Perioperative Cerebral Function Assessment for Cardiac Surgery

Recruiting

• Conditions: Cardiac Surgery

• Registration Number: NCT06660602
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. This study is aimed at identifying the specific risk factors associated with these neurological complications during the perioperation and developing a comprehensive predictive model designed to enhance clinical decision-making and improve patient safety. The research is divided into three key phases: preoperative, intraoperative, and postoperative, each involving targeted evaluations and continuous monitoring to provide a thorough assessment of patient risk and outcomes.

Detailed Description

Before operation, a thorough assessment is conducted, encompassing a detailed analysis of participants' medical histories, demographic profiles, cerebrovascular structure, and cerebral function. These variables are systematically examined to identify risk factors for neurological complications.

Intraoperatively, real-time monitoring of cerebral blood flow and regional oxygen saturation is conducted using advanced techniques, including transcranial Doppler ultrasound and near-infrared spectroscopy, to evaluate the impact of surgical procedures on cerebral perfusion and oxygenation.

Postoperative monitoring emphasizes the identification of potential complications, such as cognitive dysfunction, seizures, delirium, and stroke. By integrating data from all stages during perioperation, the investigators want to develop a predictive model for perioperative brain function assessment. This model is intended to provide clinicians with a reliable tool for more precise risk assessment and timely intervention, thereby reducing the incidence of neurological complications and improving the prognosis for patients.

Study Timeline

• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-28
• Study Start: 2025-02-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2028-06
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1845

Inclusion Criteria

Not provided

Exclusion Criteria

1. Inability to tolerate required diagnostic procedures, including neck CT angiography (CTA), head CT perfusion (CTP), or electroencephalography (EEG), due to underlying physical limitations or medical contraindications;
2. Severe renal insufficiency, characterized by a creatinine clearance of less than 30 mL/min (using the Cockcroft-Gault formula), serum creatinine levels exceeding twice the upper limit of normal, or any other form of clinically significant renal impairment;
3. Severe hepatic dysfunction, defined by ALT or AST levels greater than three times the upper limit of normal, or the presence of hepatic conditions such as acute or chronic hepatitis, cirrhosis, or other significant liver disorders;
4. Comorbid conditions that may compromise study participation or pose substantial risk to the patient, including, but not limited to, alcohol or substance abuse, malignancies, and severe diseases affecting the liver, kidneys, lungs, endocrine system (e.g., uncontrolled diabetes or thyroid disorders), or hematopoietic system;
5. Inability to cooperate with study procedures, whether due to cognitive, psychological, or physical factors that would impede compliance with protocol requirements;
6. Other conditions deemed unsuitable by the investigator, including any medical or non-medical factors that, in the investigator's assessment, may preclude safe or effective participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurological complications within 7 (±3) days post-surgery including fatal or non-fatal stroke, coma, or movement disorders; cognitive dysfunction or delirium	From enrollment to the post-surgery within 7 (±3) days

Trial Locations

Locations (1)

Department of Neurology, Fuwai Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China