acute respiratory distress syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age >=18 years old; 2.Intubation ARDS in line with the A new global definition of acute respiratory distress syndromein 2023; 3.Patients requiring sedative therapy during ARDS treatment, with a sedation duration of>=72 hours (for patients receiving intermittent sedative therapy multiple times, the first treatment period with sedation duration >= 72 hours shall be considered); 4.Patients underwent standardized treatment during hospitalization (antibiotic selection, standardized ventilator setup, prone position ventilation implementation, etc.); 5.All medical institutions voluntarily participate in the study, can understand and abide by the requirements of the agreement, and voluntarily participate in the study, and patients or their families sign informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients who underwent general anesthesia 48 hours before diagnosis of ARDS, patients who used cardiopulmonary bypass or extracorporeal membrane oxygenation 48 hours before diagnosis and observation period; 2.Severe hepatic and renal insufficiency: severe, pre-existing substantial liver disease with clinically significant portal hypertension, Child-Pugh grade C cirrhosis/acute liver failure, or patients requiring artificial liver treatment; Patients with acute and chronic renal insufficiency who need renal replacement therapy; 3.Patients with severe and extremely severe craniocerebral injury, increased intracranial pressure, cerebrovascular accident, coma and epileptic status, myasthenia gravis, and psychiatric diseases; 4.Patients with a history of alcohol or drug abuse; 5.Severe or very severe chronic obstructive pulmonary disease diagnosed according to the Global Initiative on Chronic Obstructive Pulmonary Disease; 6.Patients with advanced tumors or cachexia (expected survival no more than 3 months); 7.Pregnant women/women who may be pregnant or breastfeeding; 8.Allergic to experimental drugs; 9.Patients who are also participating in other exploratory clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction rate of interleukin-6 (IL-6) after 72 hours of sedative treatment compared to pre-treatment levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival situation in the ICU;Survival situation within the hospital;Total hospital stay;Aspartate aminotransferase;Direct bilirubin;Indirect bilirubin;Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen;The reduction rate of endotoxin after 72 hours of sedative treatment compared to pre-treatment levels;Total bilirubin;Mechanical ventilation time;Anaphylaxis associated with the use of Remimazolam Beaylate;The reduction rate of Tumor necrosis factor-alpha(TNF-a) after 72 hours of sedative treatment compared to pre-treatment levels;creatinine;Urea nitrogen;Ratio of Pulse Oxygen Saturation to Fraction of Inspired Oxygen;28-day survival;Length of stay in intensive care unit;The reduction rate of C-reactive protein(CRP) after 72 hours of sedative treatment compared to pre-treatment levels;Glutamyltransferase; | — |
Countries
China
Contacts
Xi'an Jiaotong University Second Affiliated Hospital