Clinical Research Directory

Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery

Prophylactic effect of nirmatrelvir/ritonavir and ursodeoxycholic acid on reducing complications after cardiac surgery during covid-19 pandemics (the pep trial) is a multicenter, randomized controlled trial. The aim of the pep trial is to investigate whether prophylactic use of nirmatrelvir/ritonavir and ursodeoxycholic could reduce complications after cardiac surgery.

Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Cardiac Surgery

This prospective, randomized, controlled study aims to evaluate the effects of ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block on postoperative recovery and pain management in patients undergoing cardiac surgery. A total of 50 adult patients will be randomized into two groups: an SPSIP block group and a control group. The investigators will assess postoperative pain, opioid consumption, and quality of recovery during the postoperative period.

The Effects of Dexmedetomidine on Postoperative Cognitive Function in Open Heart Surgery

To assess the impact of Dexmedetomidine on postoperative cognitive function and serum Neuron Specific Enolase levels as an indicator of neuronal injury in patients undergoing open heart surgery

ERAS Compliance and Nutritional Outcomes After Open Heart Surgery

This prospective observational cohort study will evaluate the association between compliance with an Enhanced Recovery After Surgery (ERAS) protocol and postoperative nutritional and clinical outcomes in adult patients undergoing elective open heart surgery through median sternotomy. No research-specific treatment or intervention will be assigned. Compliance with preoperative, intraoperative, and postoperative ERAS components will be recorded for each participant. An overall ERAS compliance percentage will be calculated, and participants will be classified as having high (≥80%), moderate (60-79%), or low (\<60%) compliance. Nutritional status will be assessed using the Nutritional Risk Screening 2002 (NRS-2002) score and the Prognostic Nutritional Index (PNI) before surgery and 48 hours after surgery. Frailty will be assessed preoperatively using the Clinical Frailty Scale, and surgical risk will be estimated using EuroSCORE II. Postoperative complications, intensive care unit and hospital length of stay, and readmission within 30 days will also be recorded.

Cardiopulmonary Bypass Induced Red Blood Cell Lysis

Studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury, limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB.

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.

Nociception Monitoring During Cardiac Surgery

Cardiac surgery is frequently a source of acute or chronic pain. According to the International Association for the Study of Pain (IASP), nociception is defined as "the neural mechanisms of encoding and processing harmful stimuli," while pain is defined as "an undesirable sensory and emotional experience associated with real tissue damage". When patients are under general anesthesia (GA) during surgery, a lack of intraoperative analgesia can expose them to high levels of pain sensitization associated with surgical nociceptive stimuli. The response to the surgical nociceptive stress (via activation of the autonomic nervous system) can lead to alterations in hemodynamic or metabolic status, coagulation or the immune system. In addition, it is now well established that acute intra- and post-operative pain is directly related to the onset of chronic pain, particularly in the post-sternotomy period. On the contrary, excessive administration of opioid analgesics causes moderate to severe side effects (nausea, vomiting, bradypnea, delayed awakening, prolongation of recovery time, hyperalgesia syndrome, postoperative tolerance to opioids leading to misuse or occurrence of DCPO), which will result in postoperative morbidity for the patient independent of the surgery. Indeed, in cardiac surgery, there is a dose-dependent relationship between the intraoperative use of opioid analgesics such as remifentanil and the occurrence of postoperative hyperalgesia. The interest in intraoperative monitoring of nociception has therefore clearly increased in order to improve patient care from the point of view of intra- and postoperative pain management: administering a sufficient and personalized dose of analgesics, neither too high nor too low. Strategies to prevent perioperative pain must therefore be developed to avoid sensitizing the patient to pain and thus limiting the onset of CD, or conversely, to avoid the onset of side effects from excessive analgesic treatment. These strategies include intra-operative pain monitoring. Numerous medical devices are available on the market to measure the level of nociception in patients undergoing GA. The vast majority of these monitors analyse clinical parameters that assess the balance between the sympathetic and parasympathetic nervous systems. Of all the monitors available, there is currently only one multiparametric monitor, the PMD200® which provides the Nociception Level Index or NOL Index (Medasense, Ramat Gan, Israel). In fact, the latter incorporates 5 parameters in its assessment of nociception: heart rate, RR segment variability, pulse wave amplitude, skin conductance level and skin temperature with the number of variations of these last two parameters. New devices for monitoring nociception used in the administration of intraoperative intravenous opioid agents could help to adjust the analgesia/nociception balance. In non-cardiac surgery, the NOL index has shown better sensitivity and specificity than variations in heart rate and blood pressure in detecting and helping to manage a surgical nociceptive stimulus during GA. This monitor has also enabled a dramatic reduction in the doses of intraoperative opioids administered. In this study we hypothesized that monitoring of nociception using the NOL index is feasible during coronary artery surgery despite extracorporeal circulation.

