Clinical Research Directory

Investigation of the Anti-inflammatory Effect of Ketamine in Cardiac Surgery

Background: Cardiac surgery with cardiopulmonary bypass induces a systemic inflammatory response that may contribute to postoperative complications. Ketamine has been investigated for its potential immunomodulatory effects. This randomised controlled trial evaluated the effects of intraoperative ketamine administration on postoperative inflammatory biomarkers and clinical outcomes in patients undergoing elective cardiac surgery. Methods: This single-centre, randomised, controlled, single-blind trial was conducted at Necmettin Erbakan University Meram Faculty of Medicine Hospital, Türkiye. Between 30 October 2022 and 30 March 2023, 177 patients were assessed for eligibility, of whom 166 provided written informed consent and were randomised to the ketamine (n = 83) or control (n = 83) group. All patients received standard general anaesthesia. In addition, the ketamine group received an intravenous ketamine bolus of 1 mg/kg at induction, followed by a continuous intraoperative infusion of 2.4 mg/kg/h. The two primary outcomes specified in the original study protocol dated 5 September 2022 were neutrophil-to-lymphocyte ratio (NLR) and C-reactive protein (CRP), measured on postoperative day 1. The prespecified secondary outcomes included postoperative pain intensity assessed using the Numeric Rating Scale (NRS) and Prince Henry Hospital Pain Score (PHHPS), time to extubation, intensive care unit length of stay, and hospital length of stay. Additional inflammatory parameters, including platelet-to-lymphocyte ratio (PLR), systemic inflammatory response index (SIRI), systemic immune-inflammation index (SII), and derived measures of perioperative biomarker changes, were evaluated in post hoc exploratory analyses. Additional clinical outcomes, including 28-day all-cause mortality, were also assessed on an exploratory basis. Six randomised patients (three per group) died before postoperative day 1 biomarker measurements could be obtained. Consequently, 160 patients (80 per group) were included in the primary biomarker analyses, while all 166 randomised patients were included in the 28-day mortality analysis. The study was retrospectively registered at ClinicalTrials.gov on 30 March 2026, after completion of recruitment and data collection.

Sarcopenia and Training Outcomes in Post-cardiac Surgery Patients

The goal of this observational study is to assess the prevalence of sarcopenia and see whether the current care is sufficient to improve sarcopenia outcomes in patients after cardiac surgery. The main questions it aims to answer are: How prevalent is sarcopenia after cardiac surgery? Is the current standard of care sufficient to improve sarcopenia outcomes after cardiac surgery? Participants will: * Perform test to assess sarcopenia one day before leaving the hospital * Perform these tests again after 4 weeks, 16 weeks, and/or 1 year depending on their sarcopenia status at baseline and whether or not they will follow a cardiac rehabilitation program

Randomized Evaluation of Operating Room Extubation After Cardiac Surgery

We are studying whether waking patients up and removing the breathing tube (also known as "extubation") in the operating room after cardiac surgery improves postoperative recovery without causing harm.

The Impact of Multiple Antihypertensive Therapy on Post-Induction Hypotension Burden in Cardiac Surgery Patients

This study aims to investigate the impact of multiple preoperative antihyperstensive drug use on the burden of post-induction hypotension (PIH) in patients undergoing elective cardiac surgery. The researchers will observe whether the combination of different antihypertensive classes (such as ACE inhibitors, ARBs, beta-blockers, and calcium channel blockers) leads to a higher incidence and severity of blood pressure drops and increased need for vasoactive support during the period between anesthesia induction and surgical incision.

Effect of Stellate Ganglion Block on Arterial Catheterization Complications in Selected Group of Patients Undergoing Elective Cardiac Surgeries

Radial artery catheterization is the usual method for invasive monitoring in cardiac surgeries. Although it is relatively safe, complications do happen. Hematoma and ischemia are well known complications. Also, radial-to-femoral arterial pressure gradient (RFAPG) post bypass is a common event which affect management of a critical patient in a critical time. the study examines the effect of left stellate ganglion block (LSGB) on decreasing radial artery complications in cardiac surgeries

Oral Methadone in Cardiac Surgery

The purpose of this study is to compare the effects of administration of oral methadone preoperatively and intravenous methadone upon induction of general anesthesia on postoperative pain for patients undergoing elective cardiac surgery.

