An observational study in Intraoperative Venous Congestion And Cognitive Dysfunction After Cardiac Surgery, sponsored by Zhuan Zhang. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Zhuan Zhang · Observational
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.
Patients scheduled to undergo elective cardiac surgery
Exclusion Criteria:
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
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.
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.
Assessments of POCD at day 7, day 15, month 1, month 3, and month 6 postoperatively.
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.
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.
(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.
1. Regional cerebral oximetry. 2. Brain wave patterns. 3. Optic nerve sheath diameter.
Postoperative cognitive dysfunction after surgery
Postoperative cognitive dysfunction (POCD) is assessed using Mini-Mental State Examination (MMSE).
Time frame: day 7, day 15, month 1, month 3, and month 6 after surgery
Plan to share: No
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Zhuan Zhang