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.

Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery

SGLT-2 inhibitors are recommended treatments for managing heart failure patients. In cases of surgery, it is recommended to stop the treatment 3 days before surgery due to the risk of postoperative euglycemic diabetic ketoacidosis. However, several data suggest that it may be beneficial to maintain SGLT-2i treatment given the possibility of improving postoperative cardiovascular outcomes. Investigator team wish to conduct a randomized controlled trial to test the hypothesis that preoperative maintenance of SGLT-2i is superior to discontinuing them 3 days before surgery in improving postoperative cardiovascular outcomes.

Frailty and Dependency in Older Adults Undergoing Cardiac Surgery

Frailty and dependency are common conditions among older adults undergoing cardiac surgery and may adversely affect postoperative recovery and readiness for hospital discharge. Early identification of these conditions before surgery may facilitate individualized perioperative care and improve postoperative outcomes. This observational study aims to investigate the effects of preoperative frailty and dependency on postoperative recovery and readiness for hospital discharge in older patients undergoing cardiac surgery. Data will be collected before surgery and at hospital discharge using validated assessment instruments. The findings are expected to support preoperative risk assessment and contribute to individualized nursing care planning for older cardiac surgery patients.

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.

Evaluation of Preoperative Anxiety Level Based on the Day of Admission for Cardiac Surgery

Prospective, observational, non-randomized study that evaluates the impact of the admission day (J-1 vs J-0) on preoperative anxiety 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.

Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation After Heart Surgery

This prospective, single-arm study aims to evaluate the effectiveness of Phase I cardiac rehabilitation based on remote electrocardiographic (ECG) monitoring in patients undergoing heart surgery. Eligible participants will receive a comprehensive cardiac rehabilitation program consisting of inpatient and home-based rehabilitation while wearing the MEMO Patch for remote ECG monitoring. Clinical outcomes, including functional exercise capacity, exercise performance, muscle strength, physical function, and health-related quality of life, will be evaluated before rehabilitation, before hospital discharge, and after completion of the rehabilitation program.

Evaluation of an AI-Based Lightweight ECG Telemetry Monitoring System

This study aims to evaluate the clinical applicability of the AI-based lightweight ECG monitoring system (MEMO Patch Plus) as a telemetry ECG monitoring system in patients undergoing cardiac surgery. Participants will wear the MEMO Patch Plus for at least 48 hours and up to 168 hours after transfer from the intensive care unit to the general ward. The study will evaluate real-time ECG transmission, arrhythmia detection, device usability, and safety to generate preliminary evidence supporting future clinical studies.

Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications

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.

Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery

Intraoperative hemodynamic instability (IOHI) is a common occurrence during cardiac surgery and is associated with organ hypoperfusion. However, the specific impact of IOHI on composite adverse outcomes remains unclear. This prospective cohort study aims to evaluate the association between intraoperative hemodynamic instability (defined as MAP \< 65 mmHg or vasopressor requirement) and major postoperative complications (Delirium, Acute Kidney Injury, Stroke, or Mortality) in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass.

Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery

Acute kidney injury affects more than 30% of patients after cardiac surgery, and is associated with an excess in mortality. There is a clinical continuum between acute kidney injury (transient if \<48h, persistent if \>48h), the development of acute kidney and chronic renal failure. Each of these entities characterising renal recovery is associated with an increase in long-term morbidity and mortality. Fluid management in patients with acute kidney injury is challenging, as both hypovolaemia and hypervolaemia are detrimental. Venous congestion (reflecting intravascular hypervolaemia), is a well-established haemodynamic factor contributing to acute kidney injury after cardiac surgery. An ultrasound score, based on the venous doppler pattern explored in intra-abdominal organs, has recently been developed and is a better predictor of acute kidney injury than central venous pressure. Whether using the VeXUS score to guide fluid removal in haemodynamically stabilised patients could promote renal recovery after acute kidney injury remains to be investigated. Before designing a large randomised trial to test such a strategy, its feasibility in a pilot randomised trial is assessed.

