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

NCT06276569 | Completed Phase 3

• 1 other identifier: 2023-LCYJ-MS-26
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the effectiveness and safety of sivelestat sodium in preventing acute lung injury and/or acute respiratory distress syndrome (ALI/ARDS) following cardiac surgery, with the objective of providing evidence-based support for its clinical application.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (9)

• Oxygenation index

  SpO2 /FIO2

  postoperative day 1, 3, 5 and 7

• Inflammatory index

  WBC\[×109/L\], Neutrophil\[NEU,%\], Interleukin(IL)-1β\[pg/mL\], IL-6\[pg/mL\], IL-8\[pg/mL\], TNF-α\[pg/mL\], CRP\[mg/L\], PCT\[ng/mL\], neutrophil elastase\[NE,ng/mL\] and myeloperoxidase\[MPO, ng/ml\]

  postoperative day 1, 3, 5 and 7

• Myocardial injury marker

  myoglobin\[Myo, ng/ml\], CK-MB\[ng/ml\], hs-cTnI\[ng/ml\]

  postoperative day 1, 3, 5 and 7

• Acute physiology and chronic health evaluation(APACHE II) socre

  Interpretation of APACHE II : minimum 0 and maximum 71; increasing score is associated with an increasing risk of hospital death. acute physiology score, chronic health status score, and age adjustment score

  postoperative day 1, 3, 5 and 7

• Murray socre

  Interpretation of Murray socre : the Murray Lung Injury Score, a clinical assessment tool for evaluating the severity of acute lung injury. The score ranges from 0 to 4, with higher scores indicating worse pulmonary function and more severe lung injury.

  postoperative day 1, 3, 5 and 7

• ICU time

  Time to stay in the intensive care unit

  postoperative 28 days

• In-hospital time

  All time during hospitalization

  postoperative 28 days

• 30-day all-cause mortality

  Proportion of deaths caused by various reasons within a certain period of time (30 days) compared to the total number of people in a certain group

  postoperative 30 dayS

• 90-day all-cause mortality

  Proportion of deaths caused by various reasons within a certain period of time (90 days) compared to the total number of people in a certain group

  postoperative 90 days

Study Arms (2)

sivelestat group

EXPERIMENTAL

sivelestat was dissolved in 0.9% sodium chloride injection and diluted with 50ml of the same solution to achieve a dose of 4.8mg/kg/day; this mixture was then placed in a sealed package and administered intravenously at a rate of 0.2 mg/kg/h for seven consecutive days.

Drug: Sivelestat

placebo comparator

PLACEBO COMPARATOR

received an equivalent volume (50ml) of saline continuously administered intravenously at a rate of 0.2 mg/kg/hour.

Other: placebo

Interventions

Sivelestat DRUG

(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.

sivelestat group

placebo OTHER

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.

placebo comparator

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 50 and 80 years old.
• Both sexes.
• Patients undergoing elective cardiac surgery;informed consent.

You may not qualify if:

• Patients undergoing emergency surgery.
• Patients undergoing deep hypothermic circulatory arrest surgery;.
• Patients with liver and kidney dysfunction (Child-Pugh class B or C, estimated glomerular filtration rate \<35 mL/min/1.73 m2).
• Patients with abnormal baseline inflammatory markers \[interleukin-6 (IL6) \>10 pg/mL, procalcitonin (PCT) \>0.5 ng/mL, C-reactive protein (CRP) \>10 mg/L\].
• Patients diagnosed with inflammatory immune disease, infectious disease, or oncological disease; patients receiving other medications that inhibit neutrophil elastase (e.g., ulinastatin, alpha 1-antiprotease).
• Patients allergic to or intolerant to sodium sivelestat.
• Pregnant.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, China

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

sivelestat

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Tuo Pan, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 26, 2024
• Study Start: February 18, 2024
• Primary Completion: April 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)