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NCT05885230
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 .
NCT07168421
Limiting perioperative tachycardia (aiming for a heart rate \<90 beats per minute throughout the perioperative period) using the ultra-short acting beta-blocker landiolol in patients with cardiovascular risk factors undergoing major surgery might lower the incidence of perioperative myocardial injury. Feasibility of the intervention needs to be proven prior to conduction of a larger trial.
NCT06772025
Researchers are looking for a better way to treat and prevent cardiac surgery-associated acute kidney injury (CSA-AKI) in people who undergo heart surgeries. CSA-AKI is a common complication in people undergoing heart surgeries, where the kidneys stop working properly. CSA-AKI risk factors include older age and alongside diseases such as kidney disease and diabetes. Longer time with heart-lung machine during heart surgeries also increases the occurrence of CSA-AKI. In this study, researchers want to better understand how CSA-AKI develops (also known as the mechanisms involved in the development of CSA-AKI) in people under heart surgeries, the presence of certain biomarkers in the body, especially with a focus on the early hours and days after the surgery. (A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.) These biomarkers will be compared in participants who develop CSA-AKI within a week after heart surgery with the participants who do not develop CSA-AKI. The relationship with biomarkers will be determined by examining participants' blood and urine samples before and after surgery. This may help researchers better understand CSA-AKI, identify potential treatment targets and develop possible treatments to prevent CSA-AKI. Participants in this study will be people who have heart surgery already scheduled by their own doctors and have a risk of developing CSA-AKI. Participants will not receive any treatment as part of this study. They will undergo the heart surgery and related medical processes as per their normal medical treatment and management. Each participant will be in the study for up to 2 months. During the study, the doctors and their study team will: * collect participants' blood and urine samples before and after surgery * assess participants' medical records and test reports during hospitalization * monitor overall health of the participants throughout the study
NCT07536633
Background: The inflammatory response following cardiac surgery is known to contribute significantly to morbidity and mortality. Neutrophils and inflammatory mediators play a critical role in the pathogenesis of postoperative complications. The aim of this study was to evaluate the effect of intraoperative ketamine administration on the inflammatory response in patients undergoing cardiac surgery using routinely employed immuno-inflammatory parameters in clinical practice. Methods: After randomization, patients were divided into two groups: the ketamine group and the control group. Following admission to the operating room, standard monitoring and anesthesia induction were performed. In addition to the control group, patients in the ketamine group received 1 mg/kg ketamine during induction and a continuous intravenous infusion of 2.4 mg/kg/h ketamine for maintenance. Immuno-inflammatory parameters were assessed using routine blood tests obtained preoperatively and on postoperative day 1. These parameters included leukocyte, neutrophil, lymphocyte, and platelet counts; neutrophil-to-lymphocyte ratio (NLR); platelet-to-lymphocyte ratio (PLR); NLR index; delta NLR; ΔPLR; PLR index; systemic inflammatory response index (SIRI); systemic immune-inflammation index (SII); and C-reactive protein (CRP), ΔCRP, and CRP index. In addition, patients' pain scores within the first 24 hours following postoperative extubation, as well as hospital mortality and morbidity rates, were evaluated.
NCT07523334
Esketamine is frequently used during the perioperative period for supplemental analgesia. Small sample size trials showed that subanesthetic dose esketamine may decrease postoperative neurocognitive complications. However, conflicting results exist and optimal dose of esketamine remains to be determined. This dose-exploring pilot trial is designed to evaluate the safety and efficacy of three different perioperative esketamine dosing regimens in older patients undergoing major non-cardiac surgery. The primary purpose is to explore the optimal dosing strategy that produce maximal neurocognitive benefits with minimal adverse neuropsychiatric symptoms.
NCT06968936
This is a sub-study of the Preoperative Combined Iron Therapy trail in which some participants will be additionally randomized to combined iron supplementation or standarded treatment control to evaluate the impact on long-term outcomes.