Respiratory Physiotherapy and PMR After Cardiac Surgery

This study aims to evaluate the effects of respiratory physiotherapy combined with progressive muscle relaxation exercises on dyspnea, anxiety, hemodynamic status, and delirium symptoms in patients after cardiac surgery. This randomized controlled trial will include 116 patients who will be randomly assigned to an intervention group or a control group. The intervention group will receive respiratory physiotherapy and progressive muscle relaxation exercises in addition to routine postoperative care for 30 minutes per day over eleven days, while the control group will receive routine care only. Outcome measures will include dyspnea assessed by the Modified Borg Scale, anxiety assessed by the State-Trait Anxiety Inventory, hemodynamic parameters obtained from vital signs, and delirium symptoms assessed using the Nursing Delirium Screening Scale. It is hypothesized that the combined intervention will reduce dyspnea and anxiety levels, improve hemodynamic stability, and decrease delirium symptoms. The findings are expected to contribute to improved postoperative recovery and reduced complication risks following cardiac surgery.

Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery

Primary objective: to evaluate the non-inferiority in terms of improvement of hemoglobin (Hg) levels within 30 days postoperatively between two proposed treatments. Secondary objective: to evaluate the financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV), while demonstrating non-inferiority in the improvement of hemoglobin levels, reduction in transfusion requirements, and reduction of hospital/ICU stay length

Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)

This is a multi-institutional study (CCF, UPMC, OSU) evaluating different ventilation strategies during cardiopulmonary bypass on mortality and postoperative pulmonary complications, with sub-study investigating 8-iso-prostaglandin F2a and sRAGE levels.

Perioperative Nitric Oxide Prevents Acute Kidney Injury in Cardiac Surgery Patients With Chronic Kidney Disease

The protective nitric oxide (NO) effects are mediated by selective pulmonary vasodilation and improvement of arterial oxygenation in hypoxemic patients by reducing intrapulmonary shunting and improving ventilation-perfusion coordination. Inhaled NO has been used for years to treat acute respiratory failure and pulmonary hypertension in anesthesia and intensive care. The nephroprotective role of NO was studied in an experimental model of contrast-induced nephropathy. The primary aim of this prospective, double-blind, randomized, parallel-group, controlled trial is to test the hypothesis that perioperative conditioning of patients with NO at a dose of 80 ppm, obtained by plasma-chemical synthesis technology, through a ventilator and an extracorporeal circulation circuit reduces the incidence of acute kidney injury (AKI) in patients with an initially high risk of kidney damage due to the presence of preoperative chronic kidney disease (CKD). The study is interventional. Examination and treatment of patients is carried out in accordance with the approved standards of medical care for the relevant diseases. During the study, no experimental or unregistered (not approved for use) medical or diagnostic procedures in the territory of the Russian Federation will be carried out. The study includes patients admitted to the Cardiac Surgery Department of Cardiology Research Institute of Tomsk NRMC for elective surgery with high risk of AKI in the perioperative period

Ultrasound Mapping of the Anatomical Relationship Between the Right Internal Jugular Vein and Carotid Artery

This prospective observational study will describe the anatomical relationship between two major blood vessels on the right side of the neck: the internal jugular vein and the common carotid artery. These vessels lie close together, and their relative positions are relevant when placing a central venous catheter. The study will enroll 200 adults undergoing elective cardiac surgery at Ankara Bilkent City Hospital who require right internal jugular vein catheterization as part of their routine care. A single ultrasound image will be recorded for each participant under standardized conditions after general anesthesia and before catheter placement. Computer-assisted image analysis will determine the angular position of the artery around the center of the vein on a 0°-360° scale. The study will describe the distribution of these angles and their frequencies within eight anatomical sectors. The findings may provide a more detailed quantitative description of neck vascular anatomy and support future research on ultrasound-guided central venous access. Participation will not alter routine anesthesia or catheterization management.

Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy

Rationale Cardiac surgery via median sternotomy carries an elevated risk of postoperative complications and delayed functional recovery. Preoperative physical therapy aims to reduce the incidence and severity of postoperative adverse outcomes and to accelerate functional recovery. However, current evidence on prehabilitation is inconsistent due to methodological heterogeneity. This study addresses the limitations of previous studies in four ways. First, a validated preoperative prediction model is used to select patients at high risk of in-hospital postoperative complications and delayed functional recovery. Second, a Cardiopulmonary Exercise Test (CPET) is performed at baseline to guide safe and effective intensity prescription. Third, as different patient populations are expected to benefit from different training programs, the prehabilitation program is tailored to the surgical indication: patients undergoing coronary artery bypass grafting (CABG) receive high-intensity interval training (HIIT), and patients undergoing aortic valve replacement (AVR) receive moderate continuous training. Fourth, physical activity and self-management are promoted by using a wearable physical activity monitor and Shared Decision-Making (SDM) to stimulate and track daily physical activity. Primary Objective To investigate the feasibility of a personalized, procedure-specific prehabilitation program (four to six weeks) for high-risk patients scheduled for elective cardiac surgery via sternotomy, with respect to recruitment, adherence, drop-out, safety, and acceptance. The program consists of two physiotherapist-supervised group training sessions per week, promotion of physical activity, and unsupervised home-based exercise. Secondary Objective To provide a preliminary evaluation of participant responses to the intervention, focusing on changes in cardiorespiratory fitness (WRpeak), peripheral muscle strength (1RM), inspiratory muscle strength (MIP), physical activity (time spent active per day), and health-related quality of life (SF-36). Study design A prospective, single-center, longitudinal, mixed-methods pilot study conducted at Maastricht University Medical Center (MUMC+). Study population High-risk patients (n=24), defined by EuroSCORE II, who are scheduled for elective cardiac surgery via sternotomy (CABG or AVR). Main study parameters/endpoints The primary endpoint is the feasibility of the prehabilitation intervention with respect to recruitment, adherence, drop-out, safety, and acceptance. Burden Participation involves a structured time commitment with clinic and home components. Total supervised clinic time is estimated at 11-15 hours, covering two baseline assessments, 8-12 training sessions, and the final evaluation and interview. Total time at home is estimated at 16.5-19 hours, covering daily diary completion and unsupervised home exercises. These ranges depend on the patient's time to surgery. Risks and mitigation The risk of acute cardiac events during exercise is elevated in this high-risk population. This risk is mitigated by strict adherence to NVVC/MUMC+ absolute stop criteria, continuous medical supervision during all testing and training sessions, and individualized intensity prescription based on CPET. The risk is considered acceptable in relation to the scientific value of studying this specific high-risk cohort, which makes the study group-related. Benefit and group relatedness Direct clinical benefit cannot be guaranteed, as this is a feasibility study. However, patients receive an intensive, personalized prehabilitation program that is designed to reduce the incidence and severity of postoperative adverse outcomes.

Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine

Right ventricular failure (RVF) is a common complication to cardiac surgery, which is associated to mortality, kidney failure, stroke, prolonged mechanical ventilation and ICU stay. The right ventricle is particularly vulnerable to an increased afterload. By increasing pulmonary vascular resistance (PVR), atelectasis might mitigate a negative effect on the right ventricle. Recruitment maneuvers have been shown to resolve atelectasis and improve hemodynamics by increasing cardiac output and lowering PVR. However these maneuvers transiently raise airway pressures, which in turn increases right ventricular afterload, a situation often poorly tolerated by patients with RVF. Prone position is used in patients with respiratory failure and has been shown to decrease mortality in patients with ARDS. Prone position decreases atelectasis and moves ventilation dorsally. In ARDS it also seems to mediate beneficial hemodynamic effects such as an increase in cardiac output and a decrease in PVR. The investigators hypothesis is that prone position early after cardiac surgery will increase cardiac output by recruitment of atelectasis and thereby decrease PVR.

