ARDS
Conditions
Keywords
Sepsis, Respiratory Failure, ARDS, efficacy, Sivelestat sodium
Brief 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.
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.
Interventions
Sivelestat sodium 0.2mg/kg.h for 1-7 days
DRUGPlacebo
The same amount of NS containing only sivelestat sodium excipients
Sponsors
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression to ARDS within 7 days (Berlin criteria) | From study drug administration to days 7 | The proportion of patients with sepsis progressing to ARDS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | From administration to discharge hospital, up to 90 days | The number of days the subject stayed in the hospital |
| Oxygenation index (PaO2/FiO2) or SpO2 / FiO2 on day 1, 3 and 7 from drug administration | From study drug administration to days 7 | PaO2/FiO2 or SpO2 / FiO2 was recorded on day 1, 3 and 7 from drug administration |
| Concentration of inflammatory factors on day 1, 3 and 7 from drug administration | From study drug administration to days 7 | Inflammatory factors include Interleukin(IL)-1β,IL-6, IL-8, IL-10, tumor necrosis factor(TNF)-α |
| Concentration of neutrophil elastase on day 1, 3 and 7 from drug administration | From study drug administration to days 7 | Concentration of neutrophil elastase was recorded on day 1, 3 and 7 from drug administration |
| Platelet count on day 1, 3 and 7 from drug administration | From study drug administration to days 7 | Platelet count was recorded on day 1, 3 and 7 from drug administration |
| The 28-day mortality | From study drug administration to day 28 | Death of any cause from study drug administration to day 28 |
| Sequential organ failure assessment (SOFA) score on day 1, 3 and 7 from drug administration | From study drug administration to days 7 | The SOFA scores on day 1, 3 and 7 were recorded |
| The 28-day ventilator-free days (VFD) | From study drug administration to day 28 | Days alive and free from mechanical ventilation from study drug administration to day 28 |
| The 28-day shock-free days | From study drug administration to day 28 | 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 |
| The 28-day time to clinical improvement | From study drug administration to day 28 | 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. |
| The 90-day mortality | From study drug administration to day 90 | Death of any cause from study drug administration to day 90 |
| Concentration of C-reactive protein on day 1, 3 and 7 from drug administration | From study drug administration to days 7 | Concentration of High sensitivity C-reactive protein was recorded on day 1, 3 and 7 from drug administration |
Countries
China
Contacts
Primary ContactLiu ling, MD
Backup ContactYang yi, MD
Outcome results
None listed