Intraoperative Venous Congestion And Cognitive Dysfunction After Cardiac SurgeryNCT07483151
Venous Congestion And Cognitive Dysfunction After Cardiac Surgery
An observational study of Intraoperative Venous Congestion And Cognitive Dysfunction After Cardiac Surgery, run by Zhuan Zhang at 1 site in China.
Trial summary
Postoperative cognitive dysfunction (POCD) is a common central nervous system complication after surgery and anesthesia. Its primary clinical manifestations include a significant decline in cognitive abilities after surgery and anesthesia, encompassing memory, attention, coordination, orientation, language fluency… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Venous Congestion And Cognitive Dysfunction After Cardiac Surgery
- What is being tested?
- collection of demographic characteristics and comorbidities, surgery-related parameters and POCD assessments
- Type of treatment
- Injection or infusion
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo elective cardiac surgery
Who may be able to join
- Patients scheduled to undergo elective cardiac surgery via a midline thoracic incision;
- ≥18 years;
- A preoperative MMSE score>23, without consciousness or language barriers, capable of cooperating with neurological examinations, cognitive function tests, and other assessments of neurological function.
Who cannot join
- Contraindications for TEE;
- Emergency cardiac surgery;
- Major vascular surgery;
- Redo cardiac surgery;
- Severe infection requiring continuous antibiotic therapy;
- Severe preoperative heart failure with left ventricular ejection fraction < 30%;
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- A critical preoperative state (mechanical circulatory support, extracorporeal membrane oxygenation, current renal replacement therapy, mechanical ventilation, or cardiac arrest necessitating resuscitation);
- Multi-organ dysfunction;
- Known conditions that may interfere with the assessment or interpretation of hepatic vein, portal vein blood flow (such as liver cirrhosis or portal vein thrombosis) or the renal vein blood flow (such as urinary tract obstruction);
- Planned cardiac transplantation or ventricular assist device implantation;
- Pregnancy;
- Insufficient ultrasonographic imaging;
- Restarting CPB after first CPB cessation during surgery;
- Requirement for cardiac assist devices (ECMO, IABP, or ventricular assist device) after CPB intraoperatively;
- Neurological or psychiatric diagnoses that may affect cognitive performance or cognitive testing;
- Documented delirium before surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu, 225012
About this study
Official title: Intraoperative Venous Congestion And Cognitive Dysfunction After Cardiac Surgery: A Prospective Cohort Study
Postoperative cognitive dysfunction (POCD) is a common central nervous system complication after surgery and anesthesia. Its primary clinical manifestations include a significant decline in cognitive abilities after surgery and anesthesia, encompassing memory, attention, coordination, orientation, language fluency, and executive function. POCD may persist for weeks or even years, affecting patient recovery, prolonging hospital stays, and potentially leading to additional physical and mental illnesses, increased mortality, and a significant burden on patients and their families. In cardiac surgery patients, the incidence of POCD ranges from 30% to 80% in the weeks following the procedure. The brain tissue is enclosed in a rigid anatomical structure; when there is an obstruction to venous return from the brain, intracranial pressure can increase, and blood supply to the brain tissue can decrease, leading to central nervous system dysfunction.
Systemic venous congestion can occur when there is right heart dysfunction or excessive volume load. When right heart failure and/or volume overload occurs, changes in right atrial pressure are transmitted to the venous system of organs throughout the body, with dilatation of the inferior vena cava (IVC), obstruction of blood return from the hepatic, portal, and renal veins, and abnormal venous flow signals and altered ultrasound Doppler flow patterns.
The primary objective of this prospective cohort study is to explore if intraoperative systemic venous congestion is associated with POCD after cardiac surgery. This study will also investigate the relationship between intraoperative systemic venous congestion and postoperative complications, and the relationship between each separate venous congestion and POD after cardiac surgery.
- Being tested
- collection of demographic characteristics and comorbidities, surgery-related parameters, POCD assessments, collection of biological (laboratory) parameters, collection of hemodynamic parameters
- Keywords
- Venous Congestion, Cardiac Surgery, Postoperative cognitive dysfunction (POCD)
- Medical subject headings
- Hyperemia, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of demographic characteristics and comorbiditiesOther
- gender, age, BMI, ASA classification, NYHA (New York Heart Association) classification, MMSE score.
- smoking history, medical history (hypertension, diabetes mellitus, Hyperlipidemia, stroke, anaemia, chronic obstructive pulmonary disease, pulmonary hypertension, preoperative atrial fibrillation, peripheral artery disease), preoperative ACEI, ARB, beta-blockers, loop diuretics, aspirin, and spironolactone use.
surgery-related parametersOther
- surgery type, surgery duration, CPB duration, aortic cross-clamp duration, blood loss, intraoperative fluid infusion, intraoperative urine output, intraoperative blood transfusion, intraoperative anesthetics and vasoactive medications.
