Clinical Research Directory

Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery

This multicenter pilot randomized controlled trial will evaluate whether providing treating physicians with a structured hemodynamic assessment influences care after cardiac surgery. The assessment combines point-of-care ultrasound, including the Venous Excess UltraSound (VExUS) score to assess fluid tolerance, with monitoring using the Swan-Ganz IQ catheter and HemoSphere Alta system to assess fluid responsiveness. Participants will be randomized to a structured hemodynamic assessment strategy or standard care. In the intervention group, treating physicians will receive a report of the structured assessment findings upon admission to the intensive care unit and on postoperative day 1. The co-primary objectives are to evaluate the impact of the structured assessment on treating physicians' management plans and to assess the feasibility of completing the study procedures and delivering assessment reports within the predefined time frame. Secondary and exploratory objectives include evaluating fluid balance, diuretic use, inotropic support, inhaled pulmonary vasodilator use, kidney function, and postoperative clinical outcomes. Exploratory analyses will also examine ultrasound measures of fluid responsiveness in relation to Swan-Ganz IQ measurements and the relationship between right ventricular pressure patterns and venous congestion.

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 599 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.

Dexmedetomidine Medication Records and Delirium After Coronary Artery Bypass Grafting

This retrospective observational study uses de-identified electronic health records from the TriNetX Global Collaborative Network. The procedure eligibility period is 1 January 2010 through 1 July 2025. The primary analysis concerns adults with a recorded qualifying coronary artery bypass grafting (CABG) procedure. Valve-coded procedures are examined in a separately constructed and separately matched exploratory population. The populations may overlap and do not constitute independent replication cohorts. Patients are classified by the presence or absence of a dexmedetomidine medication record on the calendar day before or the day of the index procedure. This definition does not confirm administration, dose or intraday timing. The primary outcome is a qualifying delirium or disorientation code during days 1-30. Nine secondary endpoints concern mortality and selected recorded complications during days 0-30; eight are inferential and the prolonged-ventilation code endpoint is descriptive. An inpatient or observation encounter during days 1-30 is described separately and is not interpreted as readmission. Same-day records cannot establish whether an outcome preceded or followed exposure. No treatment is assigned by the investigators. Analyses use permitted aggregate outputs, without identifiable or row-level participant data. The clinical definitions were revised with knowledge of earlier analyses. CABG primary and F05-only outcomes were first rerun on 5 September 2026 and were seen before a technical amendment permitting automatic propensity-score rematching for each outcome batch and unavoidable comparative calculations accompanying descriptive patient counts. The approved eligibility, exposure and outcome windows, codes, covariates, category boundaries and eight-test multiplicity family were not changed by that technical amendment. Subsequent technical refreshes and their source versions are recorded separately. Neither the original registration nor this amendment is presented as prospective registration of the original analysis.

Hospital-to-Home Transitional Cardiac Rehabilitation After Cardiac Surgery

Cardiac rehabilitation (CR) improves outcomes after cardiac surgery, but is usually delivered on a fixed centre-based schedule that requires repeated daytime hospital attendance. A hybrid model, in which supervised training begins in hospital and then transitions to monitored home-based training, may make the service reachable for more patients without reducing supervision during the early postoperative period. This single-blind randomised controlled trial compared a hospital-to-home transitional (hybrid) CR programme with conventional centre-based CR in adults at low exercise-training risk after cardiac surgery. Participants were allocated 1:1. Control participants attended twice weekly for 8 weeks (16 supervised sessions). Hybrid participants attended twice weekly for 2 weeks (4 supervised sessions), underwent a repeat risk assessment, and then trained at home for 6 weeks with heart-rate monitoring, a cloud-based care platform, weekly telephone contact and twice-weekly text messages. The primary outcome was peak oxygen uptake measured by cardiopulmonary exercise testing at baseline and 8 weeks. The trial was designed as a pilot study to estimate treatment effect and variability for a future definitive trial.

