Venous Congestion And Delirium After Cardiac Surgery

Official title

Intraoperative Venous Congestion And Delirium After Cardiac Surgery: A Prospective Cohort Study

Overview

Postoperative delirium (POD) is an acute brain dysfunction characterized by inattention, impaired consciousness, and cognitive and orientation disturbances, and is a common complication after cardiac surgery. The high incidence of up to 52% of POD in cardiac surgery patients lead to a range of adverse clinical outcomes.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 POD 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.

Interventions

• Other collection of demographic characteristics and comorbidities
  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.
• Other surgery-related parameters
  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 s
• Other POD assessments
  Assessments of POD during the first 7 days postoperatively.
• Other collection of biological (laboratory) parameters
  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.
• Other collection of hemodynamic parameters
  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.
• Other 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
• Other collection of parameters monitoring on the central nervous system
  1. Regional cerebral oximetry. 2. Brain wave patterns. 3. Optic nerve sheath diameter.

Primary outcome measures

• Postoperative delirium after surgery [Time frame: 7 days after surgery]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• Documented delirium before surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• No. 368 Hanjiang Middle Road — Yangzhou

Identifiers

NCT: NCT07285187 · 20240915

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