The goal of this clinical trial is to learn if YD0743 works to treat sepsis-associated acute respiratory distress syndrome (ARDS) in adult patients admitted to the Intensive Care Unit. It will also learn about the safety of drug YD0743. The main questions it aims to answer are: Does YD0743 injection shorten the ventilator-using days in sepsis-associated ARDS patients? What medical problems do participants have when accepting YD0743 treatment? Researchers will compare YD0743 to a placebo (a look-alike substance that contains no active drug) to see if YD0743 works to treat sepsis-associated ARDS. Participants will: Accepting YD0743 injection at least for 7 days. Visit the clinic in person at the Day 28 to receive the follow-up check (D1 is defined as the first day starting the YD0743 or placebo treatment) .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
309
Administered as a 24-hour continuous infusion via micro-infusion pump.
Administered as a 24-hour continuous infusion via micro-infusion pump.
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, China
RECRUITINGNumber of Ventilator-Free Days
Number of Ventilator-Free Days within 28 Days
Time frame: Within 28 days after initiation of treatment
Change from Baseline and Change Rate in Oxygenation Index (PaO₂/FiO₂ Ratio)
Time frame: At Day 3, Day 5, Day 8, Day 15 post first dose, or within 24 hours after the end of treatment
Change from Baseline in Driving Pressure and Static Lung Compliance in participants receiving invasive mechanical ventilation
Formulas for Driving Pressure and Static Lung Compliance: Driving Pressure (ΔP) = Plateau Pressure(Pplat) - Positive End-Expiratory Pressure (PEEP) Static Lung Compliance = Tidal Volume/(Pplat - PEEP)
Time frame: At Day 3, Day 5, Day 8, Day 15 post first dose, or within 24 hours after end of treatment
Mortality Rate
ICU Mortality Rate, In-Hospital Mortality Rate, 28-Day All-Cause Mortality Rate, and Survival Time of participants who died within 28 days
Time frame: Within 28 days after initiation of treatment
Number of ICU Days and Total Hospital Days
Time frame: Within 28 days after initiation of treatment
Change from Baseline in Sequential Organ Failure Assessment (SOFA) Score
The SOFA score is a scale ranging from 0 to 24 points, with higher scores indicating worse organ function/a worse outcome.
Time frame: At Day 3, Day 5, Day 8, Day 15, Day 28 post first dose, or within 24 hours after end of treatment;
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Within 28 days after initiation of treatment
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