SPIP vs ESP Block in Cardiac Surgery

This multicentre, randomized, assessor-blinded, non-inferiority trial will compare the analgesic efficacy of bilateral superficial parasternal intercostal plane (SPIP) block with bilateral erector spinae plane (ESP) block in adults undergoing first-time on-pump cardiac surgery through median sternotomy. Participants will be randomly assigned in a 1:1 ratio to receive either SPIP or ESP block before induction of general anesthesia, in addition to standardized perioperative multimodal analgesia. The primary outcome is cumulative intravenous morphine milligram equivalent (IV-MME) consumption from extubation to 24 hours after extubation. The study will evaluate whether SPIP block is non-inferior to ESP block using a prespecified non-inferiority margin of 3 mg IV-MME.

Frailty and Ultrasound-Guided Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients

This prospective observational study aims to evaluate the association between preoperative frailty and the procedural difficulty of ultrasound-guided internal jugular vein catheterization in adult patients undergoing elective cardiac surgery. Frailty will be assessed using the Clinical Frailty Scale and handgrip strength measurements. Preprocedural ultrasound evaluation will include internal jugular vein anatomical characteristics such as anteroposterior and transverse vein diameters, cross-sectional area (CSA), common carotid artery diameter, skin-to-vein distance, overlap status, and sternocleidomastoid muscle thickness Catheterization difficulty will be assessed using the Gaber Procedural Difficulty Index. The study seeks to determine whether frailty and ultrasound-derived anatomical parameters can predict difficult internal jugular venous catheterization and improve preprocedural risk assessment without altering routine clinical care.

Ketamine and Kidney Injury in Cardiac Surgery

The purpose of this study is to investigate the affects of ketamine use for anesthesia at the beginning of heart surgery on kidneys compared to the use of propofol.

Validation and Feasibility of Noninvasive Oxygen Delivery Index Monitoring in Cardiac Surgery Patients

This study will establish the feasibility and preliminary validity of real-time oxygen delivery index (DO₂i) monitoring using noninvasive hemoglobin (SpHb, Masimo) and minimally invasive cardiac output (FloTrac, Edwards) in cardiac surgery patients.

Calcium Administration in Cardiac Surgery

Termination of cardiopulmonary bypass is a critical step in any cardiac surgical procedure and requires a thorough planning. Debate about rationale of calcium administration during weaning of cardiopulmonary bypass has been conducted for several decades; however, a consensus has not been yet reached. Perioperative hypocalcemia can develop because of haemodilution or calcium binding from heparin, albumin and citrate. Perioperative hypocalcemia is often complicated by development of arrhythmias, especially QT interval prolongation. Furthermore, low content of calcium can lead to vascular tone disorders, violation of neuromuscular transmission, altered hemostasis and heart failure, resistant to inotropic agents, especially in patients with concomitant cardiomyopathy. On the other hand, hypercalcaemia is a dangerous complication in cardiac surgery. Among the fatal, but rather rare complications, there are acute pancreatitis and the phenomenon of the "stone heart", which is essentially a reperfusion injury of the myocardium caused by rapid calcium overload. Hypercalcaemia can also trigger rhythm disturbances, hypertension, increase systemic vascular resistance, reduce diastolic compliance and impair relaxation of the myocardium due to excessive calcium intake into the cardiomyocytes, cause coronary vasospasm and aggravate ischaemic myocardial damage, impair arterial graft blood flow during aortocoronary and mammary coronary bypass surgery. To date, there is a lack of data indicating clinical efficacy of calcium administration before separation from CPB. Therefore, we designed this randomized controlled trial to test the hypothesis whether calcium administration at termination of CPB will reduce the need for inotropic support at the end of surgery.

