Ulinastatin Reduces Postoperative Pulmonary Complications in Cardiac Surgery

NCT07237243 | Completed

• 1 other identifier: TJ-IRB 202411033
• Study Type: observational
• Target: 4,540
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the association between intraoperative ulinastatin administration and PPCs incidence in cardiac surgery. It comprises three core components: an innovative retrospective analysis, a bioinformatics study integrating network pharmacology and molecular docking, and a clinical cohort study. Figure 1 presents a flowchart of the three-phase study, including participant screening procedures, key sample collection time points, and the analytical framework.

Conditions

Pulmonary Complication; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative Pulmonary Complications (PPCs)

  The diagnostic criteria for PPCs were based on the definitions outlined in the European Perioperative Clinical Outcome definitions, published jointly by the European Society of Anaesthesiology and the European Society of Intensive Care Medicine in 2015.In the present study, PPCs included respiratory tract infections, respiratory failure, pleural effusion, atelectasis, bronchospasm, and aspiration pneumonia.

  7 days

Secondary Outcomes (2)

• Postoperative delirium

  7 days

• In-hospital all-cause mortality

  7 days

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective cardiac surgery, including open-heart valve repair, valve replacement with cardiopulmonary bypass, and off-pump coronary artery bypass grafting.

You may qualify if:

• Adult patients undergoing elective cardiac surgery, including open-heart valve repair, valve replacement with cardiopulmonary bypass, and off-pump coronary artery bypass grafting, were consecutively screened for eligibility.

You may not qualify if:

• (1) age \< 18 years; (2) pregnant women; (3) history of prior cardiac surgery before the current hospitalization; (4) presence of acute respiratory diseases prior to surgery, such as respiratory tract infections, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and pneumonia; (5) administration of ulinastatin therapy prior to cardiac surgery during the current hospitalization; (6) The drug ulinastatin was utilized during the surgery, with a total intraoperative dose of less than 50,000 U; (7) history of malignancy or bone marrow transplantation.

Sponsors & Collaborators

• Qin Zhang: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: January 1, 2014
• Primary Completion: December 30, 2022
• Study Completion: September 30, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CN (1)