Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction

Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction by Inhibiting Glycocalyx Degradation: An Observational Study

This study is a retrospective, observational study that aims to include patients undergoing cardiac surgery. 1. Evaluate the preventive effect of ursodeoxycholic acid on post-cardiac surgery cognitive dysfunction over the past eight years. 2. Utilize the pre-existing preoperative and postoperative 24-hour plasma samples from previous studies to measure the levels of glycocalyx and its related regulatory factors. 3. Assess the clinical correlation between the measured parameters and patient outcomes.

Study Overview

• Status: Completed
• Conditions: Cardiac Complication
• Intervention / Treatment: Drug: Ulinastatin

Detailed Description

1. Baseline Period Visit 1 (within 24 hours before surgery)

   Sign informed consent Check inclusion/exclusion criteria Demographic data (sex, age, occupation, etc.) Past medical history (stroke, hypertension, diabetes, dyslipidemia, coronary heart disease, diabetes, etc.) and medication history in the past 3 months Vital signs (temperature, pulse, respiration, blood pressure) Preoperative ECG Preoperative echocardiography Laboratory tests (blood routine, blood glucose, blood lipids, liver and kidney function, myocardial enzymes, blood electrolytes, coagulation function) Concomitant therapy Adverse events

2. Intraoperative cardiopulmonary bypass

   Record vital signs and various physiological indicators in the operating room. Routinely perform central venous puncture to establish venous access and monitor central venous pressure, and radial artery puncture to monitor invasive arterial pressure.

   After general anesthesia and endotracheal intubation, routine blood chemistry and arterial blood gas analysis were performed.

   After collecting the above blood samples for testing, the remaining blood was centrifuged, and the plasma was frozen at -80°C for subsequent testing (levels of CRP, IL-6, IL-10, TNF-α, TK/B1R/MMP3, etc.).

   Operation time Vital signs (temperature, pulse, respiration, blood pressure) Routine blood chemistry and arterial blood gas analysis Document vasoactive drug use

3. 24 hours, 72 hours, 7 days after surgery

   Vital signs (temperature, pulse, respiration, blood pressure) Bedside echocardiography Laboratory tests (blood routine, blood sugar, blood lipids, liver and kidney function, myocardial enzymes, coagulation function, etc.) After collecting the above blood samples for testing, the remaining blood is centrifuged, and the plasma is frozen at -80°C for later testing (levels of glycocalyx) POCD Document treatment regimen (including vasoactive drug use, etc.)

4. Follow-up period

CCU time and total hospital stay 28-day survival status The survival status of the patients was followed up, and the date of death and the cause of death should be recorded in the patients who died.

Research Evaluation Analyze the clinical correlation between glycocalyx and its related indicators and postoperative cognitive dysfunction after cardiac surgery.

Patient Completion/Withdrawal from Study Finish All evaluation data of the patients 28 days after the operation were completely collected and considered as completed cases.

Inclusion criteria:

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).

Exclusion criteria:

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. Primary outcome: postoperative cognitive dysfunction. Objective: Analyze the correlation between polysaccharide coating and cardiac surgery-related indicators.

• Study Type: Observational
• Enrollment (Actual): 7065

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POCD - Postoperative Cognitive Dysfunction	Mini-Mental State Examination（MMSE）	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival time	Questionnaire	28 days

Collaborators and Investigators

• Sponsor: Qin Zhang

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: POCD - Postoperative Cognitive Dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Trypsin Inhibitors; Urinastatin
• Other Study ID Numbers: TJ-IRB20231224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No