NCT07518524
Fast-track cardiac anesthesia (FTCA) has gained significant popularity over the past decades due to its potential to reduce healthcare costs and optimize the use of medical resources. This approach has led anesthesiologists to reconsider the traditional model of cardiac anesthesia, known as Conventional Cardiac Anesthesia (CCA), which historically relied on the administration of high-dose opioids to ensure adequate hemodynamic stability and prolonged postoperative analgesia, thereby reducing the incidence of myocardial ischemia. One of the primary goals of fast-track cardiac anesthesia is early tracheal extubation. Increasing evidence demonstrates that early extubation is associated with a reduction in the length of stay in the intensive care unit (ICU) and overall hospital length of stay, resulting in significant cost savings without negatively affecting patients' clinical outcomes. In contrast, prolonged mechanical ventilation has been shown to have a substantial economic impact and, more importantly, is associated with higher in-hospital mortality and reduced long-term survival, including decreased five-year survival rates. The Ultra Fast Track protocol, which involves extubation directly in the operating room, is currently less commonly used. However, it may further reduce postoperative mechanical ventilation time and the incidence of pulmonary complications, potentially leading to an additional reduction in hospital length of stay. The aim of this study is to compare the Fast Track and Ultra Fast Track protocols in order to evaluate differences in the incidence of respiratory, cardiac, renal, septic, and neurological complications. Postoperative pain will also be assessed using the Numeric Rating Scale (NRS), as well as the incidence of postoperative nausea and vomiting (PONV).
NCT07513974
The study aims to test the relationship between the preoperative pain threshold and the intraoperative need for opioids. The objective of the study is to try to predict a patient's analgesic needs based on their objectively determined preoperative pain threshold. The investigators will include patients scheduled for elective cardiovascular surgery. The investigators will investigate the correlation between the preoperative pain threshold and intraoperative/postoperative opioid consumption in a highly standardized anesthesia setting.
NCT07496424
Myocardial strain analysis provides additional and valuable information about left ventricular function, particularly in the perioperative setting with its dynamic changes in ventricular load conditions. This allows for earlier risk assessment and, if necessary, the initiation of faster and more targeted therapy. Unfortunately, conventional strain analysis using conventional methods currently takes approximately 5 minutes. However, this amount of time is often not available in a dynamically changing intraoperative setting during cardiac surgery. Therefore, the benefits of strain analysis have not yet been routinely utilized during the intraoperative course. However, new software solutions exist that can perform strain analysis fully automatically and reduce the examination time to a few seconds. However, it remains unclear whether these fully automated analyses also function reliably intraoperatively using transesophageal echocardiography (TEE). The aim of this study is to assess the reliability of these new methods.
NCT07484477
This study aims to investigate randomized controlled trial to evaluate whether reducing sedentary behavior improves recovery in post-cardiac surgery patients. Participants are assigned to either a behavioral intervention that substitutes sitting with light activity or to usual care. Changes in exercise capacity and quality of life are the primary measured outcomes. It is hypothesized that the intervention group will demonstrate superior gains in both physical function and well-being. The results could inform a valuable adjunct to existing cardiac rehabilitation programs.
NCT07486167
The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass. Main hypotheses: 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?
NCT06768034
Cardiac complications, particularly myocardial injury after noncardiac surgery (MINS), significantly contribute to 30-day mortality, affecting about 1 in 10 patients after noncardiac surgery. Despite its prevalence and serious implications, there is no consensus on managing myocardial injury after noncardiac surgery in clinical practice. Interventions commonly used for cardiovascular prevention in patients who had a heart attack outside of a surgery context could also be beneficial in patient with MINS. This pilot study trial aims to gather feasibility data, such as recruitment rates and intervention adherence that will guide on the design and inform on sample size of a future study with large pragmatic randomized controlled trial on the impact of systematic referral for secondary cardiovascular prevention on outcomes in patients who had a MINS.
NCT06899971
Patients born with heart defects often undergo surgical procedures on a heart lung machine. With improvements in medical and surgical management, their survival has significantly improved, but their brain insult has not been paid much attention. This study is to determine the relationship between specific proteins in the blood and brain injury in patients less than 18-year-old undergoing heart surgery.