Electroacupuncture at ST36 for Reducing Postoperative Inflammation After Cardiac Surgery With Cardiopulmonary Bypass

Cardiac surgery using cardiopulmonary bypass can trigger a marked systemic inflammatory response and may contribute to postoperative organ dysfunction and delayed recovery. Electroacupuncture at the Zusanli acupoint (ST36) may regulate inflammatory responses, but its clinical effects in patients undergoing cardiac surgery remain uncertain. This prospective, randomized, parallel-group study will enroll 140 adults undergoing elective cardiac surgery with cardiopulmonary bypass. After surgery and admission to the intensive care unit, participants will be randomly assigned in a 1:1 ratio to receive either bilateral ST36 electroacupuncture or a control procedure involving the same acupoint localization, skin disinfection, needle insertion, and needle retention without electrical stimulation. Both groups will receive standard postoperative care. The intervention will be administered twice for 30 minutes per session. The primary outcomes are C-reactive protein levels and Sequential Organ Failure Assessment scores on postoperative day 2. Secondary outcomes include the duration of vasoactive drug use, incidence and severity of systemic inflammatory response syndrome, duration of mechanical ventilation, length of intensive care unit and hospital stay, and perioperative inflammatory markers. The study will evaluate whether ST36 electroacupuncture can reduce postoperative inflammation and organ injury and improve recovery after cardiac surgery.

Selective Antegrade Cerebral Perfusion and Perioperative Optic Nerve Sheath Diameter in Ascending Aortic Surgery

In ascending aortic surgery the distal anastomosis may be constructed with the aortic cross-clamp maintained, or, where the extent of the aortic pathology and the geometry of the graft require it, after release of the cross-clamp during a period of systemic circulatory arrest. Both are established surgical approaches. Where the cross-clamp is released, selective antegrade cerebral perfusion (SACP) is an established cerebral protection technique and is applied for that purpose. Where release of the cross-clamp is not required, systemic circulatory arrest is avoided and SACP is not applied. Optic nerve sheath diameter (ONSD) measured by ocular ultrasonography is a non-invasive marker of raised intracranial pressure. Cardiopulmonary bypass may increase blood-brain barrier permeability through hypoperfusion, non-pulsatile flow, hemodilution and systemic inflammation, predisposing to cerebral edema. Perioperative increases in ONSD have been reported after open heart surgery and have been associated with postoperative delirium. Data on how SACP influences perioperative ONSD dynamics in ascending aortic surgery, and whether such changes relate to postoperative delirium, are limited.

Erector Spinae Oxygen Saturation and AKI After OPCAB

Acute kidney injury (AKI) is a frequent and serious complication after cardiac surgery, including off-pump coronary artery bypass (OPCAB). Because AKI is diagnosed on the basis of serum creatinine, which rises 1 to 2 days after the actual renal insult, early detection and timely intervention remain difficult. Near-infrared spectroscopy (NIRS) allows non-invasive and continuous measurement of regional tissue oxygen saturation, but the effective penetration depth of commercially available devices is only approximately 2 to 2.5 cm. In most adults the renal cortex lies deeper than this, so the signal obtained from a flank sensor may originate largely from the abdominal wall musculature rather than from renal parenchyma. This limitation may explain the inconsistent association between renal regional oxygen saturation (renal rSO2) and AKI reported so far. The erector spinae muscle at the level of the renal hilum lies within 2 cm of the skin in most patients and is supplied by the lumbar arteries and by vessels adjacent to the renal hilum. Erector spinae muscle regional oxygen saturation (ESrSO2) may therefore provide a technically more reliable NIRS signal that reflects perfusion of a vascular territory close to that of the kidney, particularly during the transient low cardiac output state induced by mechanical displacement of the heart for coronary anastomosis during OPCAB. This single-center prospective observational cohort study will enroll 138 adult patients scheduled for elective OPCAB at Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea. ESrSO2 and renal rSO2 will be measured continuously with an INVOS oximeter from before anesthetic induction until the end of surgery, in addition to cerebral rSO2, which is part of standard care at the participating institution. The ESrSO2 and renal rSO2 channels will be physically masked on the monitor display during surgery, no alarms will be set for these two channels, and their values will not be used for any intraoperative clinical decision. The recorded data will be extracted after surgery using the INVOS Analytics Tool. Apart from placement of the additional NIRS sensors and a brief pre-induction ultrasound measurement of tissue depth, no study-specific procedure, laboratory test, or imaging study will be performed, and all anesthetic, surgical, and postoperative care will follow the standard institutional protocol. The primary objective is to identify which ESrSO2-derived variable best predicts postoperative AKI, defined by the Kidney Disease: Improving Global Outcomes (KDIGO) criteria within 7 days after surgery. The candidate variables are the baseline value, the intraoperative nadir, the area under the threshold (AUT), and the duration under the threshold below absolute values of 60%, 55%, and 50% and below 80% of the baseline value, calculated separately for the period before cardiac displacement and for the cardiac displacement period. Secondary objectives are to assess whether the selected ESrSO2 variable provides independent and incremental predictive information beyond a pre-specified baseline risk model, to compare the predictive performance of ESrSO2 with that of cerebral rSO2 and renal rSO2, and to evaluate the prediction of severe AKI (KDIGO stage 2 to 3) and persistent AKI (lasting 48 hours or longer). If ESrSO2 proves to be a useful early marker of AKI, it could allow real-time, non-invasive identification of patients at high risk during surgery and provide a basis for future trials of renal protective strategies.