Impact of a Technology Platform Based on Enhanced Recovery After(ERAS) Surgery on Length of Stay After Coronary Artery Bypass Grafting: Timely Project

Cardiovascular diseases continue to be the leading cause of death worldwide. Among them, coronary artery disease has the greatest impact, being characterized as one of the main causes of death in Brazil over the last decade. One of the well-established treatments is coronary artery bypass grafting, which is the most performed among cardiac surgeries and, in our scenario, is primarily funded by the Unified Health System (SUS). The information obtained from the Paulista Registry of Cardiovascular Surgeries (REPLICCAR), in partnership with FAPESP, has been important for implementing improvements in the landscape of cardiac surgeries in the state of São Paulo. Although outcomes in cardiac surgery have improved due to the structuring and organization of quality programs, this is still not a reality at the national level. In a situation where data collection and quality initiatives play a central role in continuous improvement, generating value becomes essential for the sustainability of cardiac surgery programs. In this sense, the concept of Enhanced Recovery After Surgery (ERAS) has gained increasing traction. This concept is based on multidisciplinary protocols and scientific evidence, which help prepare patients for rapid recovery, resulting in reduced complications, shorter hospital stays, and, primarily, lower hospital costs. On the other hand, the increase in surgical waiting lists has also led to a rise in home mortality due to cardiac causes. Thus, among the various challenges imposed by the current scenario, the investigators believe that preparing patients for rapid recovery after coronary artery bypass grafting presents an opportunity for the sustainability of the healthcare system. Therefore, the aim of this project is to evaluate the impact of a technology platform based on ERAS on the postoperative recovery time of patients undergoing coronary artery bypass grafting in reference centers in the state of São Paulo, Timely Project - REPLICCAR III.

Exercise Prehabilitation in Congenital Heart Disease

Around 8-12 in every 1000 babies are born with an abnormal heart, known as a congenital heart defect (CHD). Thanks to major advances in medical and surgical care, most babies born with CHD now live into adulthood. As people with CHD get older, many need repeated heart operations. It is known from other areas of medicine that "prehabilitation" - a short, structured exercise programme completed before surgery - can improve fitness and help patients cope better with major operations. However, this approach has never been tested in adults with CHD. The investigators are running a randomised controlled trial to find out whether a prehabilitation programme can improve physical fitness before heart surgery in adults with CHD. Participants will be randomly assigned to usual care or a prehabilitation group. Those in the prehabilitation group will follow a tailored, supervised exercise plan for several weeks before surgery. All patients undergoing cardiac surgery routinely complete a cardiopulmonary exercise test (CPET) as part of their standard pre-operative assessment. CPET is a well-established test that shows how the heart and lungs respond to increasing levels of exercise. During the test, participants exercise on a bike while their breathing, heart rate, and overall physiological response are continuously monitored. The results of each participant's routine CPET will be used to guide the individualised exercise programme in the intervention group. Exercise levels prescribed in the study will not exceed the intensity already safely achieved during the routine CPET, ensuring that activity remains within clinically assessed limits. Participants in the trial will complete an additional second CPET following the trial period. The key question is whether a tailored exercise programme can improve fitness in adults with CHD before heart surgery, and whether this approach is feasible, acceptable and practical to deliver, including successful recruitment and measurable physiological improvements.

Assessment of a Multimodal Analgesia for Enhanced Recovery After Cardiac Surgery

This work aims to assess the analgesic efficacies of transversus thoracic muscle plane block (TTPB) and transversus thoracic muscle plane block (TTPB) for open cardiac surgeries

Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery

The goal of this clinical trial is to learn if perioperative Transversus Thoracic Plane Block (TTPB) decrease perioperative pain after cardiac surgery. The main questions it aims to answer are: 1. does Transversus Thoracic Plane Block decrease perioperative pain after cardiac surgery more than the standard analgesic treatment? 2. Are the results different if the investigators perform Transversus Thoracic Plane Block before surgery or at the end of surgery?

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.

Delayed Cold-Stored Platelets -PLTS-1

PLTS-1 is a multicentre, randomized, controlled, pilot trial, using a conventional, parallel group, two-armed design at 2 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT to determine the non-inferiority of cold-stored platelets compared to conventional platelets with respect to hemostatic effectiveness (total number of allogeneic blood products transfused within 24 hours after CPB), as well as safety.