- duration of mechanical ventilation, duration of vasopressor support, postoperative acute kidney injury incidence and CRRT initiation, major bleeding, deep sternal wound infection/mediastinitis, surgical re-intervention, ICU LOS, hospital LOS, postoperative stroke, complications up to 30 days after surgery, 30-day inpatient mortality, survival status at discharge, and one year follow-up.
- a composite endpoint of major complications after surgery defined as at least one of the following: death, prolonged ventilation (>24 h), stroke, severe AKI, deep sternal wound infection, and reoperation for any reason.
POCD assessmentsOther
Assessments of POCD at day 7, day 15, month 1, month 3, and month 6 postoperatively.
collection of biological (laboratory) parametersOther
- WBC, CRP, IL-6, IL-10, IL-1β, TNF-α, serum Amyloid A, procalcitonin, catecholamines, cortisol, SOD, HIF-1α;
- BDNF, S-100β protein, NSE;
- CK-MB, NT pro-BNP, BNP, high-sensitivity troponin level;
- hemoglobin, hematocrit, sodium, arterial lactate, and liver enzymes.
collection of hemodynamic parametersOther
- blood pressure, heart rate, CVP;
- CO, CI, SV, SVI,SVV;
- intra-abdominal pressure;
- vasoactive drug doses in the first hour in the ICU.
collection of echocardiographic parameters and venous ultrasound assessmentsOther
(1) Left ventricle systolic function, including LVOT, LVEF, MPI; left ventricular diastolic function, including mitral flow-derived Doppler indices, pulmonary vein Doppler indices. (2) Right ventricular systolic function, including TAPSE. Right ventricular diastolic dysfunction, inferred from an abnormal hepatic vein flow (systolic velocity < diastolic velocity) in the absence of a dysrhythmia or pacing. (3) Inferior vena cava (IVC) measurements. (4) Hepatic vein Doppler parameters. (5) Portal vein Doppler parameters. (6) Renal vein Doppler parameters.
collection of parameters monitoring on the central nervous systemOther
- Regional cerebral oximetry.
- Brain wave patterns.
- Optic nerve sheath diameter.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients scheduled to undergo elective cardiac surgery | 1. Patients scheduled to undergo elective cardiac surgery via a midline thoracic incision;
2. ≥18 years;
3. A preoperative MMSE score>23, without consciousness or language barriers, capable of cooperating with neurological examinations, cognitive function tests, and other assessments of neurological function. Receives: Other: collection of demographic characteristics and comorbidities; Other: surgery-related parameters; Other: POCD assessments; Other: collection of biological (laboratory) parameters; Other: collection of hemodynamic parameters; Other: collection of echocardiographic parameters and venous ultrasound assessments; Other: collection of parameters monitoring on the central nervous system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cognitive dysfunction after surgery
Postoperative cognitive dysfunction (POCD) is assessed using Mini-Mental State Examination (MMSE).
Measured: day 7, day 15, month 1, month 3, and month 6 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Nov 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Venous Congestion And Cognitive Dysfunction After Cardiac SurgeryStudies 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
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuan Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483151
- Sponsor's protocol ID
- 20251218
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Venous Congestion And Cognitive Dysfunction After Cardiac Surgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07483151
- Acronym / sponsor ID
- 20251218
- Keywords
- Venous Congestion, Cardiac Surgery, Postoperative cognitive dysfunction (POCD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Zhuan ZhangUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 19 Mar 2026 (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.
Postoperative cognitive dysfunction (POCD) is a common central nervous system complication after surgery and anesthesia. Its primary clinical manifestations include a significant decline in cognitive abilities after surgery and anesthesia, encompassing memory, attention, coordination, orientation, language fluency, and executive function. POCD may persist for weeks or even years, affecting patient recovery, prolonging hospital stays, and potentially leading to additional physical and mental illnesses, increased mortality, and a significant burden on patients and their families. In cardiac surgery patients, the incidence of POCD ranges from 30% to 80% in the weeks following the procedure. The brain tissue is enclosed in a rigid anatomical structure; when there is an obstruction to venous return from the brain, intracranial pressure can increase, and blood supply to the brain tissue can decrease, leading to central nervous system dysfunction.
Systemic venous congestion can occur when there is right heart dysfunction or excessive volume load. When right heart failure and/or volume overload occurs, changes in right atrial pressure are transmitted to the venous system of organs throughout the body, with dilatation of the inferior vena cava (IVC), obstruction of blood return from the hepatic, portal, and renal veins, and abnormal venous flow signals and altered ultrasound Doppler flow patterns.
