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Sepsis clinical trials

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NCT ID: NCT05980494 Recruiting - Sepsis Clinical Trials

Lung Ultrasound Score and Inferior Vena Cava Diameter Compared to Pulse Pressure Variation

Start date: September 13, 2022
Phase: N/A
Study type: Interventional

Evaluation and management of intravascular volume are a central challenge for the critical ill patients. Hypotensive patients are commonly resuscitated with intravenous crystalloid fluid as a recommendation for treatment of many shock states. There has been a growing interest in the implementation of lung ultrasound in critical care management in the last decade as it is easy, bedside, non-expensive, non invasive and radiation free. The object of the current study is to assess the ability of lung and inferior vena cava sonography versus pulse pressure variation to predict fluid responsiveness in patients with circulatory failure on mechanical ventilation.

NCT ID: NCT05979545 Recruiting - Clinical trials for Ventilator Associated Pneumonia

EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics

RAPID
Start date: December 12, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to propose a seamless intervention linking rapid bacterial isolate identification and antibiotic resistance gene detection and targeted antibiotic prescription to minimise time between infection onset and appropriate treatment in patients with Pseudomonas aeruginosa or carbapenemase producing Enterobacterales infections. This is an investigator initiated trial. The primary hypothesis is that these interventions will lead to improved clinical outcomes amongst patients with hospital-acquired bloodstream infection, hospital-acquired pneumonia or ventilator-associated pneumonia due to carbapenem non-susceptible Pseudomonas aeruginosa or Enterobacterales, compared to standard antibiotic susceptibility testing. Patients will be randomised to either a control or intervention arm. Patients randomised to the intervention arm will have relevant specimens analysed by rapid microbiological diagnostics and will have early availability of ceftazidime-avibactam if appropriate. Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics will be available to these patients as per usual institutional practice.

NCT ID: NCT05979038 Recruiting - Sepsis Clinical Trials

Clinical Evaluation of the Effect of Metformin in Sepsis

Start date: September 10, 2023
Phase: Phase 3
Study type: Interventional

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. It is considered a condition that arises when the body's response to an infection injures its own tissues and organs. The pathogenesis of sepsis is very complicated as it involves imbalance in inflammatory response, immune dysfunction, mitochondrial damage, coagulopathy, neuroendocrine immune network abnormalities, endoplasmic reticulum stress, autophagy, and other pathophysiological processes, and leads to organ dysfunction. Inflammatory Imbalance represents the most critical basis of sepsis pathogenesis. Sepsis is associated with many biochemical abnormalities that is correlated with patients' prognosis and risk of mortality including increased levels of lactate, procalcitonin and inflammatory cytokines as TNF alpha. Metformin is an oral anti-diabetic drug from the class of biguanides. It is the first line treatment of diabetes type 2. It is widely used as it has good safety profile, low side effect and cheap cost. Metformin has been reported to have an anti-inflammatory and anti-microbial effect. Some studies have shown that metformin has a beneficial effect in sepsis patients. Our study will be the first prospective controlled randomized trial to assess the clinical outcome of metformin in patients with sepsis.

NCT ID: NCT05978154 Recruiting - Sepsis Clinical Trials

Thigh Muscle Mass and Muscle Wasting in Patients in the Emergency Department

Start date: July 28, 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate whether thigh muscle mass and muscle wasting are associated with mortality in patients who visit the emergency department. The main questions it aims to answer are: - Is thigh muscle mass associated with mortality in patient who visit the emergency department? - Does muscle wasting exist during staying in the emergency department? - Is muscle wasting associated with mortality in patient who visit the emergency department? Participants will be evaluated for serial thigh muscle mass using point-of-care ultrasound at the emergency department.

NCT ID: NCT05977153 Recruiting - Clinical trials for Mechanical Ventilation Complication

CT for Personalized Mechanical Ventilation

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to compare two different ways of helping patients with a condition called sepsis who need help breathing using a machine called a ventilator. The investigators want to study which way of setting the ventilator is better for the lungs. Here are the main questions the investigators want to answer: 1. How does the amount of air in the lungs and the way it moves differ between the two ways? 2. How does the way air spreads out in different parts of the lungs differ between the two ways? In this study, the investigators will take special pictures of the lungs using a machine called a CT scan. The pictures will show us how much the lungs stretch and how much air is in different parts of the lungs. The investigators will compare two different ways of using the ventilator: one personalized for each patient based on their breathing, and another way that is commonly used. By comparing these two ways, the investigators hope to learn which one is better for helping patients with sepsis who need the ventilator. This information can help doctors make better decisions about how to care for these patients and improve their breathing.

