ARDS Due to Disease Caused by SARS Co-V-2
Conditions
Brief summary
The goal of this retrospective multicentre cohort study is to examine the association between receipt of sivelestat and improvement in oxygenation among patients with acute respiratory distress syndrome (ARDS) induced by COVID-19. We used propensity score matching to compare the outcomes of patients treated with sivelestat to those who were not. The primary outcome was the PaO2/FiO2 ratio on Day 3. Secondary outcomes included 28-day mortality, alive and ICU-free days within 28 days, non-mechanical ventilation time within 28 days, the lengths of stay in the ICU and hospital, proportion of patients requiring extracorporeal membrane oxygenation (ECMO), proportion of patients undergoing endotracheal intubation or tracheotomy, and incidence of adverse events (AEs) or severe adverse events (SAEs).
Detailed description
We conducted a retrospective cohort study of patients admitted between December 2022 and May 2023 to general ICUs, respiratory ICUs and emergency ICUs across 14 hospitals in Jilin Province, China. We used propensity score matching to compare the outcomes of patients treated with sivelestat to those who were not. Sivelestat sodium was administered through a 24-hour continuous intravenous infusion at a rate of 0.2 mg/kg/h, for a maximum duration of 14 days.The primary outcome was the PaO2/FiO2 ratio on Day 3. Secondary outcomes included 28-day mortality, alive and ICU-free days within 28 days, non-mechanical ventilation time within 28 days, the lengths of stay in the ICU and hospital, proportion of patients requiring extracorporeal membrane oxygenation (ECMO), proportion of patients undergoing endotracheal intubation or tracheotomy, and incidence of adverse events (AEs) or severe adverse events (SAEs).
Interventions
Sivelestat sodium was administered through a 24-hour continuous intravenous infusion at a rate of 0.2 mg/kg/h, for at least 72 hours and a maximum duration of 14 days.
DRUGControl
Not use Sivelestat sodium
Sponsors
The First Hospital of Jilin University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\) equal to or more than 18 years old, 2) had positive COVID-19 reverse transcriptase-polymerase chain reaction test results from upper airway swab, 3) fulfilled the Berlin definition of ARDS
Exclusion criteria
pregnant or lactating women, those with concomitant severe chronic respiratory diseases or end-stage malignant tumours, patients with duration of hospital stay or sivelestat administration less than 72 hours and patients for whom complete outcome data were not available.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PaO2/FiO2 ratio on Day 3. | 3 days | PaO2/FiO2 ratio on Day 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | 28 days | 28-day mortality |
| non-mechanical ventilation time within 28 days | 28 days | non-mechanical ventilation time within 28 days |
Countries
China
Outcome results
None listed