Impact of Preoperative Mild Cognitive Impairment on Postoperative Delirium in Patients Undergoing Cardiac Surgery

This study is intended to explore the impact of mild cognitive impairment on the incidence of delirium after cardiac surgery in older patients. The main question this study tries to answer is: Does preoperative mild cognitive impairment influence the incidence of postoperative delirium in cardiovascular surgery? Participants diagnosed with mild cognitive impairment who are supposed to perform cardiovascular surgery will answer questionnaires about cognitive function after surgery.

Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair

The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary bypass. The primary hypothesis is that optimizing end-expiratory lung volume through a standardized PEEP titration maneuver improves cardiac performance and lung function. Secondary objectives are to evaluate whether this strategy reduces duration of mechanical ventilation, improves hemodynamics and ventilation-perfusion matching, and decreases the need for vasopressor support.

Planned Operating-Room Extubation After Cardiac Surgery

The goal of this clinical trial is to learn whether removing the breathing tube in the operating room after cardiac surgery helps adults recover faster than removing the breathing tube later in the intensive care unit (ICU), without increasing the risk of complications. The main questions it aims to answer are: * Does planned operating-room extubation increase the amount of time patients are alive and free from breathing-machine support and significant blood-pressure or heart-support medications during the first 72 hours after surgery? * Is planned operating-room extubation as safe as standard early ICU extubation with respect to important complications such as death, stroke, reoperation for bleeding, breathing failure requiring additional support or reintubation, and unplanned ICU readmission? Researchers will compare planned operating-room extubation with standard enhanced-recovery care in which patients remain intubated when leaving the operating room and are extubated in the ICU, with a target of within 6 hours after surgery when clinically appropriate. Participants will: * Provide informed consent before surgery * Be randomly assigned to one of the two extubation strategies * Receive otherwise standard cardiac surgical, anesthesia, and ICU care * Have routine clinical information collected during the first 72 hours after surgery and through hospital discharge * Complete a short questionnaire about their recovery on postoperative day 2 * Have their health status followed to 30 days after surgery If a participant assigned to operating-room extubation develops a clinical concern that makes immediate extubation unsafe, the treating team may keep the breathing tube in place and transfer the participant to the ICU while continuing standard care.

Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children

The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in 1. study) children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass and 2. study) in children with severe respiratory failure at risk for or need for ECMO. The main questions it aims to answer are: Main hypotheses of CHD study: Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve: * cardiac performance * lung function Does it make a difference in: * length of ventilation * ventilation/perfusion mismatch of the lung * need for vasopressor support? Main hypotheses of ECMO study: Does a LVOM in children/infants with severe respiratory failure /ARDS * improve lung compliance and gas exchange * facilitate lung protective ventilation according to PALICC-2 guidelines * improve lung aeration and V/Q-matching assessed with EIT Does it make a difference in * need for ECMO * duration of ECMO runs * hemodynamics stability

Efficacy of Ultrasound Guided PIFB Versus Lidocaine Infusion on Postoperative Pain After Sternotomy

Chronic pain is a common complication after cardiothoracic surgery. The prevalence of post-sternoyomy pain syndrome (PSPS) ranges from 33% to 91%. Exact pathogenetic mechanisms for developing chronic pain after sternotomy are unknown. Apart from intraoperative nerve damage and subsequent postoperative neuropathic pain, operation techniques, age, sex, pre-existing pain, genetic and psychosocial factors, severe postoperative pain, and analgesic management are suspected to have an impact on the development of PSPS .

Autologous Cold-stored Apheresis Platelets

The Auto-PLTS Study is a single-centre trial performed at Toronto General Hospital (TGH) that uses a randomized, patient preference design. The recent introduction of cold-stored platelets with a shelf-life of 14 days into clinical practice has made it possible to offer autologous apheresis platelet predonation to patients undergoing elective cardiac (and other high-blood-loss) surgeries while allowing sufficient time to recover platelet count before surgery. The Auto-PLTS Study is designed to assess whether replacing allogeneic platelets with autologous platelets will improve patient outcomes and benefit the healthcare system by reducing the burden on allogeneic platelet supply. The study is also designed to determine whether patients are willing to donate autologous platelets 7-10 days prior to surgery.