NCT ID: NCT05975671 Recruiting - Sepsis Clinical Trials

Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis

REVAMP
Start date: August 21, 2023
Phase: N/A
Study type: Interventional

The goal of this quasi-experimental interventional study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care Pediatric Intensive Care Units (PICU). There are two groups of subjects in this study: PICU clinicians/sepsis stakeholders and patients admitted to one of the participating PICUs during the study period. The intervention will at a minimum include: - Implementation of a clinical guideline indicating when vancomycin should and should not be used - Unit-level feedback on overall vancomycin use within and across centers - Clinician education.

NCT ID: NCT05971979 Recruiting - Sepsis Clinical Trials

Therapeutic Drug Monitoring - Targeting IMproved Effectiveness

TDM-TIME
Start date: December 14, 2023
Phase:
Study type: Observational

Severe infections can be caused by various organisms, such as bacteria or viruses, and lead to otherwise healthy people getting very unwell, sometimes needing treatment in hospital or even intensive care. For the treatment of bacterial infections to be successful, the correct antibiotics need to be given promptly. Early in the course of illness, clinicians often do not know exactly which bacteria are causing the infection. Furthermore, patients differ in terms of how their bodies process the antibiotics they are given; this means that some may get too much and others too little. This can in turn lead to some patients not being fully cured, and others coming to harm due to side effects of higher doses of these drugs. For certain types of antibiotics, clinicians are able to measure their levels in the bloodstream, which can help guide dosing. This is called therapeutic drug monitoring, and is commonly used in clinical practice. One of the problems with therapeutic drug monitoring is that it is often not available outside of regular working hours, is costly, and most importantly, provides clinicians with useful information only after a few days of treatment have already been completed. This may be too late to treat these severely ill patients with life-threatening infections, where early and appropriate treatments matter. The aim of our study, called TDM-TIME, is to look at how long it takes for blood samples to get from the patient to the laboratory to be measured, with the results then communicated back to clinicians. We are further looking to investigate whether steps can be taken to improve these timings, which would lead to shorter times until treatments can be improved. As our study is observational, we will not change anything about the treatment of our patients, but will only be measuring levels of antibiotics in their blood.

NCT ID: NCT05969327 Completed - Clinical trials for Importance of Vitamin D Therapy in Treatment of Neonatal Sepsis

Role of Vitamin D Therapy in Recovery From Early Neonatal Sepsis (Randomized Controlled Trial)

Start date: August 14, 2018
Phase: Phase 3
Study type: Interventional

Neonatal sepsis is still a major cause of morbidity and mortality despite major advances in neonatal intensive care units. Early-onset sepsis (EOS) is an infection of the blood acquired vertically from the mother and manifests shortly after birth. The objective of this study is to assess the vitamin D status in neonates with Early onset sepsis (EOS) and evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), in these infants.

NCT ID: NCT05969275 Recruiting - Sepsis Clinical Trials

Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

UC-CISSII
Start date: February 14, 2024
Phase: Phase 2
Study type: Interventional

Septic shock is associated with substantial burden in terms of both mortality and morbidity for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem (stromal) cells (MSCs) modulate inflammation, enhance pathogen clearance and tissue repair and reduce death. Our team has completed a Phase I dose escalation and safety clinical trial that evaluated MSCs in patients with septic shock. The Cellular Immunotherapy for Septic Shock Phase I (CISS) trial established that MSCs appear safe and that a randomized controlled trial (RCT) is feasible. Based on these data, the investigators have planned a phase II RCT (UC-CISS II) at several Canadian academic centres which will evaluate intermediate measures of clinical efficacy (primary outcome), as well as biomarkers, safety, clinical outcome measures, and a health economic analysis (secondary outcomes).

NCT ID: NCT05968287 Completed - Sepsis Clinical Trials

Can Measurement of Neutrophil-derived ROS Production be a Novel Biomarker of Sepsis?

LIT-sepsis
Start date: June 28, 2022
Phase:
Study type: Observational

Neutrophils are indispensable for host defense and have an important roles in modulating the immune system in both the innate and adaptive immune response. Neutrophils operate using a number of different mechanisms including chemotaxis, phagocytosis, release of reactive oxygen species (ROS) and granular proteins, and the production and liberation of cytokines for this purpose. A controlled neutrophil response is required to combat infection; an dysregulated state of this response can cause sepsis, tissue damage, and organ failure. Sepsis and septic shock are the leading causes of death especially in intensive care units (ICU), and their mortality can be reduced with prompt diagnosis and appropriate treatment modality. From this point of view, many biomarkers have been evaluated for the diagnosis, prognosis, and treatment response of infection and sepsis. An objective marker of cellular dysfunction of neutrophils would be a helpful tool for the clinician in detecting and monitoring changes related to infection status and to determine development of sepsis and positive effects of interventions.