The primary objective of this prospective cohort study is to explore if intraoperative systemic venous congestion is associated with POCD after cardiac surgery. This study will also investigate the relationship between intraoperative systemic venous congestion and postoperative complications, and the relationship between each separate venous congestion and POD after cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients scheduled to undergo elective cardiac surgery | – | Other: collection of demographic characteristics and comorbidities, Other: surgery-related parameters, Other: POCD assessments, Other: collection of biological (laboratory) parameters, Other: collection of hemodynamic parameters, Other: collection of echocardiographic parameters and venous ultrasound assessments, Other: collection of parameters monitoring on the central nervous system1. Patients scheduled to undergo elective cardiac surgery via a midline thoracic incision; 2. ≥18 years; 3. A preoperative MMSE score>23, without consciousness or language barriers, capable of cooperating with neurological examinations, cognitive function tests, and other assessments of neurological function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo elective cardiac surgery
Key inclusion criteria (3 listed)
- Patients scheduled to undergo elective cardiac surgery via a midline thoracic incision;
- ≥18 years;
- A preoperative MMSE score>23, without consciousness or language barriers, capable of cooperating with neurological examinations, cognitive function tests, and other assessments of neurological function.
Key exclusion criteria (16 listed)
- Contraindications for TEE;
- Emergency cardiac surgery;
- Major vascular surgery;
- Redo cardiac surgery;
- Severe infection requiring continuous antibiotic therapy;
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 |
|---|---|---|
| collection of demographic characteristics and comorbidities1. gender, age, BMI, ASA classification, NYHA (New York Heart Association) classification, MMSE score. 2. smoking history, medical history (hypertension, diabetes mellitus, Hyperlipidemia, stroke, anaemia, chronic obstructive pulmonary disease, pulmonary hypertension, preoperative atrial fibrillation, peripheral artery disease), preoperative ACEI, ARB, beta-blockers, loop diuretics, aspirin, and spironolactone use. | Other | Adult patients scheduled to undergo elective cardiac surgery |
| surgery-related parameters1. surgery type, surgery duration, CPB duration, aortic cross-clamp duration, blood loss, intraoperative fluid infusion, intraoperative urine output, intraoperative blood transfusion, intraoperative anesthetics and vasoactive medications. 2. duration of mechanical ventilation, duration of vasopressor support, postoperative acute kidney injury incidence and CRRT initiation, major bleeding, deep sternal wound infection/mediastinitis, surgical re-intervention, ICU LOS, hospital LOS, postoperative stroke, complications up to 30 days after surgery, 30-day inpatient mortality, survival status at discharge, and one year follow-up. 3. a composite endpoint of major complications after surgery defined as at least one of the following: death, prolonged ventilation (>24 h), stroke, severe AKI, deep sternal wound infection, and reoperation for any reason. | Other | Adult patients scheduled to undergo elective cardiac surgery |
| POCD assessmentsAssessments of POCD at day 7, day 15, month 1, month 3, and month 6 postoperatively. | Other | Adult patients scheduled to undergo elective cardiac surgery |
| collection of biological (laboratory) parameters1. WBC, CRP, IL-6, IL-10, IL-1β, TNF-α, serum Amyloid A, procalcitonin, catecholamines, cortisol, SOD, HIF-1α; 2. BDNF, S-100β protein, NSE; 3. CK-MB, NT pro-BNP, BNP, high-sensitivity troponin level; 4. hemoglobin, hematocrit, sodium, arterial lactate, and liver enzymes. | Other | Adult patients scheduled to undergo elective cardiac surgery |
| collection of hemodynamic parameters1. blood pressure, heart rate, CVP; 2. CO, CI, SV, SVI,SVV; 3. intra-abdominal pressure; 4. vasoactive drug doses in the first hour in the ICU. | Other | Adult patients scheduled to undergo elective cardiac surgery |
| collection of echocardiographic parameters and venous ultrasound assessments(1) Left ventricle systolic function, including LVOT, LVEF, MPI; left ventricular diastolic function, including mitral flow-derived Doppler indices, pulmonary vein Doppler indices. (2) Right ventricular systolic function, including TAPSE. Right ventricular diastolic dysfunction, inferred from an abnormal hepatic vein flow (systolic velocity < diastolic velocity) in the absence of a dysrhythmia or pacing. (3) Inferior vena cava (IVC) measurements. (4) Hepatic vein Doppler parameters. (5) Portal vein Doppler parameters. (6) Renal vein Doppler parameters. | Other | Adult patients scheduled to undergo elective cardiac surgery |
| collection of parameters monitoring on the central nervous system1. Regional cerebral oximetry. 2. Brain wave patterns. 3. Optic nerve sheath diameter. | Other | Adult patients scheduled to undergo elective cardiac surgery |
Primary outcome
Postoperative cognitive dysfunction after surgery
Time frame: day 7, day 15, month 1, month 3, and month 6 after surgery
Postoperative cognitive dysfunction (POCD) is assessed using Mini-Mental State Examination (MMSE).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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.
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 Intraoperative Venous Congestion And Cognitive Dysfunction After Cardiac Surgery, run by Zhuan 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 16 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhuan Zhang, MD (+8615062791355, zhangzhuancg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cognitive dysfunction after surgery (time frame: day 7, day 15, month 1, month 3, and month 6 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.