Postoperative Cognitive DysfunctionNCT06268249
Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction
An observational study of Postoperative Cognitive Dysfunction and Postoperative Delirium, run by Qin Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Postoperative Delirium
- What is being tested?
- Ulinastatin
- How many people
- 7,065 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing heart surgery: (coronary artery bypass grafting, heart valve replacement surgery, Morrow procedure, aortic dissection surgery).
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction by Inhibiting Glycocalyx Degradation: An Observational Study
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.
Read the detailed description
- 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
- 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, Hyaluronic acid, etc.). Operation time Vital signs (temperature, pulse, respiration, blood pressure) Routine blood chemistry and arterial blood gas analysis Document vasoactive drug use
- 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.)
- 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: (heart valve replacement surgery with CPB,coronary artery bypass grafting, Morrow procedure, aortic dissection surgery).
Exclusion criteria:
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 Delirium, postoperative cognitive dysfunction. Objective: Analyze the correlation between polysaccharide coating and cardiac surgery-related indicators.
- Being tested
- Ulinastatin
- Keywords
- POCD - Postoperative Cognitive Dysfunction, POD-Postoperative Delirium
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlinastatinDrug
Ulinastatin was pumped continuously during the operation
What is being measured
The primary outcome is the main question the study is designed to answer.
POCD - Postoperative Cognitive Dysfunction
Mini-Mental State Examination(MMSE)
Measured: 24 hours
POD-postoperative delirium
Confusion Assessment Method for the ICU (CAM-ICU)
Measured: 7 days
Secondary outcomes (1)
Survival time
Questionnaire
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jan 2015
- Primary completion30 Dec 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,065 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qin Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Zhang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268249
- Sponsor's protocol ID
- TJ-IRB20231224
- Status last verified
- Oct 2024
- First submitted
- 4 Feb 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39881341
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction by Inhibiting Glycocalyx Degradation: An Observational Study
- ClinicalTrials.gov ID
- NCT06268249
- Acronym / sponsor ID
- TJ-IRB20231224
- Keywords
- POCD - Postoperative Cognitive Dysfunction, POD-Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,065 participants (actual)
- Lead sponsor
- Qin ZhangUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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
- 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, Hyaluronic acid, etc.). Operation time Vital signs (temperature, pulse, respiration, blood pressure) Routine blood chemistry and arterial blood gas analysis Document vasoactive drug use
- 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.)
- 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: (heart valve replacement surgery with CPB,coronary artery bypass grafting, Morrow procedure, aortic dissection surgery).
Exclusion criteria:
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 Delirium, postoperative cognitive dysfunction. Objective: Analyze the correlation between polysaccharide coating and cardiac surgery-related indicators.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing heart surgery: (coronary artery bypass grafting, heart valve replacement surgery, Morrow procedure, aortic dissection surgery).
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UlinastatinUlinastatin was pumped continuously during the operation | Drug | – |
Primary outcome
POCD - Postoperative Cognitive Dysfunction
Time frame: 24 hours
Mini-Mental State Examination(MMSE)
POD-postoperative delirium
Time frame: 7 days
Confusion Assessment Method for the ICU (CAM-ICU)
1 secondary outcome
Survival time
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 39881341Ran 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction and Postoperative Delirium, run by Qin Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POCD - Postoperative Cognitive Dysfunction (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06268249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.