophil elastase inhibitor can reduce the mechanical ventilation time, Murray lung injury score, ICU hospitalization time and 28-day mortality of septic ARDS patients compared with the control group through a single center randomized controlled trial, so as to provide a new basis for the treatment strategy of septic ARDS patients.
Detailed description
Research content:
Randomized ARDS patients with mechanical ventilation caused by sepsis in the ICU were divided into test group (sivelestat sodium group) and control group (saline control group) according to 1:1 ratio. The mechanical ventilation time, lung injury score, ICU hospitalization time and 28-day mortality of the two groups were compared. Through statistical analysis, it was determined whether sivelestat sodium could reduce the mechanical ventilation time, lung injury score, ICU hospitalization time and 28-day mortality of ARDS patients caused by sepsis compared with the control group.
Research method and design scheme:
- Study Design: Single center, randomized, blind, parallel controlled study.
- Study population:
The patients with ARDS mechanical ventilation caused by sepsis admitted to the ICU of the First Hospital of Jilin University, aged 18-75 years, who can provide informed consent. According to sepsis 3.0, sepsis is a life-threatening organ dysfunction caused by the uncontrolled response of the body to infection. The diagnosis of ARDS is based on the Berlin definition.
(3) Intervention method:
- Simple random grouping method (excel) is used to randomly assign patients who meet the inclusion criteria by 1:1. The specific method is: open excel, enter patient number (1-100) in the first column, enter "=RANDBETWEEN (1,2)" in the first case of the second column, and pull down to complete the inclusion code of all patients. 1 is the test group and 2 is the control group. According to the previous research results, based on the time of mechanical ventilation (days), the sample size was calculated using the mean comparison formula of two groups of independent samples. The mean value of the test group was 6.6, the standard deviation of the test group was 6.1, the mean value of the control group was 11.1, and the standard deviation of the control group was 8.4, α=0.05, β= 0.2. The sample size of the test group and the control group was calculated as 42 cases respectively. To prevent the sample from falling off, 100 cases were proposed to be included in the group, 50 cases in the test group (sivelestat sodium group) and 50 cases in the control group (saline control group).
- Blinding method: after the intervention measures were implemented, the subjects were blinded, and sivelestat sodium and 0.9% sodium chloride were pumped intravenously in a uniform opaque packaging container. (4) Administration method:
- The patients in the test group were given 0.2 mg/kg. h of sivelestat sodium (0.1 g/tube, Shanghai Huilun Jiangsu Pharmaceutical Co., Ltd.) (the daily dose was added to 250 ml of 0.9% sodium chloride) intravenously for 24 hours and 5 consecutive days.
- The patients in the control group were given 250 ml 0.9% sodium chloride (250ml/bag, Jilin Dubang Pharmaceutical Co., Ltd.) by intravenous pump for 24 hours and 5 consecutive days. (5) Collect and observe indicators:
The demographic data (gender, age, height, weight), complications, APACHE II score, SOFA score, PCT, leukocytes, platelets, liver function, Murray lung injury score (Table 2), PaO2/FiO2, renal function, coagulation routine, Interleukin-2/4/6/10, mean arterial pressure, duration of mechanical ventilation, ICU hospitalization and 28-day survival were recorded.
(6) End point indicators:
- Primary outcome: The duration of mechanical ventilation was compared between the two groups.
- Secondary outcomes: Murray lung injury score, ICU hospitalization time and 28- day mortality were compared between the two groups. (7) Statistical analysis:
SPSS 22.0 statistical software was used. The measurement data of normal distribution were expressed as mean ± standard deviation (x ± s), and the measurement data of non-normal distribution were expressed as median (interquartile interval). The pairwise comparison between groups was performed by t test or Mann Whitney U test; The chi square test or Fisher exact probability method was used to compare the counting data; To compare whether there is statistical difference in the end point indicators between the test group and the control group. Kaplan Meier survival curve was used to analyze and compare the difference of 28- day mortality between the two groups. P<0.05 was considered as the difference with statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sivelestat sodium | Experimental | Drug: Sivelestat sodiumThe patients in the test group were given 0.2 mg/kg. h of sivelestat sodium (0.1 g/tube, Shanghai Huilun Jiangsu Pharmaceutical Co., Ltd.) (the daily dose was added to 250 ml of 0.9% sodium chloride) intravenously for 24 hours and 5 consecutive days. |
| sodium chloride | Placebo comparator | Drug: Sivelestat sodiumThe patients in the control group were given 250 ml 0.9% sodium chloride (250ml/bag, Jilin Dubang Pharmaceutical Co., Ltd.) by intravenous pump for 24 hours and 5 consecutive days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Adults (aged 18-75)
- 2. Patients with ARDS caused by sepsis
- 3. Patients admitted to ICU and mechanically ventilated
- 4. Patients who can provide informed consent
Key exclusion criteria (5 listed)
- 1. Pregnant or lactating women;
- 2. Patients allergic to planned medication;
- 3. Patients who are expected to stay in the ICU for less than 5 days;
- 4. Patients included in other trial items;
- 5. Other reasons that the researcher thinks are not suitable to participate in this study.
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 sodiumAlso: Mechanical ventilationContinuous infusion of sivelestat sodium for 5 days | Drug | Sivelestat sodium, sodium chloride |
Primary outcome
Mechanical ventilation time
Time frame: 2 years
Comparison of mechanical ventilation time between the two groups
2 secondary outcomes
Murray Lung Injury Score
Time frame: 2 years
ICU length of stay
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Results publication: PubMed 23596346Miyoshi S, Hamada H, Ito R, Katayama H, Irifune K, Suwaki T, Nakanishi N, Kanematsu T, Dote K, Aibiki M, Okura T, Higaki J. Usefulness of a selective neutrophil elastase inhibitor, sivelestat, in acute lung injury patients with sepsis. Drug Des Devel Ther. 2013 Apr 10;7:305-16. doi: 10.2147/DDDT.S42004. Print 2013.
- Usefulness of a selective neutrophil elastase inhibitor, sivelestat, in acute lung injury patients with sepsisLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not decided.
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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.
Dong Zhang, doctor study director
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
A study testing Sivelestat sodium in people with Acute Respiratory Distress Syndrome, run by The First Hospital of Jilin University.
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 4 inclusion and 5 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 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Yuting Li, master (13943179756, liyuting@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical ventilation time (time frame: 2 years). 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 NCT05672472, 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 Jan 2023.