Active clinical trials for "Shock, Septic"

Studies have demonstrated that the use of a procalcitonin (PCT)-guided algorithm in combination with clinical judgment was associated with reduced antibiotic use without impacting mortality or treatment failure. Though several studies have evaluated the use of PCT in critically ill patients, there are limited studies that evaluated PCT in patients with cancer and many of the currently available studies have excluded immune-compromised patients. This is a randomized controlled trial that aims to evaluate the impact of a procalcitonin-guided algorithm on antibiotic utilization in critically ill cancer patients with sepsis. In addition, the study aims to evaluate the predictive value of PCT for predicting mortality and positive cultures.

The development of acute kidney injury (AKI) during septic shock is frequent and is associated with a high mortality rate. The reason of this increased mortality despite the use of renal replacement therapy is still unknown. The deleterious effects of uremic toxins (solutes accumulating with the loss of kidney function) has risen for the last decade in chronic kidney disease patients. Among those solutes, indoxyl sulfate (IS) is associated with the development of cardiovascular complications and impairment of immune response. The role of uremic toxins and particularly IS in the prognostic of septic kidney injury is unknown. The investigators propose to analyze the relation between the serum concentration of IS and the mortality of patients hospitalized for a septic shock who developed an AKI.

Patients hospitalized in the ICU are likely to develop sarcopenia due to a progressive and generalized decrease in muscle mass that is responsible for generalized muscle weakness known as resuscitation neuromyopathy. This neuromyopathy is known make weaning from mechanical ventilation more difficult, which prolongs the hospitalization of patients in the ICU and in hospital. The factors identified as being partly responsible for this neuromyopathy are: immobilization, undernutrition, prolonged duration of mechanical ventilation, inflammation (notably secondary to sepsis), and multivisceral failure. These factors are essentially found in patients in septic shock, which represents about 20% of patients admitted to the ICU, with a mortality rate close to 50%. If the management of septic shock is now well codified (i.e. vascular filling, antibiotics and/or treatment of the infectious focus by surgery +/- organ replacement therapy) as well as the early rehabilitation of ICU patients, no treatments has yet been proven to be effective in limiting the appearance of resuscitation neuromyopathy. For the last ten years, research using electrostimulation (ES) to improve muscle contraction seems to give encouraging results, both for length of hospital stay and the duration of mechanical ventilation, notably through the preservation or a significant increase in muscle strength. On the other hand, other studies did not show a significant effect on muscle strength. These conflicting results are partly related to the heterogeneity of the populations included in the studies and to the different ES approaches used to assess and recondition motor function. In the present STIMUREA study, an original approach is proposed based on experimental research work carried out for many years within U1093 (Pr Charalambos Papaxanthis) which focuses on ES, not of the muscle surface as in most studies carried out in the ICU, but an approach based on ES of the motor nerve. Indeed, the intensity of ES used in previous studies was based on a maximum tolerated intensity leading to a direct recruitment of the most fatiguable motor units (via the activation of motor axons) but leading, in fine, to a decrease in muscle strength. The U1093 research team and previous studies have shown that protocols using high stimulation frequencies (100Hz) associated with pulse widths of 1ms and delivered at low intensities (5-10% of the maximum voluntary contraction, MVC) at the level of the motor nerve, could increase the force developed during the contraction, while decreasing the discomfort induced by the high intensities. This increase in force would be due to the indirect activation of motor neurons via large diameter sensory afferents, thus leading to a recruitment of motor units similar to that observed during voluntary contractions. In a very recent study conducted in our laboratory (INSERM U1093), it was demonstrated that the application of ES to the motor nerve at low intensities did not induce discomfort in healthy subjects, but could induce substantial strength gains (+25%) with adaptations occurring at both in the muscles and the nerves. The proposed study is an innovative, randomized, pilot study based on motor nerve ES in a highly selected population of ICU patients in septic shock and therefore with a high risk of developing neuromyopathy, which is responsible for a significant increase in morbidity and mortality.

The Non-Invasive Cardiac Output Monitor (NICOM) is a non-invasive monitor capable of measuring cardiac output (CO) and cardiac index (CI), and stroke volume (SV) and stroke volume index (SVI) based on heart rate. Conceptually NICOM is a technology that utilizes a dynamic response characteristic in assessing the need for fluid administration, whereby SVI is measured before and after a fluid challenge with more fluid given only if SVI increases significantly with administered fluid. Dynamic response technologies are intended to replace older, "static" measures such as central venous pressure (CVP) and pulmonary capillary wedge pressures (PCWP) which are single point measurements utilized to assess the need to administer fluid. The aim is to pilot and evaluate the effectiveness of using The Non-Invasive Cardiac Output Monitor (NICOM) technology for goal-directed fluid resuscitation in adult inpatients with sepsis associated acute hypotension and/or evidence of septic shock (Lactate >= 4.0).

Background: Recent studies have questioned the safety of current fluid resuscitation strategies in patients with septic shock as prospective and observational data suggesting that the resulting fluid overload is associated with mortality. Two strategies have evolved to prevent or minimize fluid overload: restrictive fluid administration or active removal of accumulated fluid. While several small trials show benefits with a restrictive fluid administration regimen, active protocolized de-resuscitation was scarcely evaluated. The combination of both strategies yet warrants systematic evaluation. Aim: This study aims to assess the efficacy and feasibility of an early active de-resuscitation protocol in patients with septic shock. We hypothesize that the application of a structured early de-resuscitation protocol versus standard of care will lead to less fluid overload at day three after ICU admission. Study Intervention: Patients admitted to the ICU with confirmed or suspected septic shock (Sepsis-3 definition) will be randomized (1:1) to either the intervention or standard of care. In the intervention arm, patients are managed according to the REDUCE fluid management protocol during resuscitation and de-resuscitation.

The purpose of this trial is to assess patient important benefits and harms of IV fluid restriction vs. standard care fluid therapy in patients with septic shock.

The purpose of this study is : - to evaluate the hemodynamic tolerance of esmolol titrated to obtain a lowering of heart rate of 10% or 20%.

This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia.

In this clinical trial the effect of early administration of Vitamin C is investigated in patients admitted at the emergency department with sepsis or septic shock. When a patient has sepsis, his/her body is causing damage to its own tissues and organs as result of an infection. This can lead to septic shock. The patient has a low blood pressure, his/her organs stop working and the patient may even die. The aim of this trial is to investigate the efficiency of Vitamin C in sepsis and septic shock. Vitamin C is a vitamin present in various foods and has been approved as dietary supplement by the Belgian authorities. Over the years it has been proven that Vitamin C is very safe. In addition, several studies have shown that Vitamin C can also have a protective effect. It can reduce organ damage and increase survival rates. Although several studies suggest that Vitamin C can help fight sepsis, it is not yet used in practice. This Belgian trial, in which several hospitals participate, hopes to provide a clear answer to the question: "Should Vitamin C be administered to patients admitted in an emergency department with sepsis or septic shock?"

This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.