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NCT07547020
Hemodynamic instability is a common and serious condition in patients undergoing liver transplantation and is associated with increased morbidity and mortality if not promptly recognized and treated. It results from multiple interacting factors, including blood loss, changes in vascular tone, cardiac dysfunction, and complications related to the surgical procedure. Traditional monitoring strategies focus on global hemodynamic variables such as blood pressure and cardiac output. However, these parameters may not accurately reflect tissue perfusion or oxygen delivery at the microcirculatory level. As a result, patients may appear hemodynamically stable while still experiencing inadequate tissue oxygenation. This study aims to evaluate hemodynamic instability using an integrative physiological approach based on the interaction between different components of the cardiovascular system. Specifically, the study will assess four key interfaces: the relationship between the heart and the arterial system, the coherence between macrocirculation and microcirculation, the interaction between venous return and the right atrium, and the coupling between the right ventricle and the pulmonary circulation. The main objective is to identify distinct hemodynamic profiles in patients during the immediate postoperative period following liver transplantation. In addition, the study will evaluate the incidence of tissue hypoxia within the first 24 hours and its association with clinical outcomes, including 30-day evolution. This is a prospective observational study conducted in adult patients admitted to the intensive care unit after liver transplantation who develop hemodynamic instability requiring vasoactive support. During the first 24 hours, multimodal hemodynamic monitoring will be performed, including assessment of cardiac function, vascular tone, venous congestion, pulmonary circulation, and markers of tissue perfusion such as lactate levels and capillary refill time. By integrating these variables, patients will be classified into different hemodynamic profiles according to the predominant underlying mechanism. This approach aims to improve the understanding of cardiovascular dysfunction in this setting and to support more individualized and physiologically guided management strategies.
NCT06238180
The goal of this prospective observational study is to develop and utilize an Artificial Intelligence (AI) model for the prediction of postoperative sepsis in patients undergoing abdominal surgery. The main questions it aims to answer are: 1. Can a remote AI-driven monitoring system accurately predict sepsis risk in postoperative patients? 2. How effectively can this system integrate and analyze multimodal data for early sepsis detection in the surgical ward? Participants are equipped with non-invasive PPG-based wearable devices to continuously monitor vital signs and collect high-quality clinical data. This data, along with demographic and laboratory information from the Electronic Health Record (EHR) of the hospital, are used for AI model development and validation.
NCT07123675
This proof-of-concept randomized controlled trial evaluates a reinforcement learning (RL)-based clinical decision support system for intraoperative hemodynamic management during non-cardiac surgery. Background: Intraoperative hypotension is common during general anesthesia and is associated with adverse outcomes including acute kidney injury, myocardial injury, and increased mortality. Current hemodynamic management relies on the individual anesthesiologist's clinical judgment, which can vary in consistency and timeliness. An RL-based system that learns optimal vasoactive agent dosing strategies from clinical data may help standardize and improve real-time hemodynamic decision-making. Purpose: The primary objective is to evaluate whether the RL-based decision support system can learn intraoperative hemodynamic management decisions comparable to those of experienced anesthesiologists, as measured by the mean absolute error (MAE) between RL-recommended and clinician-executed vasoactive agent doses. The secondary objective is to assess whether RL-guided management improves clinical hemodynamic outcomes, including the time-weighted average of hypotension and the percentage of time with mean arterial pressure within the target range. Participants: Adult patients (aged 18 to 85 years, ASA I-IV) scheduled for elective non-cardiac surgery under general anesthesia with continuous invasive arterial blood pressure monitoring. Procedures: Participants will be randomly assigned (1:1) to one of two groups. In the RL-guided group, the anesthesiologist will receive real-time vasoactive agent dosing recommendations from the decision support system displayed on a bedside screen; the anesthesiologist retains full clinical autonomy over all final decisions. In the standard care group, the anesthesiologist will manage hemodynamics according to institutional standard practice without input from the system. The patient and the outcomes assessor will be masked to group assignment. Data collection covers the intraoperative period and 30-day postoperative follow-up.
NCT03592290
To monitor the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.
NCT04972526
The general objective of this study is to evaluate the clinical impact and safety of focused, point-of-care transesophageal echocardiography (TEE) used during the evaluation of critically-ill patients in the emergency and intensive care settings. The target population for this study are critically-ill patients over the age of 18 who as part of their routine clinical care are receiving a focused TEE. The primary objective of this study is to determine the clinical impact and safety of TEE performed during the evaluation of critically-ill patients in the emergency department and intensive care settings. The secondary objective(s) of this study are to characterize the use of this imaging modality in the subsets of critically-ill patients in shock and cardiac arrest; including but not limited to; description of the frequency of studies, clinical indications, clinician characteristics, echocardiography findings, timing of studies, procedure-related complications and patient outcomes.
NCT07324694
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.
NCT07304661
Hemodynamic instability remains one of the leading causes of morbidity and mortality among critically ill patients in intensive care units. One major contributor to this instability is intravascular fluid deficit. Although fluid administration is often preferred as an initial intervention, inaccurate estimation of fluid requirements carries significant risks. Inadequate resuscitation may lead to tissue hypoperfusion and organ dysfunction, whereas excessive fluid loading is associated with pulmonary edema, increased intra-abdominal pressure, multi-organ dysfunction, and increased mortality. Consequently, reliable prediction of fluid responsiveness is considered a critical determinant in modern intensive care management. The limited reliability of static parameters in predicting fluid responsiveness and the fact that PPV retains its validity only under specific clinical conditions highlight the need for more effective methods. In recent years, hemodynamic changes assessed during the passive leg raising (PLR) maneuver have gained prominence; particularly, left ventricular outflow tract velocity time integral (LVOT VTI)-based cardiac output measurements have been identified as a strong parameter for predicting fluid responsiveness . Moreover, changes in pulse pressure variation (PPV) during PLR have also been reported as a potential predictor; however, the number of studies prospectively comparing PPV variation and LVOT VTI-based cardiac output change within the same patient population remains limited . Therefore, the proposed study aims to fill this gap in the literature and contribute to fluid management in the intensive care setting. The aim of this study is to compare the performance of PPV variation and LVOT VTI-based cardiac output change after the PLR maneuver in predicting fluid responsiveness among mechanically ventilated critically ill patients, and to determine the diagnostic value of both methods. The findings of the present study are expected to support more reliable decision-making in fluid therapy and provide clinical evidence toward the individualization of fluid management in intensive care practice.
NCT05953129
Jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) may be useful in estimating post spinal hypotension in cesarean section operations. Evaluation on the accuracy and effectiveness of these indices can contribute to the early diagnosis and management of hypotension. The main purpose of this study is to evaluate the effectiveness of shock indices in predicting the possibility of post spinal hypotension in cesarean section operations.
NCT05325307
This randomized controlled study evaluates the effect of acupressure application on the anxiety level patients undergoing cystectomy surgery. The hypothesis of this study is that acupressure reduces anxiety levels and stabilizes hemodynamic parameters.
NCT06071026
Net ultra filtration (NUF) is one of the most important parameters during renal replacement therapy (RRT) whose role is to control fluid balance by water removal. To our knowledge, there are no prospective studies or guidelines about the setting of this parameter. In the NEPTUNE study, we aim to compare the hemodynamic effect of three NUF rates during RRT: 1 ml/kg/h, 2 ml/kg/h and 3 ml/kg/h. The research hypothesis is that one of the three flow rates evaluated induces the fewest hemodynamic instabilities related to RRT, while guaranteeing the best possible fluid balance.
NCT07148323
A prospective, non-randomized single arm study using the HemoSphere Alta Advanced Monitoring Platform and associated devices in adult subjects. Data collected from enrolled study subjects will be used for continual device development purposes.
NCT06263075
Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated. Surgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses. This study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements.
NCT05585853
In this study, between 1 January 2025 - 1 June 2025, who met the inclusion and exclusion criteria, a total of 82 patients who are on the 2nd or 3rd day after the surgery and who are hospitalized in the cardiovascular surgery intensive care clinic will be recruited.
NCT07107724
The goal of this prospective observational study is to analyse change in VO2 and VCO2 measured via a dedicated ventilator after hemodynamic optimization maneuvers in adult patients admitted to the ICU with any sign of shock. The main questions it aims to answer are: 1. Do common maneuvers for hemodynamic optimization (fluid bolus and/or vasopressor administration) have any impact on tissue perfusion in terms of oxygen consumption (VO2) and carbon dioxide production (VCO2) measured by a dedicated ventilator? 2. Are the values measured by exhaled gas comparable to those calculated by the measurement of dissolved veno-arterial gas? Participants enrolled in the study will receive advanced hemodynamic monitoring with MostCare Up (Vygon ®) and their hemodynamic instability will be managed according to most recent guidelines and based on clinical decision of treating physicians.
NCT05893420
In this study, the investigators will deploy a software-based clinical decision support tool (eCARTv5) into the electronic health record (EHR) workflow of multiple hospital wards. eCART's algorithm is designed to analyze real-time EHR data, such as vitals and laboratory results, to identify which patients are at increased risk for clinical deterioration. The algorithm specifically predicts imminent death or the need for intensive care unit (ICU) transfer. Within the eCART interface, clinical teams are then directed toward standardized guidance to determine next steps in care for elevated-risk patients. The investigators hypothesize that implementing such a tool will be associated with a decrease in ventilator utilization, length of stay, and mortality for high-risk hospitalized adults.
NCT07064408
This retrospective study evaluated the effects of a subanesthetic dose of esketamine (0.25 mg/kg) on intraoperative hemodynamic stability and postoperative recovery quality in elderly patients (aged 65-75) undergoing thoracic surgery under general anesthesia. A total of 230 patients were included and randomly assigned to receive either esketamine or placebo during anesthesia induction. Key outcomes included blood pressure and heart rate stability, catecholamine levels, recovery time, incidence of adverse events such as delirium or nausea, and opioid use.
NCT07054151
This observational study aims to determine the correlation between capillary refill time (CRT) and vital parameters in patients presenting to the emergency department. It explores whether CRT is associated with triage categories and vital signs in non-traumatic patients, including oxygen saturation (SpO₂), heart rate, systolic and diastolic blood pressure, body temperature, forearm temperature, and respiratory rate. Patients admitted to the emergency department of a training and research hospital were assigned triage codes (green, yellow, red). Their CRT was measured three times, and vital signs were recorded accordingly.
NCT06165679
Data comparing prilocaine vs bupivacaine in equipotent doses in the elderly are lacking; therefore, the study will compare the effect of prilocaine vs bupivacaine on hemodynamics in spinal anesthesia for geriatric patients undergoing endoscopic urological surgeries
NCT07022314
This prospective observational study evaluates the real-time urine output response to fluid therapy and diuretics in cardiothoracic intensive care unit (CTICU) patients monitored with the FIZE kUO® device. The study aims to assess how continuous urine output monitoring can inform fluid management and improve patient outcomes post-cardiac surgery.
NCT06942091
This retrospective cohort study aims to evaluate the impact of traumatic brain injury (TBI) on hemodynamic status in trauma patients with surgically confirmed blunt bowel and mesenteric injuries (BBMI). A total of 169 adult patients treated at a Level I trauma center between 2009 and 2023 were analyzed and stratified based on the presence or absence of concomitant TBI. Clinical parameters such as shock, massive transfusion, transfusion requirements, morbidity, and mortality were compared. The study investigates whether TBI is an independent risk factor for acute hemodynamic instability in BBMI patients, with the goal of improving trauma care strategies and understanding the systemic effects of TBI, particularly through the lens of the brain-gut axis.