Clinical Research Directory

Tissue Perfusion Pressure for Predicting Fluid Responsiveness in Patients With Shock

This prospective observational study aims to evaluate the ability of tissue perfusion pressure (TPP) to predict fluid responsiveness in critically ill patients with shock and tissue hypoperfusion. Eligible patients requiring fluid resuscitation will undergo a standardized fluid challenge test. Hemodynamic parameters, including cardiac output and TPP, will be recorded before and after fluid administration. Fluid responsiveness will be defined according to the change in cardiac output following fluid loading. The study will assess the correlation between changes in TPP and cardiac output and evaluate the diagnostic performance of TPP for predicting fluid responsiveness. The results may support the use of TPP as a practical and physiologically relevant parameter for individualized fluid management in patients with shock.

Comparison of Allows Measurement of Cardiac Output Between Clearsight System and Transpulmonary Thermodilution

Correlation study between the data provided by two measurement systems, trans- pulmonary thermodilution and ClearSight © (non invasive), to determine the interest in routine use (cardiac output, cardiac index, stroke volume and blood pressure).

Critical Care Admission Following Emergency Department's Resuscitation Room Care

This prospective multicenter observational study aims to describe resuscitation room activity in France and to compare critical care admission within 24 hours between patients directly admitted to the resuscitation room and those admitted secondarily after initial emergency department management. Adult patients admitted to the resuscitation room over a 72-hour period in participating centers will be included. Data collection includes patient characteristics, triage severity, physiological parameters, critical interventions, and outcomes at 24 hours.

Fecal Lactate and Resuscitation Outcomes in Critical Illness

This study evaluates the prognostic value of fecal lactate and the fecal-to-serum lactate gradient as early biomarkers of tissue hypoperfusion in critically ill patients. While serum lactate is widely used, it may not accurately reflect splanchnic perfusion. This prospective observational study aims to determine whether fecal lactate levels obtained within the first 12-24 hours can predict poor response to resuscitation at 24 hours. The primary outcome is a composite of increased vasopressor requirements, persistent hyperlactatemia, worsening organ dysfunction, or death.

Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock

This clinical study was a multi-center, open-label, randomized controlled clinical trial. A total of 472 patients with early-stage cardiogenic shock were recruited and randomly divided into the experimental group and the control group, with 236 cases in each group. The HeartMed-HF digital out-of-hospital management was used to manage the patients in the experimental group, while the patients in the control group were managed according to the discharge guidance. The primary endpoints were 1-year all-cause mortality and unplanned readmission after randomization (excluding emergency department visits). Secondary endpoints (at 3 months, 6 months, and 12 months post-randomization) were: all-cause mortality, rehospitalization for HF, recurrent MI, ischemia-driven repeat revascularization, stroke, BARC 3-5 grade major bleeding, unplanned formal rehospitalization, types of GDMT medications or GDMT target dose achievement rate.

ICU Combined Assessment of Cardio-Respiratory Exercise

This study aims to investigate how sepsis and critical illness can impair the cardiovascular system and microcirculation in intensive care unit (ICU) patients, which can lead to long-lasting muscle weakness/dysfunction or ICU-Acquired Weakness (ICU-AW) and exercise limitations.

Distensibility Index of Inferior Vena Cava in Assessing Fluid Responsiveness: The Impact of Spontaneous Respiratory Effort

This study explored how inspiratory effort affects the accuracy of the distensibility index of inferior vena cava (dIVC) in assessing fluid responsiveness (FR).This prospective observational study was conducted in an intensive care unit of a university hospital and included shock patients receiving ventilation with spontaneous breathing activity. Hemodynamic parameters were collected before and after fluid challenge by the pulse indicator continuous cardiac output. dIVC was calculated by ultrasound, and respiratory effort was assessed using airway occlusion pressure (P0.1) and end-expiratory occlusion pressure (Pocc) before fluid administration. Responders were defined by a ≥10% increase in cardiac output (CO) after 250 mL saline infused in 10 minutes. The dIVC \> 18% was considered indicative of FR. Predictive performance was evaluated using area under receiver operating characteristic curves (AUROC), stratified by P0.1 and Pocc.

