Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction

NCT06268249 | Completed

• 1 other identifier: TJ-IRB20231224
• Study Type: observational
• Target: 7,065
• Locations: 1 country
• Sites: 1

Brief Summary

The study comprised two primary components: a retrospective analysis of clinical big data and a conventional prospective cohort study involving patients undergoing cardiac surgery. The objectives were: 1. To assess the preventive effect of ursodeoxycholic acid on post-cardiac surgery cognitive dysfunction over an eight-year period. 2. To analyze preoperative and postoperative 24-hour plasma samples from prior studies to quantify the levels of glycocalyx and its associated regulatory factors. 3. To evaluate the clinical association between the measured parameters and patient outcomes.

Conditions

Postoperative Cognitive Dysfunction; Postoperative Delirium

Keywords

POCD - Postoperative Cognitive Dysfunction; POD-Postoperative Delirium

Outcome Measures

Primary Outcomes (2)

• POCD - Postoperative Cognitive Dysfunction

  Mini-Mental State Examination（MMSE）

  24 hours

• POD-postoperative delirium

  Confusion Assessment Method for the ICU (CAM-ICU)

  7 days

Secondary Outcomes (1)

• Survival time

  28 days

Interventions

Ulinastatin DRUG

Ulinastatin was pumped continuously during the operation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing heart surgery: (coronary artery bypass grafting, heart valve replacement surgery, Morrow procedure, aortic dissection surgery).

You may qualify if:

• Voluntary participation in the study;
• Age ≥ 18 years and ≤ 80 years;
• Patients undergoing heart surgery: (coronary artery bypass grafting, heart valve replacement surgery, Morrow procedure, aortic dissection surgery).

You may not qualify if:

• Patients experiencing adverse events during the surgery;
• Recipients of solid organ or bone marrow transplants;
• Patients with autoimmune diseases, tumors, or who have received high-dose steroids or immunosuppressive therapy within the past 2 months;
• Deemed unsuitable for participation in this study by the researchers.

Sponsors & Collaborators

• Qin Zhang: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• Ran X, Xu T, Liu J, Yang S, Luo F, Wu R, Tan J, Ruan H, Zhang Q. Ulinastatin treatment mitigates glycocalyx degradation and associated with lower postoperative delirium risk in patients undergoing cardiac surgery: a multicentre observational study. Crit Care. 2025 Jan 29;29(1):52. doi: 10.1186/s13054-025-05296-9.

  PMID: 39881341 DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications; Emergence Delirium

Interventions

urinastatin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

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: February 4, 2024
• First Posted: February 20, 2024
• Study Start: January 1, 2015
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)