Clinical Research Directory

Vasoactive Inotropic Score in Adult Cardiac Surgery Outcomes

This study looked at whether a bedside score called the Vasoactive Inotropic Score (VIS) could help doctors predict which adult patients are at higher risk of complications after heart surgery that uses a heart-lung machine (cardiopulmonary bypass). VIS is calculated from the doses of heart-support medications a patient is already receiving after surgery, so it does not require any extra tests or procedures. Researchers measured VIS at five points in the first two days after surgery in 232 adults undergoing a range of heart operations, including valve surgery and coronary artery bypass. The study found that VIS measured soon after surgery, and again at 24 hours, gave useful early warning of which patients were more likely to experience serious complications such as kidney injury, stroke, or the need for additional circulatory support. This information could help hospital teams identify at-risk patients earlier and monitor them more closely.

Terbinafine for CSA-AKI Prevention

Primary Objective: To evaluate the efficacy and safety of perioperative oral terbinafine in reducing the incidence of cardiac surgery-associated acute kidney injury (CSA-AKI).Secondary Objectives:To assess the effects of terbinafine on the severity of post-cardiac surgery AKI, length of hospital stay, and 30-day major adverse kidney events (MAKE30);To evaluate its impacts on biomarkers of renal injury and inflammation.

Artificial Intelligence Evaluation of Fascial Plane Block Quality and Postoperative Pain in Cardiac Surgery

Postoperative pain is a common and significant problem following open heart surgery. Fascial plane blocks (FPBs) such as the serratus anterior plane block (SAPB) and the pecto-intercostal fascial block (PIFB) are increasingly used as part of multimodal analgesia in cardiac surgery. However, objective assessment of block quality and its relationship with clinical outcomes remains limited in the literature. This prospective observational study evaluated the anatomical success of ultrasound-guided fascial plane blocks applied in elective open heart surgery (median sternotomy). Block images were recorded in DICOM format and scored independently and blindly on a 3-point scale by five pre-trained, publicly available large vision-language models used as independent observers via zero-shot prompting (Gemini 3.5 Flash, Claude Sonnet 4.6, ChatGPT 5.5, Grok 4.3, Kimi AI 2.6), by three experienced anaesthesiologists, and by an adjudicator. The primary analysis was the correlation between anatomical block success scores and postoperative pain (Numerical Rating Scale at rest and on coughing). Agreement between AI and human assessments, total analgesic consumption and clinical outcomes were analysed as secondary aims. Note: this registration was originally entered from a superseded version of the protocol. The current approved protocol (version dated 29 April 2026) specifies pre-trained large vision-language models rather than a bespoke convolutional neural network. The record has been corrected accordingly; see Detailed Description.

Dynamic Multimodal Delirium Warning After Cardiac Surgery

After heart surgery, up to half of all patients may develop a state of sudden confusion called postoperative delirium. This condition can lead to longer time on a breathing machine, extended stays in the intensive care unit (ICU), and a slower overall recovery. Currently, doctors have no reliable way to predict delirium early enough to take preventive action. This study aims to build a computer-based early warning system. The system will combine continuous, real-time measurements of brain waves (EEG), the oxygen level in the brain, and heart and blood pressure function. It will also include information about each patient's health status. By analyzing all of these signals together, the model is designed to give an alert 1 to 6 hours before delirium might start, giving the care team a window of time to intervene. The study will take place in the ICU at Zhongda Hospital, Southeast University. Adults between 18 and 80 years old who are admitted to the ICU after heart surgery will be invited to participate. All patients will receive the usual standard of care; the study does not test any new treatment. Participation means the investigators will continuously record the brain, oxygen, and heart signals that are already being monitored, and a researcher will regularly assess the patient's thinking and alertness with a simple bedside check.

Audit of the Revised PACU Centric ERACS Program

A previous audit (S63843) found an association between improved compliance with these interventions and postoperative outcomes (hospital length of stay (LOS) and presence of ≥1 postoperative complication). The investigators found that every 10% increase in compliance was associated with an increased risk (HR=1.25, p=0.0008) for early discharge. In addition, improved compliance was also associated with a reduction (OR=0.60, p=0.0003) of postoperative complications. Based on these findings, improving compliance with current guidelines remains a hurdle that clinicians should overcome. The investigators previous retrospective study was unable to identify the reason for non-compliance and the relation to postoperative outcomes. Therefore, a prospective audit is warranted to assess reach, fidelity, and dose of the different interventions.

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium and Negative Emotions in Patients Undergoing Cardiac Surgery

A multicenter, randomized, double-blind, sham-controlled trial to investigate the effects of intraoperative transcutaneous auricular vagus nerve stimulation (taVNS) on the incidence of postoperative delirium and negative emotional states (anxiety, depression) in patients undergoing elective cardiac surgery.

Diuretic Effect of Aminophylline and Furosemide in Adult Patients Undergoing Cardiac Surgical Procedures

This work aims to investigate the diuretic effect of Aminophylline in comparison to Furosemide in adult patients undergoing cardiac surgical procedures.