Right Ventriculo-Arterial Coupling During Fluid Loading in ICU Patients

Preload responsiveness and venous congestion have largely been investigated independently in recent literature. However, recent data report a similar incidence of venous congestion regardless of fluid responsiveness status, challenging the concept of a linear continuum between preload independence and fluid intolerance. These findings support the need for a more individualized hemodynamic management strategy that takes venous congestion risk into account. The right ventricle plays a central role in this framework. Its function is to maintain an adequate venous return pressure gradient to ensure cardiac output while limiting upstream venous congestion, under strong dependence on its afterload. In physiological conditions, the right ventricle adapts to changes in afterload by increasing contractility to preserve right ventriculo-arterial coupling and optimize its performance. In chronic cardiopulmonary diseases, right ventriculo-arterial uncoupling is a well-established prognostic factor, including the presence of occult uncoupling revealed by fluid loading. In critically ill patients, right ventricular systolic dysfunction associated with venous congestion-defining right heart failure-is strongly associated with increased mortality, as is right ventriculo-arterial uncoupling itself. To support the concept of fluid tolerance, the investigators hypothesize that impairment of right ventriculo-arterial coupling may exist or occur during fluid loading in critically ill patients, independently of preload responsiveness, and may be associated with worsening upstream venous congestion.

Impact of Sodium Profiling During Haemodialysis on Haemodynamic Tolerance and Sonographic Extravascular Lung Water in Shocked Patients With Acute Kidney Injury

A study conducted to evaluate the effects of sodium profiling haemodialysis compared with conventional haemodialysis on hemodynamic tolerance and extravascular lung water in critically ill patients with AKI and shock.

Peripheral pULSe Assessment and Arterial pRessure (PULSAR)

This prospective multicenter observational study aims to investigate the relationship between palpable peripheral pulses and simultaneously measured arterial blood pressure in adult patients with circulatory shock or impending circulatory failure. Peripheral pulse palpation is routinely used in emergency medicine, trauma care, critical care, and cardiopulmonary resuscitation as a rapid clinical assessment of circulation. However, the association between palpable pulses and actual arterial blood pressure remains poorly validated. Patients treated in emergency departments, intensive care units, operating rooms, and other acute care settings will undergo routine pulse palpation at predefined anatomical locations including carotid, femoral, and radial arteries. Simultaneously measured non-invasive and/or invasive arterial blood pressure values will be recorded from routine clinical monitoring systems. Additional clinical variables relevant to circulatory status will also be collected. The study seeks to define blood pressure thresholds associated with pulse palpability and evaluate the agreement between invasive and non-invasive blood pressure measurements in patients with circulatory shock.

Simple Observational Critical Care Studies

Each year approximately 3000 patients are admitted to the intensive care unit (ICU) in the University Medical Center Groningen (UMCG). In-hospital mortality of patients with emergency admission approaches 25%. Predicting outcome in the first hours after ICU admission, however, remains a challenge. An vast amount of scoring systems has been developed for mortality prediction. Well known models, such as the LODS, MODS, CCI, SOFA, ODIN and the different generations of the APACHE, MPM and SAPS, are increasingly compared with new models, such as the SICULA, ICNARC, ANZROD and SMS-ICU. The predictive value of scoring systems deteriorates over time due to changes in patient characteristics and treatment, making it crucial to update existing models or develop new models. Other reasons given for the need of models are the complexity and lack of availability of variables in some of the existing scoring systems, the better discriminating value while using simple, standardly measured variables, and the limited generalizability of some scoring systems in different patient populations. Not only are simple systems (such as the CIS and SMS-ICU) found to be at least as predictive for mortality as complex models such as the APACHE IV, but, while using simplified systems, mortality can also be reasonably predicted within only a few hours after admission. Both simplicity and the potential to predict mortality shortly after admission increase the usability, and consequently the reliability, of those prediction models. This increases the potential of those models to be used in practice. Most studies however compare only two to four models in their patient population and lack in their description of the performance of the different models. Parameters necessary to compare the performance of models are at least calibration, discrimination, negative predicting value, positive predicting value, sensitivity and specificity. Lacking an adequate description of the performance of the model limits to what extent the study can be used to compare models in different populations. Thus, all usable models should be compared with newly build models, and the performance of the different models should be extensively described to allow comparison of the models. Not only models based on simple, readily available variables available within hours after admission are promising, but also the concept of combining measurements straight after ICU admission with information on the course of illness. It is likely that the course of a variable over time is more indicative than a static measurement. This study will provide a structure in which every patient admitted to the ICU will be investigated and included within 3 hours and after 12 hours after admission, making longitudinal measurements and various add-on studies possible. Longitudinal measurements are the first example of an add-on study; another example is the capability of nurses and physicians to predict outcome. Current evidence suggests that physicians might predict mortality more accurately than scorings systems. This finding may, however, be highly biased, since at least physicians play a major role in end-of-life decision making. More recent studies also focus on the accuracy of nurses in predicting mortality, with diverse outcomes. The role of other health care professionals, like residents and students, remain to be studied. Implementing a systematic data collection process is the first step towards making data-driven research possible, a growing need in medical disciplines such as critical care, which requires increasingly more accurate prognostic models. Therefore, the aim of this study is to systematically collect data of all selected variables, thus minimizing incompleteness, and allowing for the calculation of mortality prediction scores according to currently available mortality or severity of disease prediction models. Moreover, during investigation reliability of measurements could be checked for validity. This creates the possibility to compare the performance of all models in one population and identify models which are useful to predict severity of disease. A registry will be created with this primary objective which also provides the opportunity to start multiple ''add-on'' studies for specific research questions. Examples of add-on studies are 1) the association between time-dependent variables which are longitudinally measured, and mortality/acute and chronic co-morbidity, 2) the association between fluid status and acute kidney injury, and 3) not only the capability of the treating physician to predict mortality, but also the capability of the nurses, residents and students to do so. Purpose: The purpose of this study is to expand the infrastructure for a registry with longitudinal and repeated measurements, shortly after admittance, which is flexible to incorporate temporarily added specific research questions on the outcome of critically ill patients.

Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children Using Transthoracic Echocardiography

Initial fluid resuscitation remains the first treatment step for most children experiencing circulatory failure and/or systemic hypotension. Only one-half of these patients respond to fluid administration by a significant increase in cardiac output. A positive fluid balance is a poor prognostic factor that increases mortality. There are few markers validated in children to assess volume reactivity by dynamic ultrasound parameters mainly based on heart-lung interaction. In this work, the investigators propose to investigate whether dynamic parameters validated in adults, such as the superior vena caval collapsibility and the variability of cardiac output during an end-expiratory and end-inspiratory occlusion, are also reliable indicators of volume responsiveness in sedated children under controlled-mode ventilation.

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.

Effectiveness of Midodrine as an Adjuvant to Norepinephrine in Weaning Critically Ill Patients From Vasopressors

This study aims to evaluate the effectiveness of midodrine as an adjuvant to norepinephrine in weaning critically ill patients from vasopressors

Augmented Pacing for Shock in the Cardiac Intensive Care Unit

The goal of this clinical trial is to learn if backup pacing at an increased rate improves hemodynamics in adults with relative bradycardia, a permanent pacemaker, and cardiogenic shock. The main question it aims to answer is: Does increasing the backup pacing rate to 100 beats per minute lead to improved cardiac index compared to a backup pacing rate of 75 beats per minute Participants who are already hospitalized in the Cardiovascular Intensive Care Unit with a permanent pacemaker and pulmonary artery catheter in place will be enrolled in this study. Participants will be exposed to each pacemaker rate in a randomized order with hemodynamics assessed after 10 minutes at each rate.

A Proof-of-concept Study of Ultrasound Stimulation of the Neck to Enhance Anti-shock Efficacy

The objective of this clinical study is to evaluate the initial efficacy and safety of LIPUS as an adjunct to standard therapy in patients with shock. The investigators will invite patients to participate in a proof-of-concept study investigating the efficacy of neck ultrasound stimulation to enhance anti-shock treatment, involving brief exposure to low-intensity pulsed ultrasound. This study examines whether LIPUS can enhance blood pressure in patients with shock, improve the efficacy of antihypotensive treatment, and reduce the dosage and duration of vasoactive drugs during active pharmacological therapy. By applying LIPUS as an adjunct to conventional treatment in clinical cases of shock, we aim to determine the clinical value of LIPUS and establish a theoretical foundation for developing innovative new therapies for shock.

