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29 active trials for Shock

RApid Fluid Volume EXpansion in Patients in Shock After the Initial Phase of Resuscitation.

Rapid volume expansion using repeated intravenous fluid boluses is a very common intervention performed in the intensive care unit (ICU) in the early days of resuscitation of patients with shock. Once passed the initial phase of resuscitation, the fluid boluses administered fail to effectively increase the patients' cardiac output in about 50% of cases. Pulse pressure changes or stroke volume changes induced by a Passive Leg Raising (PLR) test have acceptable/good ability to predict fluid responsiveness (in terms of cardiac output change) and may be systematically used in patients with persistent shock with the aim of limiting the total amount of fluid administered to patients by avoiding undue fluid boluses. One may suppose that such a volume expansion management policy could impact morbidity and mortality of shocked patients. Among the predictive indices available in clinical practice, the PLR test has the advantages of being usable regardless of the patients' respiratory status and cardiac rhythm. Changes in left ventricular stroke volume during the PLR test perform better that changes in pulse pressure to predict fluid responsiveness. However, in counterpart, pulse pressure changes during PLR can be assessed without the need of other hemodynamic exploration such central venous pressure measurement or cardiac output monitoring. The investigators hypothesized that strategies using either stroke volume changes or pulse pressure changes induced by the PLR test to decide wether a fluid bolus clinically deemed indicated should or should not be administered, may limit the amount of fluid received by the patients during the first 5 days of shock, improve their oxygenation index, and shorten the time passed under mechanical ventilation, as compared to a "liberal" strategy (usual care) that does not use predictive indices of fluid responsiveness.

Start: January 2016
Using Artificial Intelligence (AI)-Assisted Pulse Diagnosis Analysis on Precision Critical Medicine.

Precision/personalized medicine becomes an important part of modern medical system in the recent years. In the past, the treatments for patients have been decided by doctors according patients' symptoms and/or regular biochemical profiles. However, it is not uncommon that patients' condition varies tremendously even they have same diagnosis, and under such condition, treatment efficacy may be limited due to the heterogeneity among patients. Therefore, lack of therapeutic efficacy may be not really ineffective, and the main reason may be inadequate patient classification. For this reason, the "omics"-based personal/precision medicine emerges recently and becomes more and more important. However, in contrast to feasible and common "personalized" medicine, the approach of precision medicine to the molecular medicine level is still difficult, especially among patients in intensive critical units (ICUs). In contrast to cancer, which has remarkable advances in the past decades, the precision/personal medicine is more difficult in critical and emergent medicine. One reason is the amount of omics data is quite huge and thus dealing with omics data is time consuming. Therefore, it is not effective in daily clinical practice in ICUs care. For this condition, the investigators propose that the combination of clinical data, including pulse diagnosis by traditional Chinese medicine (TCM) doctor or ANSwatch wrist sphygmomanometer, fluid responsiveness by "Masimo" Radical-7 Pulse CO-Oximeter, and the specific database from monitors in ICUs may be a feasible way to predict outcome among ICU patients. There are two main goals for this study: (1) After establishing clinical traditional Chinese medicine (TCM) pulse diagnosis and ICU clinical parameters databases, acquiring and features of pulse diagnosis by applying AI and (2) analyzing the correlations between the features of pulse diagnosis and important clinical parameters.

Start: November 2020
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.

Start: July 2018
Bedside Visual Analysis of Sublingual Microcirculation in Shock Patients

In shock patients, fluid resuscitation, infusion of vasopressors and transfusion are guided on hemodynamic macrovascular parameters. Analysis of sublingual microcirculation in shock patients is predictive of mortality and organ dysfunction. To optimize the quality of the resuscitation in shock patients, it could be useful to have an assessment of sublingual microcirculation in addition to the macrovascular parameters usually assessed by the nurses. But, this requires to have a monitor of sublingual microcirculation easy to use and to analyze at the bedside. The primary outcome of the present study is to test the ability of visual analysis of sublingual microcirculation by nurses to predict needs for fluid challenge, vasopressors or transfusion in patients in shock. After ICU admission and study inclusion, the nurses in charge of the patient will perform a set of measurements of macrocirculatory and microcirculatory parameters every 4 h during the first three days after ICU admission and before and after every hemodynamic therapeutic intervention, such as fluid challenge, transfusion of red blood cells or change in catecholamine rate. The secondary outcomes are to test 1/ to test the ability of visual analysis of sublingual microcirculation to predict organ dysfunction (SOFA score), and 2/ to evaluate the relationship between hemodynamic macrovascular and microvascular parameters. Intensive care patients in shock who need sedation, mechanical ventilation and invasive hemodynamic monitoring (Pulse Contour Cardiac Output (PiCCO 2 device)) will be included. In addition, patients will be included only when patients will obviously stay more than 24 hours in the ICU.

Start: March 2018