Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sivelestat sodium | Experimental | Sivelestat sodium 0.2mg/kg.h |
|
| placebo | Active Comparator | The same amount of NS containing only sivelestat sodium excipients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sivelestat sodium | Drug | Sivelestat sodium 0.2mg/kg.h for 1-7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression to ARDS within 7 days (Berlin criteria) | The proportion of patients with sepsis progressing to ARDS | From study drug administration to days 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From study drug administration to days 7 |
| Concentration of inflammatory factors on day 1, 3 and 7 from drug administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu ling, MD | Contact | +86-25-83262552 | liulingdoctor@126.com | |
| Yang yi, MD | Contact | +86-25-83262552 | yiyiyang2004@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liu ling, MD | Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Zhong-Da Hospital, Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37709320 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
The same amount of NS containing only sivelestat sodium excipients |
|
Inflammatory factors include Interleukin(IL)-1β,IL-6, IL-8, IL-10, tumor necrosis factor(TNF)-α |
| 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 | 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 | 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 | 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 | 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 | 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 | 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. | From study drug administration to day 28 |
| Length of hospital stay | The number of days the subject stayed in the hospital | From administration to discharge hospital, up to 90 days |
| The 28-day mortality | Death of any cause from study drug administration to day 28 | From study drug administration to day 28 |
| The 90-day mortality | Death of any cause from study drug administration to day 90 | From study drug administration to day 90 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |