Clinical Research Directory

Fluid Responsiveness in Laparoscopic Surgery: End-Expiratory Occlusion Test Versus Mini-Fluid Challenge

Background Fluid management is central to perioperative care, but only about half of surgical patients increase their stroke volume after a fluid challenge. Dynamic indices such as pulse pressure variation and stroke volume variation are often unreliable during laparoscopy, because of low tidal volume ventilation and carbon dioxide (CO2) pneumoperitoneum. Functional hemodynamic tests may overcome these limitations. In the Mini fluid chAllenge aNd End-expiratory occlusion test to assess flUid responsiveness in the opeRating room (MANEUVER) study (NCT03808753), conducted in open abdominal surgery, the mini-fluid challenge predicted fluid responsiveness well, whereas the end-expiratory occlusion test did not. Pneumoperitoneum raises intra-abdominal pressure instead of abolishing it, so these results cannot be extrapolated to laparoscopy. Design FLUID-LAP is a prospective, multicenter, observational diagnostic-accuracy cohort study conducted in four Italian centers and reported according to the Standards for Reporting of Diagnostic Accuracy (STARD) 2015 statement. Each patient is their own control: both index tests and the reference standard are performed in sequence in the same patient during a period of stable intraoperative hemodynamics, so the resulting receiver operating characteristic (ROC) curves are correlated. The study replicates the design of MANEUVER, changing only the surgical setting. Ventilation (volume-controlled, 7 ml/kg predicted body weight), the reference fluid challenge and uncalibrated pulse-contour monitoring are the same, to allow direct comparison with the open-abdomen data. Procedures Tests are performed under standardized baseline conditions (stable pneumoperitoneum and position, unchanged ventilation, no recent drug changes or surgical manipulation, arterial waveform checked with a square-wave test). The order of the two index tests is chosen by the attending anesthesiologist, is recorded for every patient, and is analyzed as a pre-specified covariate. A 3-minute return to steady state separates the tests. The complete 4 ml/kg fluid challenge is given after both tests. The maneuvers are already part of routine goal-directed practice, and no treatment decision is dictated by the protocol. Patient safety always prevails over the protocol. Analysis The primary analysis compares the areas under the ROC curves (AUC) of the two tests using the DeLong test. The expected AUCs are 0.90 for the mini-fluid challenge and 0.75 for the end-expiratory occlusion test. With 80% power and a two-sided alpha of 0.05, 87 evaluable patients are required; 104 will be enrolled to allow for 15% attrition (26 per center). Pre-specified analyses address the mathematical coupling between the mini-fluid challenge and the reference challenge, the effect of test order, and subgroups by intra-abdominal pressure and patient position.

Internal Jugular Vein and Inferior Vena Cava Collapsibility Indices as a Guidance of Fluid Responsiveness in Septic Shock Cancer Patients

This study aimed to compare between internal jugular vein and inferior vena cava collapsibility indices as a guidance of fluid responsiveness in septic shock cancer patients.

Hemodynamic Evaluation and Fluid Response Observation Through Respiratory Maneuvers

This study evaluates whether respiratory maneuvers can induce measurable hemodynamic changes and whether these changes may be used to assess fluid responsiveness in healthy volunteers. Hemodynamic parameters are continuously monitored non-invasively during four respiratory maneuvers, passive leg raising, and a fluid challenge. The hemodynamic responses to individual respiratory maneuvers are compared with the response to fluid administration.

Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock

Hemorrhagic shock from severe bleeding is a leading cause of preventable death in trauma patients. Intravenous (IV) fluid resuscitation is essential for stabilizing blood pressure and organ perfusion, but administering too much or too little fluid can cause severe complications. Only about half of hemodynamically unstable patients show an increase in cardiac output after receiving fluids. Emergency physicians often use bedside ultrasound to measure respiratory changes in the inferior vena cava (IVC), known as the IVC collapsibility index (IVC-CI), to predict whether a patient will benefit from fluids. However, obtaining clear IVC views can be difficult or impossible in trauma patients due to abdominal pain, obesity, or abdominal injuries. Evaluating the subclavian vein (SCV) under the collarbone provides a potential alternative window. The main purpose of this study is to compare the diagnostic accuracy of the subclavian vein collapsibility index (SCV-CI) against the inferior vena cava collapsibility index (IVC-CI) for predicting fluid responsiveness in adult trauma patients presenting with hemorrhagic shock. Eligible adult trauma patients with hemorrhagic shock will undergo rapid bedside point-of-care ultrasound upon presentation to the emergency department. Physicians will measure respiratory diameter variations in both the subclavian vein and inferior vena cava. Patients will then receive a standardized fluid challenge of 10 mL/kg intravenous balanced crystalloid solution over 10 to 15 minutes as part of resuscitation. Fluid responsiveness will be assessed by measuring changes in blood flow through the neck using carotid artery Doppler ultrasound before and 5 to 10 minutes after the fluid challenge. The study will determine whether subclavian vein ultrasound offers comparable diagnostic performance and greater feasibility compared to inferior vena cava ultrasound in emergency trauma resuscitation.

Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Consequence and Intraoperative Indicator of Fluid Responsiveness

This study investigates whether two simple bedside tests - the Passive Leg Raising (PLR) test and the Pleth Variability Index (PVI) - can predict a drop in blood pressure that sometimes occurs during a lung-opening procedure called an Alveolar Recruitment Maneuver (ARM). ARM is routinely performed during general anesthesia to prevent lung collapse and improve oxygen levels. However, in some patients - particularly those with low fluid levels - ARM can cause a temporary but significant drop in blood pressure (hypotension), which may require immediate treatment. In this prospective observational study, adult patients scheduled for elective non-cardiac, non-thoracic surgery under general anesthesia will be enrolled. Before each ARM is performed, PLR test and PVI values will be measured. We will then evaluate how well these measurements predict whether the patient will develop ARM-induced hypotension. If PLR and PVI can reliably identify patients at risk, clinicians may be able to take preventive steps before performing ARM, making the procedure safer for vulnerable patients.

PVI Predictors in Laparoscopic Hysterectomy

This observational study investigates the predictors of Pleth Variability Index (PVI) changes in euvolemic patients undergoing laparoscopic-assisted vaginal hysterectomy (LAVH). The primary objective is to quantify changes in PVI (ΔPVI) across six intraoperative time points associated with positional shifts. Secondary objectives include identifying key predictors of significant PVI change (ΔPVI ≥ 5%), such as passive leg raising, Trendelenburg position, body mass index (BMI), and intraabdominal pressure. Additional variables including perfusion index, mean arterial pressure, bispectral index, skin temperature, age, and anesthetic agent will be evaluated as potential modulators. Findings aim to support individualized fluid management strategies in LAVH.

Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients

The Pressure Recording Analytical Method, invasive hemodynamic monitoring, is an uncalibrated pulse contour analysis, installed in the Mostcare® system that allows a continuous estimation of the stroke volume and thus the cardiac output, by the relationship between the area under the curve of the systolic portion of the arterial blood pressure curve and the dynamic impedance of the cardiovascular system. The objectives of the study are to determine if the parameters measured by Mostcare® make it possible to predict the response to volume expansion in pediatric surgical critical care patients, sedated, intubated and ventilated, by comparing the changes in stroke volume, induced by a volume expansion, measured by trans-thoracic echocardiography.

Prediction of Fluid Responsiveness Using the Femoral Vein-to-Artery Diameter Ratio

This prospective single-center observational study aims to evaluate whether the ultrasound-measured femoral vein-to-femoral artery diameter ratio can predict fluid responsiveness in mechanically ventilated adult intensive care patients with acute circulatory failure or shock. Only patients who already have PiCCO monitoring as part of routine clinical care and for whom a fluid challenge is clinically indicated will be included. No additional invasive procedure will be performed for study purposes. Cardiac index will be measured with PiCCO before and after administration of 500 mL balanced crystalloid over 10 minutes, and femoral vein and femoral artery diameters will be measured by bedside ultrasonography. Fluid responsiveness will be defined as an increase of more than 10% in cardiac index after fluid administration. The study will assess the diagnostic performance of the femoral vein-to-femoral artery diameter ratio as a practical bedside parameter to support hemodynamic decision-making in critically ill patients.

Fluid Management and Individualized Resuscitation in Sepsis

The goal of this clinical trial is to find out if a personalized treatment approach can improve care for people with sepsis in the emergency department (ED). Sepsis is a life-threatening condition that happens when the body has an uncontrolled response to an infection. This can lead to low blood pressure, organ failure, and death if not treated quickly. Right now, most people with sepsis receive a standard amount of fluids to raise their blood pressure. But this one-size-fits-all approach can lead to fluid overload and other complications. Because each person responds differently, this study will test whether a more personalized treatment-based on how the heart responds to fluids-can lead to safer and more effective care. The study will include 188 adults who come to the ED at the University Medical Centre Groningen (UMCG) with suspected sepsis in need of hemodynamic resuscitation. Everyone in the study will receive fluids to support their blood pressure. Participants will be randomly assigned to one of two groups: * Personalized treatment group: Fluids and vasopressors (medications that raise blood pressure) will be given based on how the heart responds to each fluid dose. This response is measured using a non-invasive monitor that tracks stroke volume index (ΔSVI)-a measure of how much blood the heart pumps. * Standard care group: Fluids will be given based on current guidelines (30 milliliters per kilogram of body weight), as decided by the treating doctor. Researchers will compare how much fluid is given during the first 3 hours of care. They will also look at: * When and how much vasopressor medicine is used * How well blood pressure and circulation respond * Signs of organ recovery or damage * How long participants stay in the hospital * Any problems or side effects during treatment The researchers hope that this personalized approach will lead to using less fluid, starting vasopressors earlier, and helping people with sepsis recover more safely and quickly.

Hemodynamic Monitoring and Fluid Responsiveness in Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO) - "HemodynamECMOnitoring-VA Study"

In extracorporeal membrane oxygenation (ECMO), blood is drawn out of the body via tubes, oxygenated in an artificial lung; and then pumped back into the blood vessels. This allows the supply of oxygen-rich blood to the organs (brain, heart, lungs, kidneys, liver, intestines, etc.) to be maintained. Continuous monitoring of cardiac function and circulatory status (blood pressure, blood flow to organs) is very important in intensive care medicine in order to control the administration of circulation-supporting medication and infusions. Various devices are routinely used for this task. However, in the specific situation of ECMO treatment, the measurements of these devices could be affected due to the artificial circulation; outside the body. The purpose of this study is therefore to test the accuracy of different methods of circulation monitoring during ECMO treatment.

Hemodynamic Monitoring and Fluid Responsiveness in Venovenous Extracorporeal Membrane Oxygenation (VV ECMO) - "HemodynamECMOnitoring-VV Study"

In extracorporeal membrane oxygenation (ECMO), blood is drawn out of the body via tubes, oxygenated in an artificial lung; and then pumped back into the blood vessels. This allows the supply of oxygen-rich blood to the organs (brain, heart, lungs, kidneys, liver, intestines, etc.) to be maintained. Continuous monitoring of cardiac function and circulatory status (blood pressure, blood flow to organs) is very important in intensive care medicine in order to control the administration of circulation-supporting medication and infusions. Various devices are routinely used for this task. However, in the specific situation of ECMO treatment, the measurements of these devices could be affected due to the artificial circulation; outside the body. The purpose of this study is therefore to test the accuracy of different methods of circulation monitoring during ECMO treatment.

Fluid Responsiveness and Venous Congestion Evolution During Volume Expansion

Fluid responsiveness is a critical determinant guiding fluid therapy in critically ill patients. However, excessive fluid administration can result in fluid overload, leading to venous congestion and worse clinical outcomes. Venous congestion, a marker of impaired fluid clearance, is increasingly recognized as a significant contributor to poor prognosis. Previous studies have demonstrated the coexistence of fluid responsiveness and venous congestion in critically ill patients. Notably, these studies were limited by the absence of fluid challenge-the gold standard for assessing fluid responsiveness-leaving the dynamic relationship between fluid responsiveness and venous congestion incompletely understood. This study aims to investigate the interplay and temporal evolution of fluid responsiveness and venous congestion following a standardized fluid challenge in critically ill patients.

Passive Leg Raise and Mini-fluid Challenge Effect on Various Cardiac Output Surrogates for Fluid Responsiveness

In the critically ill population, fluid administration in an unstable patient is perhaps the most common intervention that is performed. Uncorrected hypovolemia with inappropriate vasopressors lead to organ hypoperfusion where as overzealous fluid administration especially in ARDS (Adult respiratory distress syndrome) can increase mortality. It has been estimated that only 50% of hemodynamically unstable critically ill patients are volume responsive, hence dynamic assessment of preload responsiveness has been proposed to better identify those individuals who would benefit from fluid bolus.

Fluid Responsiveness in Prone Patients

To assess fluid responsiveness in prone patient