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Toxemia clinical trials

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NCT ID: NCT05287477 Recruiting - Sepsis Clinical Trials

Passive Evaluation in Operational Environment of the AI Clinician Decision Support System for Sepsis Treatment

Start date: March 24, 2022
Phase:
Study type: Observational

Sepsis, or systemic infection, is a common reason for ICU admission and death throughout the world. Despite advances in the way we treat this condition, it remains a significant economic and healthcare burden. A key part of the treatment of sepsis is the administration of IV fluids and blood pressure medication. However, there is huge uncertainty around dosing of these drugs in an individual patient. A tool to personalise these medications could improve patient survival. The study team has developed a new method to automatically and continuously review and recommend the correct medication doses to doctors, which was created using artificial intelligence (AI) techniques applied to large medical databases. The researchers' previous work has shown it has the potential to improve patient survival rates. The tool will be capable of processing patient data within the electronic patient record of NHS hospitals in real-time to suggest a course of action. This tool will be evaluated and refined in simulation studies and then be tested in two NHS Trusts in "shadow mode" (results not provided to duty clinicians). This will allow comparison of actual decisions made and recommended decisions from the AI system. The second stage of this clinical evaluation will display the recommendations to clinicians to assess the acceptability of the tool and confirm technical feasibility to inform future clinical trials. The long-term expected benefits of this project are numerous: improved patient survival, reduced use of precious intensive care resources and reduction in healthcare costs.

NCT ID: NCT05283317 Completed - Sepsis Clinical Trials

Effect of Mesenchymal Stromal Cells on Sepsis and Septic Shock

Start date: March 11, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Methods:Ten patients were enrolled in the study. Adipose derived-MSCs infusions were given (1x 106/ kg, on 1st, 3rd, 5th, 7th and 9th days of therapy) together with Standard therapy. Before the MSCs applications, blood samples were collected for cytokine assessment (TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10). The clinical and laboratory improvements were recorded and compared with control groups selected retrospectively.

NCT ID: NCT05274776 Recruiting - EOS Clinical Trials

Safely Reduce Newborn Antibiotic Exposure With the Early-onset Sepsis Calculator

Start date: April 12, 2022
Phase: N/A
Study type: Interventional

Newborns are at risk for early-onset sepsis (EOS), which occurs within 72 hours after birth. The incidence of proven EOS is 0.5-2.0 per 1000 live births. The annual birth rate in the Netherlands is around 170.000, consequently the number of EOS cases varies between 85 to 340. However, about 5%, thus 8500, of late preterm and term newborns receive empiric antibiotic therapy in compliance with the current Dutch guideline. An alternative is the CE certified EOS calculator application, which calculates an individual EOS risk with treatment advice. In this prospective cluster-randomized multicenter trial the current Dutch guideline will be compared with the EOS calculator in newborns at risk for EOS. The primary objectives of this study are: 1. To investigate whether the use of the EOS calculator reduces antibiotic exposure in newborns with suspected EOS in the first 24 hours after birth. 2. To investigate the presence of one or more of the following four predefined safety criteria, namely 1) the need for any respiratory support, and/or 2) the need for an intravascular fluid bolus for hemodynamic instability due to sepsis, and/or 3) referral to a Neonatal Intensive Care Unit for sepsis treatment, and/or 4) proven EOS. Secondary objectives of the study are: 1. To investigate if the use of the EOS calculator decreases the total duration of antibiotic therapy in newborns with suspected EOS. 2. To investigate if the use of the EOS calculator decreases the percentage of antibiotic therapy started for suspected and, or proven EOS if symptoms started between 24-72 hours after birth. 3. To study the impact of (suspected) EOS on parents/guardians.

NCT ID: NCT05273034 Completed - Sepsis Clinical Trials

Effect of the 1-hour Sepsis Bundle on In-hospital Mortality in Patients With Sepsis in the Emergency Department

1BED
Start date: June 13, 2022
Phase: N/A
Study type: Interventional

Reducing the mortality and morbidity of sepsis is a worldwide priority for almost 20 years. Since an observational study in the NY state, which reported in-hospital mortality increased, associated with each supplemental hour to complete the sepsis bundle, SSC guidelines have decided in 2018 to recommend a short timeframe of 1-h to complete the sepsis bundle. This new recommendation is vividly debated due to a lack of evidences of its relevance. No trial has ever studied a sepsis intervention when applied as early as Emergency Department ED triage (newly recommended 1-h sepsis bundle consider time zero as time of ED triage). The aim of this trial is to demonstrate that the early implementation at ED triage of the 1-hour bundle by ED physicians improves in-hospital mortality in patients with sepsis, and therefore provides the required robust evidence for the SSC guidance to enhance physicians and stakeholder adherence. This is a superiority, international multicenter, open trial with a stepped wedge randomisation. All centers will recruit adult emergency patients with suspicion of sepsis as defined by a suspicion of infection and suspicion of life threatening organ dysfunction (quick SOFA or SOFA ≥ 2, hypotension or hyperlactatemia). According to the center period, the management of sepsis patients will be based either following the current recommended 1-hour sepsis bundle (intervention group) or at the discretion of the treating ED physician as in current routine practice (control group). There is no intervention that is "added" by the research.

