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Septic Shock clinical trials

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NCT ID: NCT05491941 Recruiting - Septic Shock Clinical Trials

Assessment for Implementation Methods in Sepsis

AIMS
Start date: July 15, 2022
Phase: N/A
Study type: Interventional

Since the introduction of sepsis bundles, there have been multiple published trials that have demonstrated a consistent, strong association between implementation of sepsis "bundles" (3-hour bundle) and improved survival. The current proposal is a Hybrid 2, pragmatic, cluster randomized clinical effectiveness/implementation trial evaluating mortality and respiratory failure-based outcomes, in patients admitted to the emergency department with sepsis, comparing the effectiveness of implementation of the hour-1 bundle to 3-hour bundle, while facilitating adherence to both bundles. In addition, 4 distinct sepsis phenotypes will be derived from routine clinical data to identify specific patient phenotypes that allow for a more precision-based application of sepsis bundles in future studies.

NCT ID: NCT05428423 Recruiting - Sepsis Clinical Trials

Reliability of PVI Changes During Tidal Volume Challenge in ICU Patients

Start date: June 6, 2022
Phase:
Study type: Observational

The aim of this study is to assess whether changes in the plethysmography variability index, during a tidal volume challenge, can reliably detect simultaneous changes in arterial blood pressure pulsatility, in patients hospitalized in intensive care unit. If results will be positive, this will allow the test to be performed even in the absence of an invasive arterial catheter.

NCT ID: NCT05402553 Recruiting - Sepsis Clinical Trials

The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock

Start date: April 24, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Sepsis is a systemic inflammatory response that has deleterious effects and considered the leading cause of death in critically ill patients 1 . One of the hallmarks of severe sepsis is the progressive, injurious inflammatory response to infection, mediated by the excessive release of inflammatory mediators and consequently, associated with multiple organs damage 2 . Various studies have demonstrated that adverse outcomes in sepsis patients are closely related to the development of myocardial dysfunction 3 . The mortality of sepsis combined with cardiac functional insufficiency has increased significantly to 70%-90% 4 . Therefore, targeting cardiac insufficiency and heart injury may represent a novel treatment strategy. Several reports documented critical involvement of serotonin 5-hydroxytryptamine in the pathogenesis of sepsis. The aim of the current study is to evaluate the efficacy of ondansetron adjuvant use in patients with sepsis and septic shock.

NCT ID: NCT05386199 Recruiting - Sepsis Clinical Trials

The Role of Serotonin in Intensive Care Patients

SERO-22
Start date: May 25, 2022
Phase:
Study type: Observational

Sepsis, cardiac arrest and multiple trauma are potentially life-threatening conditions and common reasons for intensive care unit (ICU) admission. The aim of this study is to investigate the role of the signaling substance serotonin in blood in these conditions.

NCT ID: NCT05383963 Recruiting - Sepsis Clinical Trials

Evaluation of Parameters Collected From Routine Data for the Diagnosis of Sepsis and Septic Shock and Their Influence on Time to Diagnosis and Patient Outcome

Start date: July 15, 2022
Phase:
Study type: Observational

Retrospective observational study to develop a Machine Learning Algorithm to evaluate parameters collected from routine data for the diagnosis of sepsis and septic shock and their influence on time to diagnosis and patient outcome.

NCT ID: NCT05357339 Recruiting - Sepsis Clinical Trials

Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The sublingual microcirculation is impaired in sepsis and septic shock. Sidestream dark field imaging technology has been developed into a clinical tool to help the clinician assess the microcirculation at the bedside. The ideal resuscitation fluid has not been identified. The investigators aim to use this new bedside technology to establish the microcirculation properties of two popular resuscitation fluids.

NCT ID: NCT05349370 Recruiting - Sepsis Clinical Trials

Lactate Kinetics in Septic Shock

LKISS
Start date: December 28, 2022
Phase: N/A
Study type: Interventional

Lactate kinetics will be studied in hospitalized septic patients using a bolus injection of stable isotopically labeled lactate.

NCT ID: NCT05257759 Recruiting - Septic Shock Clinical Trials

Use of Neurostimulation as a Tool for Reconditioning the Neuromuscular System of Patients Admitted to the ICU for Septic Shock

STIMUREA
Start date: March 25, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05231720 Recruiting - Septic Shock Clinical Trials

Mannheim Register of Sepsis and Septic Shock

MARSS
Start date: December 3, 2019
Phase:
Study type: Observational [Patient Registry]

The study aims to investigate clinically and prognostically relevant parameters in patients with sepsis and septic shock within a monocentric observational clinical register.

NCT ID: NCT05225402 Recruiting - Septic Shock Clinical Trials

Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU

Start date: March 8, 2022
Phase:
Study type: Observational

In septic shock there is growing evidence of a state of hemodynamic "disconnection" with seemingly adequate macrocirculatory values despite actual microcirculation failing to meet cellular demand. Norepinephrine (NE) is recommended as first choice vasoactive agent for the treatment of septic shock. However, the dynamic effects of NE on macro- and microcirculation and perfusion parameters has not been described in detail in the context of septic shock, precluding rational individualized titration of NE and fluids, as recommended recently. In the present prospective observational multicenter study in adult septic shock patients, we intend to explore the effects of NE on preload dependency and tissue perfusion by evaluating the correlation and potential discrepancies between macro- and microcirculation both during titration of NE and after fluid resuscitation. The conclusions drawn from our study will contribute to the physiological knowledge necessary for establishing individualized evidence-based bedside management of hemodynamics in the setting of septic shock.