The Prevalence of the Aortic to Radial Pressure Gradient in States of Shock, Outside the Context of Cardiac Surgery, a Prospective Study

First described in cardiac surgery, the aortic to radial pressure gradient (ATRAP) is the cause of an underestimation of the aortic pressure with a measure assumed with a radial catheter, and he can concert 1 of 3rd patients. The risks factor well known are small height, previous hypertension, long and difficult surgery, radial artery diameter less than 1.8mm. The ATRAP definition is a pressure difference between radial and femoral (same of the aortic pressure) pressure of 25mmHg on the systolic pressure, or a pressure difference on the mean pressure of 10mmHg, both measures realised by arterial canulation, and with a duration superior than 5 minutes. If this gradient appears in pathophysiological specifics situations, there is a risk of inappropriate administration of vasopressors, with more hospitalisation days, more side effect of vasopressors like an augmentation of myocardial work. The ATRAP is documented in septic shock with a prevalence between 21% and 27%. The ATRAP can appear in shocks, moreover with doses of equivalent norepinephrine of 0.5 µg/kg/min who is use for the definition of refractive shock, the difference between the two pressure is higher if the dose of equivalent norepinephrine is higher than 1µg/kg/min. But the prevalence and risks factors are barely unknowns in this situation. Most of the time, a radial arterial catheter is used for hemodynamic monitoring for his simplicity of utilisation and the lows complications associated. Some medical teams in cardiac surgeries, or in intensive care unit (ICU) for the management of shocks used often radial and femoral arterial catheter. It seems there is no at risk for the utilisation of a radial and femoral arterial canulation. Out of the situation of cardiac surgery, there is a lack of information of the ATRAP, the objective of the study is to evaluate the prevalence of the ATRAP in shock, out of the situation of cardiac surgery.

Methylene Blue for the Prevention of Hypotension During Hemodialysis

Hypotension is a common complication of intermittent renal replacement therapy. Methylene blue, an inhibitor of nitric oxide synthesis, has been suggested to improve hemodynamics during renal replacement therapy in ambulatory patients, but evidence is lacking for critically ill patients. This trial will assess whether methylene blue can improve hemodynamics and blood pressure for patients with shock requiring renal replacement therapy.

Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines

The purpose of this study is to assess the hypothesis that, as compared to early intravenous feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality in critically ill patients treated with mechanical ventilation and vasoactive drug.

Assessment of Stroke Volume in Shock Using Echocardiography Versus Bioreactive Impedance

This study aims to evaluate the correlation between stroke volume measurements obtained by transthoracic echocardiography and bioreactance-based noninvasive cardiac output monitoring. The primary objective is to assess the level of agreement between these two modalities in critically ill patients.

Trendelenburg as a First-line Intervention in Critically Ill, Sedated, Invasively Mechanically Ventilated, Hypotensive Patients

A pilot randomized controlled trial to evaluate the efficacy and safety of Trendelenburg position in critically ill patients with hypotension, mainly patients with septic shock and post operative vasoplegia. The main aim is to assess whether Trendelenburg position can improve organ function through a reduction in the need of fluid infusion and dose of vasopressors. Patients will be screened for participation in the study and eventually randomized based on a balanced randomization scheme (1:1) to Trendelenburg position up to 72 hours after intensive care unit (ICU) admission or Semirecumbent position (standard of care).

Effects of Increasing Mean Arterial Pressure on Renal Function in Patients With Shock and With Elevated Central Venous Pressure

The purpose of this study is to assess the effect of a higher mean arterial pressure on renal function for patients with shock and elevated central venous pressure.

SODium BICarbonate for Metabolic Acidosis in the ICU

This trial aims to assess if, among adults in the ICU with metabolic acidosis, an infusion of sodium bicarbonate diluted in 5% dextrose, compared with an infusion of 5% dextrose, reduces Major Adverse Kidney Events within 30 days of randomization.

Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality

This study aims to understand the role of extracellular vesicles (EVs) in extremely premature infants, those born before 28 weeks of gestation. EVs are tiny particles released by cells that carry important information about the body's condition. In extremely premature infants, blood vessels may not function properly, leading to serious health problems such as bleeding in the brain, lung injury, or severe infections. Researchers believe that analyzing EVs in the umbilical cord blood of these infants may help predict which babies are at higher risk of developing these complications. By studying the size, number, and type of EVs, the team hopes to identify early markers that can guide doctors in providing better care. The study will collect cord blood from 30 eligible infants born at the CHU of Montpellier. Blood samples will be processed to isolate platelet-poor plasma, which contains EVs. This plasma will be stored in a biobank, allowing future research on EVs and their role in extreme prematurity. EVs will then be analyzed in the laboratory to assess their characteristics and any links to severe health issues. The findings from this study could improve understanding of circulatory problems in extremely premature infants, help identify early predictors of severe complications, and inform better monitoring and treatment strategies. The creation of a plasma biobank also provides a valuable resource for future research to enhance care and outcomes for this vulnerable population.