NCT ID: NCT05267821 Recruiting - Clinical trials for Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

TRIPS
Start date: June 14, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The TRIPS study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyperinflammation in children with sepsis-induced multiple organ dysfunction syndrome (MODS).

NCT ID: NCT05266001 Recruiting - Clinical trials for Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome

GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS

GRACE-2
Start date: June 14, 2022
Phase: Phase 3
Study type: Interventional

The GRACE-2 study is a prospective, multi-center, double-blind, randomized controlled trial of the drug GM-CSF vs placebo in children with sepsis-induced multiple organ dysfunction syndrome (MODS) who have immunoparalysis with mild to moderate inflammation.

NCT ID: NCT05265130 Not yet recruiting - Sepsis Clinical Trials

The Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis

Start date: February 28, 2022
Phase: Phase 4
Study type: Interventional

This is a prospective single center pilot randomized controlled study to assess the efficacy and safety of YiQiFuMai injection (YQFM), a widely used Chinese medicine, as an adjunctive treatment for sepsis.

NCT ID: NCT05261607 Recruiting - Respiratory Failure Clinical Trials

Analysis of the Evolution of Mortality in an Intensive Care Unit

Start date: July 1, 1991
Phase:
Study type: Observational

The intensive care units is of the main components of modern healthcare systems. Formally, its aim is to offer the critically ill health care fit to their needs; ensuring that this health care is appropriate, sustainable, ethical and respectful of their autonomy. Intensive medicine is a cross-sectional specialty that encompasses a broad spectrum of pathologies in their most severe condition, and specifically has as its foundation the practice of comprehensive care of the patient with organ dysfunction and susceptible to recovery. Although critically ill patients are a heterogeneous population, they have in common the need for a high level of care, often requiring the use of high technology, specific procedures for the support of organ dysfunction and the collaboration of other medical and surgical specialties for their management and treatment. Since their origins in the late 1950s, intensive care units have been adapting to the changes arising from the best scientific evidence. In the late 1990s and early 2000s, there were some successful clinical trials published that had tested alternative management strategies in the ICU. Mechanical ventilation is an intervention that defines the critical care specialty. Between 1970 and the 1990s, the management focused on normalizing arterial blood gas with aggressive mechanical ventilation. Over the ensuing decades, it became apparent that performing positive pressure ventilation worsened lung injury. The pivotal moment in the mechanical ventilation story would be the low versus high tidal volume trial. This trial shifted the focus away from normalizing gas exchange to reducing harm with mechanical ventilation. Further, it paved way for further trials testing ventilation interventions (PEEP strategy, prone position ventilation) and nonventilation interventions (neuromuscular blockade, corticosteroids, inhaled nitric oxide, extracorporeal gas exchange) in critically ill patients. That evidence-based intensive care medicine has undoubtedly had an influence on the outcome of critically ill patients, in general, and, particularly, of patients requiring mechanical ventilation. Temporal changes in mortality over the time have been scarcely reported for patients admitted to intensive care unit. Objective of this study is to estimate the changes over the time in several outcomes in the patients admitted to an 18-beds medical-surgical intensive care unit from 1991 (year of start of activity) to 2026

NCT ID: NCT05246969 Completed - Sepsis Clinical Trials

Detecting Sepsis in Patients With Severe Subarachnoideal Hemorrhage

Start date: June 1, 2017
Phase:
Study type: Observational

The study aims to evaluate the suitability of the SOFA score implemented by the Sepsis 3 guideline to detect sepsis in patients suffering from subrarachnoid hemorrhage.

NCT ID: NCT05244018 Completed - Sepsis Clinical Trials

Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation

Start date: March 1, 2022
Phase: Phase 4
Study type: Interventional

There is a high prevalence of vitamin D deficiency in the critically ill patient population, with approximately 60% of patients found to be vitamin D deficient, (25(OH)D concentrations <20 ng/mL) and an additional 30% of patients being vitamin D insufficient, (25(OH)D = 20-30 ng/mL).Approximately 80% of sepsis/septic shock patients experience respiratory failure and require mechanical ventilation. Furthermore, several studies document that vitamin D deficiency could be associated with poor outcomes in critically ill patient.