NCT07466082
Acute normovolemic hemodilution (ANH) is a widely used blood conservation strategy in cardiac surgery aimed at reducing intraoperative blood loss and the need for allogeneic blood transfusion. However, inadequate or excessive fluid replacement during ANH may lead to hemodynamic instability and other complications. The Pleth Variability Index (PVI) is a noninvasive dynamic parameter that can predict fluid responsiveness and guide goal-directed fluid therapy during surgery. This study aims to evaluate whether performing ANH under intraoperative PVI guidance in cardiac surgery allows more precise fluid management and reduces allogenic blood transfusion and the risk of perioperative complications.
NCT07410988
This trial aims to compare two intraoperative fluids, namely hydroxyethyl starch (HES) and balanced crystalloids in terms of major adverse kidney events after cardiac surgery. Indications for the study fluids administarion include preload augmentation and intravascular volume replacement during cardiac surgery.
NCT07457879
This retrospective, single-center observational study aims to evaluate the impact of fibrinogen concentrate reimbursement introduced in Belgium in April 1st, 2020, on transfusion practices in complex cardiac surgery. Adult patients undergoing complex cardiac surgery with cardiopulmonary bypass between Jan 1st 2016 and Dec 31st 2024 at Erasme Hospital will be included. Transfusion strategies and clinical outcomes will be compared between the pre-reimbursement and post-reimbursement periods.
NCT06028126
The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy. Participants randomized to the intervention group will receive the blocks with 0.2% ropivacaine administered via catheters placed in the superficial parasternal intercostal plane bilaterally under ultrasound guidance. Researchers will compare this group with a control group given 0.9% saline through similarly placed catheters. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.
NCT07440407
Brief Summary After heart surgery, aerobic exercise is essential for recovery. Traditional exercise planning uses a cardiopulmonary exercise test (CPET), which may be unavailable early after surgery. This study tested a six-minute walk test (6MWT)-based method. Patients aged 30-65 were randomized to either 6MWT-guided or symptom-guided exercise. They completed 14 supervised cycling sessions over two weeks. Safety, exercise progression, training volume, functional capacity, physical performance, and quality of life were measured. Out of 118 patients, 109 completed the program with no serious exercise-related events. The 6MWT group started at higher intensity and achieved greater training volume. Both groups improved similarly in functional and quality-of-life measures, showing the 6MWT method is safe, feasible, and non-inferior to the traditional approach.
NCT07433114
Optimization of postoperative analgesia and reduction of opioid consumption are key components of Enhanced Recovery After Surgery (ERAS) protocols in cardiac surgery. Although intravenous opioids have traditionally been the mainstay of analgesic management due to their potent analgesic effect and hemodynamic stability, high-dose opioid use has been associated with respiratory depression, prolonged mechanical ventilation, delayed extubation, longer intensive care unit stay, and multiple short- and long-term adverse effects. Thoracic wall loco-regional anesthesia techniques represent promising opioid-sparing strategies in minimally invasive cardiac surgery performed via mini-thoracotomy. The purpose of this prospective randomized study is to compare two loco-regional analgesic techniques - the Erector Spinae Plane (ESP) block and the Serratus Anterior Plane (SAP) block - in adult patients undergoing minimally invasive cardiac surgery. The study aims to determine whether one technique is superior in reducing postoperative morphine consumption, improving pain control, and enhancing patient-reported quality of recovery as measured by the Italian Quality of Recovery (iQoR) questionnaire.
NCT07163234
This is a first-in-human, prospective, single-arm, phase I clinical study evaluating the safety of the iPerf femoral arterial cannula in patients undergoing planned cardiac surgery requiring extracorporeal circulation (ECC) via a femoral approach for up to 6 hours. The iPerf device is a dual-lumen arterial cannula designed to provide systemic and lower limb perfusion during ECC, with the goal of reducing the risk of acute limb ischemia. The study will be conducted at a single center in France and will include 15 adult patients. Primary outcomes focus on procedure-related and late adverse events up to 30 days post-surgery. Secondary objectives include assessment of ischemic events, tissue oxygen saturation, and surgeon satisfaction with device handling. The study aims to demonstrate feasibility and safety of the iPerf cannula as an innovative solution for lower limb perfusion during femoral artery cannulation.