Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Lung Injury or Acute Respiratory Distress Syndrome After Cardiac Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

382

Participants

Timeline

Start Date

February 18, 2024

Primary Completion Date

April 30, 2025

Study Completion Date

July 30, 2025

Conditions
Cardiac Disease
Interventions
DRUG

Sivelestat

(1)Experimental group: Received intravenous sivelestat sodium admission to the ICU. Sivelestat sodium was dissolved in 0.9% sodium chloride injection and a one-day dose (4.8mg/kg) was diluted in 50ml of 0.9% sodium chloride injection, which was then sealed for continuous intravenous administration at a rate of 0.2 mg/kg/h for seven consecutive days.

OTHER

placebo

2)Control group: Receiving the same dose of placebo, 50 ml of saline, were administered intravenously at a rate of 0.2 mg/kg throughout the treatment period without any discernible impact on patient's regular treatment regimen.

Trial Locations (1)

Unknown

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing

All Listed Sponsors
lead

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

NCT06276569 - Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Lung Injury or Acute Respiratory Distress Syndrome After Cardiac Surgery | Biotech Hunter | Biotech Hunter