Venous Congestion And Cognitive Dysfunction After Cardiac Surgery

NCT07483151 | Recruiting DMC

• 1 other identifier: 20251218
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Intraoperative Venous Congestion And Cognitive Dysfunction After Cardiac Surgery

Keywords

Venous Congestion; Cardiac Surgery; Postoperative cognitive dysfunction (POCD)

Outcome Measures

Primary Outcomes (1)

• Postoperative cognitive dysfunction after surgery

  Postoperative cognitive dysfunction (POCD) is assessed using Mini-Mental State Examination (MMSE).

  day 7, day 15, month 1, month 3, and month 6 after surgery

Study Arms (1)

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.

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

Interventions

surgery-related parameters OTHER

1. 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.

Adult patients scheduled to undergo elective cardiac surgery

POCD assessments OTHER

Assessments of POCD at day 7, day 15, month 1, month 3, and month 6 postoperatively.

Adult patients scheduled to undergo elective cardiac surgery

collection of biological (laboratory) parameters OTHER

1. 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.

Adult patients scheduled to undergo elective cardiac surgery

collection of hemodynamic parameters OTHER

1. 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.

Adult patients scheduled to undergo elective cardiac surgery

collection of parameters monitoring on the central nervous system OTHER

1. Regional cerebral oximetry. 2. Brain wave patterns. 3. Optic nerve sheath diameter.

Adult patients scheduled to undergo elective cardiac surgery

collection of demographic characteristics and comorbidities OTHER

1. 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.

Adult patients scheduled to undergo elective cardiac surgery

collection of echocardiographic parameters and venous ultrasound assessments OTHER

(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.

Adult patients scheduled to undergo elective cardiac surgery

Eligibility Criteria

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

Study Population

Patients scheduled to undergo elective cardiac surgery

You may qualify if:

• 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.

You may not qualify if:

• 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%;
• 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;

Sponsors & Collaborators

• Zhuan Zhang: lead

Study Sites (1)

The Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, 225012, China

RECRUITING

MeSH Terms

Conditions

Hyperemia; Postoperative Cognitive Complications

Interventions

Comorbidity; Laboratories

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Non-Medical Public and Private Facilities; Health Facilities; Health Care Facilities Workforce and Services

Central Study Contacts

Zhuan Zhang, MD

CONTACT

+8615062791355; zhangzhuancg@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, the Deputy Director of Anesthesiology, the Affiliated Hospital of Yangzhou University, Yangzhou University

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 19, 2026
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)