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.

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.

rhBNP for Prevention of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI)

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a common and serious perioperative complication, independently associated with prolonged hospitalization, increased mortality, and progression to chronic kidney disease. Despite advances in surgical techniques and postoperative care, no widely accepted pharmacological prevention strategy exists. Recombinant human brain natriuretic peptide (rhBNP) exerts vasodilatory, diuretic, and natriuretic effects, reduces cardiac preload and afterload, and has demonstrated safety and efficacy in treating congestive heart failure. Preliminary studies suggest rhBNP may reduce postoperative serum creatinine, increase urine output, and improve renal outcomes; however, large-scale randomized controlled evidence is lacking. The PROTECT-CS trial is a multicenter, prospective, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of perioperative continuous intravenous rhBNP infusion (0.01 μg/kg/min for 48 ± 2 hours) for prevention of AKI in high-risk patients undergoing cardiac surgery with cardiopulmonary bypass. A total of 694 participants will be enrolled across 7 centers in China.

Artificial Intelligence for Ulinastatin Responder Outcome & Risk Assessment in CPB

This is a multicenter, retrospective, real-world observational study aimed at developing and validating an artificial intelligence-based tool for identifying ulinastatin treatment responders and risk stratification in cardiac surgery patients undergoing cardiopulmonary bypass (CPB). Ulinastatin, a glycoprotein extracted from human urine, has shown potential benefits in reducing postoperative complications and inflammatory responses in cardiac surgery. However, evidence supporting its efficacy and optimal application in specific patient populations remains insufficient. This study will collect clinical data from approximately 4 tertiary cardiac centers in China, including patients who underwent cardiac surgery with CPB. Using machine learning algorithms (such as weighted K-modes clustering and XGBoost), the study aims to: (1) construct a multicenter real-world database for cardiac surgery; (2) identify clinical characteristics associated with ulinastatin treatment response; (3) develop and validate an AI-based risk stratification tool to assist clinical decision-making. This study may provide evidence-based guidance for personalized perioperative anti-inflammatory treatment in cardiac surgery.

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.

LLM-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Cardiac Surgery Patients

This is a single-center, prospective, randomized, open-label, parallel-controlled clinical study to evaluate the effectiveness of a large language model (LLM)-based intelligent health management assistant in the life-cycle health management of patients after cardiac surgery. A total of 500 adult patients who undergo cardiac surgery (including coronary artery bypass grafting, heart valve surgery, great vessel surgery, congenital heart disease correction, and other cardiac procedures) at Beijing Anzhen Hospital will be randomly assigned in a 1:1 ratio to an intervention group or a control group, stratified by age (\<65 vs ≥65 years) and surgery type. The intervention group will use the LLM-based mobile health management application in addition to standard postoperative care, while the control group will receive standard postoperative care alone. The application integrates multimodal clinical data into a personalized health profile and provides surgery-type-specific postoperative management recommendations, medication adherence reminders, complication early warning, and cardiac rehabilitation guidance. The primary outcome is the composite endpoint of major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke, or unplanned cardiovascular reoperation/reintervention, within 12 months after randomization. Secondary outcomes include health-related quality of life (EQ-5D-5L), cardiovascular rehospitalization rate, medication adherence (MMAS-8), postoperative complication rate, and cardiac rehabilitation achievement rate. Follow-up visits are scheduled at 1, 3, 6, 9, and 12 months post-randomization.

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.