Femoral Versus Radial Invasive Arterial Pressure Monitoring in Cardiac Surgery Patients

Background: Acute circulatory failure, often presenting as arterial hypotension, is a major contributor to postoperative morbidity and mortality. Accurate blood pressure (BP) monitoring is essential for timely therapeutic intervention, particularly in patients undergoing major surgery. Among invasive BP measurement sites, the radial artery is commonly used due to its accessibility and ease of catheterization. However, physiologically, the radial artery may underestimate central arterial pressure compared to the femoral artery, especially in patients receiving vasopressors or in critical conditions. This discrepancy can lead to overtreatment with vasopressors and associated complications. Current literature on the accuracy of radial versus femoral BP monitoring is outdated and based solely on observational studies. There is a lack of high-quality randomized data to inform clinical guidelines. Hypothesis: Femoral arterial pressure monitoring, by offering more accurate hemodynamic data, reduces the need for vasopressor support, particularly norepinephrine, compared to radial artery monitoring. Primary Objective: To compare the effect of femoral versus radial invasive BP monitoring on the proportion of patients requiring norepinephrine from anesthetic induction to postoperative day 7 (D7) following elective cardiac surgery. Norepinephrine treatment is defined by continuous intravenous administration of norepinephrine for more than 1 minute. Secondary Objectives : To compare the following outcomes between the two strategies within the first 7 postoperative days: incidence of acute kidney injury (AKI) according to KDIGO criteria, incidence of cardiac complications (arrhythmias requiring treatment, myocardial injury (troponin \>99th percentile or \>20% rise from baseline), myocardial infarction, cardiogenic shock, cardiac arrest), vaso-inotropic score (VIS), duration of any vasopressor therapy (days), ICU and hospital length of stay (days), all-cause mortality at day 7 and day 30, total duration (hours/days) and maximal dose of norepineprhine therapy, intraoperative hypotension episodes (MAP\<65 mmHg \> 5 min), incidence of arterial catheter-related complications (hematoma, bleeding, infection, thrombosis, arterial occlusion, malfunction, dislodgement). Primary Endpoint: The proportion of patients receiving continuous intravenous norepinephrine from anesthesia induction to postoperative day 7. Secondary Endpoints: AKI occurrence or need for renal replacement therapy; cardiac complications: atrial/ventricular arrhythmias requirinf treatment, myocardial injury (troponin \>99th percentile or \>20% rise from baseline), myocardial infarction (biomarker elevation + ECG or echocardiographic abnormalities), cardiogenic shock, cardiac arrest; maximum VIS in the OR, ICU admission, and day 1; intraoperative hypotension episodes (MAP\<65 mmHg \> 5 min); total norepinephrine support duration (in hours); duration of any vasopressor therapy; arterial line complications: malfunction, dislodgement, hematoma, thrombosis, infection, bleeding, arterial occlusion; ICU and hospital length of stay (days); all-cause mortality at day 7 and day 30 Study Design: A prospective, multicenter (Besançon and Dijon University Hospitals), randomized, superiority, single-blind, intention-to-treat clinical trial in adults undergoing elective cardiac surgery. Patients are randomized to femoral or radial artery catheterization for continuous BP monitoring. Sample Size: Based on an expected norepinephrine use rate of 70%, a 15% absolute risk reduction, α = 0.05, and power = 90%, 162 patients per group are required. Accounting for 5% data loss, 340 patients will be enrolled. Study Arms: Radial group: invasive BP monitoring via radial artery catheterization Femoral group: invasive BP monitoring via femoral artery catheterization The arterial line is placed under ultrasound guidance in the operating room and maintained postoperatively in the ICU or critical care unit until no longer clinically indicated. Eligibility Criteria Inclusion: adults patients ≥18 years undergoing elective on-pump cardiac surgery with informed consent. Exclusion: emergency surgery, use of dual arterial lines, heart transplantation, mechanical circulatory support, contraindications to radial/femoral catheterization, legal or ethical inability to consent. Study Timeline Inclusion period: 36 months Patient follow-up: 7 days post-surgery Total study duration: 36 months Data Collection: Clinical data are collected by research staff using an electronic case report form (e-CRF) via CleanWeb™ software. Expected Impact: There are currently no guidelines specifying the optimal site for invasive BP monitoring. This study aims to provide robust evidence on whether femoral BP monitoring improves clinical outcomes, reduces vasopressor use, and minimizes adverse events. Positive findings could inform future practice guidelines and lead to broader investigations in other clinical settings.

In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass

The goal of this observational study is to assess in situ vascular function, glycocalyx and microcirculation in postoperative vasoplegic shock following cardiac surgery with cardiopulmonary bypass. The main question is to investigate the relationship between NO-dependent vasomotor reserve and the presence of vasoplegic shock following cardiac surgery with cardiopulmonary bypass. Participants will have two visits, during which a number of non-invasive examinations will be carried out to study glycocalyx, microcirculation and vascular function. Biological and morphological data will be collected up to 3 months after inclusion, as well as information on treatments administered and outcome. Researchers will compare a group of patients with vasoplegic shock against a group without vasoplegic shock in order to study possible alterations in function in the vasoplegic shock group.