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Observation of the Anti-inflammatory Efficacy of Remimazolam Besylate in Patients with Intubated Acute Respiratory Distress Syndrome: A Multicenter, Prospective Cohort Study

Observation of the Anti-inflammatory Efficacy of Remimazolam Besylate in Patients with Intubated Acute Respiratory Distress Syndrome: A Multicenter, Prospective Cohort Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101293
Enrollment
Unknown
Registered
2025-04-23
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute respiratory distress syndrome

Interventions

Remimazolam Beaylate treatment group:None

Sponsors

Xi'an Jiaotong University Second Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
The reduction rate of interleukin-6 (IL-6) after 72 hours of sedative treatment compared to pre-treatment levels;

Secondary

MeasureTime 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

Public ContactGang Wang

Xi'an Jiaotong University Second Affiliated Hospital

gang_wang@xjtu.edu.cn+86 29 87679633

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026