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248 active trials for Sepsis

Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment

This study evaluates a novel arm restraint compared with traditional soft wrist restraints in older critically ill patients. The primary outcome is upper extremity mobility measured by actigraphy, and secondary outcomes include sedation, agitation, satisfaction, and acceptability.

Start: September 2019

Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care and Induced Frailty

The purpose of this study is to define the natural history and causes of chronic critical illness (CCI) in surgical intensive care patients who have had sepsis. The investigator wants to study a sub-population of sepsis patients that have intra-abdominal sepsis. The purpose of this research study is to define the acute changes in frailty (weakness, slowness, loss of muscle mass), comorbidity (medical problems) and disability (difficulty with mobility and performing routine daily functions) after having an infection that is located in the abdominal cavity or torso. The investigator believes having severe infection contributes to acute and permanent changes in these areas, especially in those of advanced age.

Start: April 2016

Study of Treatment's Echocardiographic Mechanisms

This ancillary study determines whether the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) [ClinicalTrials.gov Identifier: NCT03434028] treatment arms (restrictive fluids strategy vs. liberal fluid strategy) for early sepsis-induced hypotension are associated with differences in cardiac structure and function based on an echocardiogram at 24 hours after randomization. Secondarily, this ancillary study explores possible heterogeneity of treatment effect based on an echocardiogram performed shortly after randomization in CLOVERS.

Start: April 2019

Fosfomycin i.v. for Treatment of Severely Infected Patients

The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.

Start: December 2016

Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments

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?"

Start: April 2021

Prognostic Impact of Admission Glucose Level in Septic Patients Admitted to the Intensive Care Unit

Background: Sepsis is one of the most common reasons for admission to intensive care units (ICU) worldwide. About 30% of all patients admitted to intensive care suffer from sepsis (1). Sepsis causes an extreme physiological stress response, with significant changes in metabolism and disruption in glucose regulation. Disorder of glucose regulation can lead to hyperglycemia, hypoglycemia and glucose variability (2). All of these conditions are associated with increased mortality (3). In critically-ill patients, the glucose threshold from which damage may be caused remains controversial. Hyperglycemia often occurs in critically-ill patients suffering from sepsis, even in those who were not diabetic before, for several reasons. Sepsis causes massive activation of anti-inflammatory mediators which enhances the activity of counter-regulatory hormones, including cortisol, glucagon and catecholamines. Those hormones increase both hepatic gluconeogenesis and peripheral resistance to insulin (4). Some of the detrimental effects of hyperglycemia in septic patients are mediated via hyperglycemia-induced blood hypercoagulable state, decrease of vascular endothelial responsiveness and disrupted process of phagocytosis and chemotaxis of white blood cells, especially neutrophils (5). It is widely accepted that disordered blood glucose regulation increases mortality and morbidity, as well as hospital admission times and associated financial expenses (2,6). Blood glucose level at ICU admission was found to be a poor prognostic factor at various studies on different ICU patient populations (7-9). For example, in ICU patients admitted due to acute myocardial infarction, cardiogenic shock and need for urgent cardiac catheterization, high blood glucose levels at admission, even in non-diabetic patients, were associated with both increased in- hospital and long-term mortality (7). Among patients admitted due to acute heart failure, high admission glucose levels (above 200 mg / dL), in both diabetic and non-diabetic patients, were associated with higher mortality from cardio-vascular etiologies within one year of admission (8). Among non-diabetic patients admitted to the hospital due to acute myocardial infarction, admission glucose levels above 180 mg / dL were associated with a significant increase in all-causes in-hospital mortality (9). However, there is currently insufficient information regarding the prognostic impact of high admission glucose levels of non-diabetic septic patients admitted to the ICU (10).

Start: February 2021

Vitamin C Infusion for TReatment in Sepsis and Alcoholic Hepatitis

The purpose of this research study is to test the safety, tolerability, and effectiveness of Vitamin C (ascorbic acid) intravenous infusion when used to treat alcoholic hepatitis (inflammation of the liver from heavy alcohol use) and sepsis (life-threatening complication of an infection).

Start: April 2019

A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients

A phase II, multi-center (approximately 10 sites in Israel), randomized, placebo-controlled, dose- finding study comparing the efficacy, safety and tolerability of different dosing regimens of Allocetra-OTS, in up to 160 adult sepsis patients with organ sysfunction.

Start: November 2020

Monocyte Distribution Width (MDW) in Hospital Practice

Infections are an important cause of mortality and morbidity worldwide. Infections vary greatly in severity and can be caused by viruses, bacteria, fungi or protozoa. The rapid assessment of a patient to determine whether they have an infection and whether to treat with antibiotics is essential. Monocyte Distribution Width (MDW) is a (CE marked) new biomarker that has recently been studied in the emergency department (ED). This novel biomarker, which is currently available as a part of the panel of results from full blood count, holds the promise of reducing unnecessary antibiotic use and improving the outcome of patient's infections. Sepsis (blood poisoning) is a life-threatening condition that affects millions of people worldwide. The chance of dying from sepsis increases if there is a delay in treatment with the right antibiotics, but also using antibiotics incorrectly might lead to antibiotic resistance, which is dangerous for patients in the long term, as treatments might no longer work for them. An antibiotic is a substance produced naturally by microorganisms or synthetically by chemists in a laboratory. Antibiotics are capable of inhibiting the growth of or killing bacteria but are not effective against the viruses that cause many illnesses. The inappropriate use of antibiotics for these types of non-bacterial infections as well as the more frequent use of broad-spectrum antibiotics has caused the emergence of newer strains of bacteria that are resistant to many antibiotics. Rapid diagnostics are essential to accurately identify cases of sepsis that require antibiotic therapy; particularly since clinical criteria alone is often insufficient to avoid misclassifying patients with sepsis who require antibiotics. However, the high costs of current laboratory markers, along with the variable level of evidence supporting their use in sepsis and respiratory infections means that these are not in routine use. This study proposes to make use of data collected routinely at St. George's University Hospital to evaluate the accuracy of MDW as a marker for sepsis in adult patients admitted to the ED, as well as to explore its usefulness in supporting clinical decisions related to the discontinuation of antibiotic treatment in hospitalised adult patients. This observational study will not involve changes in patient management as all the data would be analysed retrospectively.

Start: July 2020

Sepsis Pre-Alert Monitoring Intervention: Study to Investigate Targeted Enhanced Monitoring for Sepsis

Sepsis is a leading cause of death worldwide, and contributes to approximately 750,000 hospitalizations per year, a third of which may die. International guidelines recommend timely interventions, including cultures, fluid resuscitation and antibiotics. Following guideline bundles is associated with a decrease in mortality. Key to timely intervention is timely diagnosis. Using the Epic sepsis predictive analytic tool, investigators will trigger vital sign and delirium monitoring in patients determined to be at increased risk for developing future sepsis. The primary objective of this study is to demonstrate reduced mortality in patients for whom the pre-sepsis algorithm threshold is met, and who enhanced monitoring.

Start: September 2021

Tumescent Anesthesia Antibiotic Delivery (TAAD)

This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic delivery: Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food & Drug Administration (FDA) has approved our Investigational New Drug (IND) application to conduct this RCT. An IND application was necessary because subcutaneous injection of antibiotics in general, and cefazolin and metronidazole in particular are considered to be "off-label". In addition, the tumescent formulation of cefazolin (1gm) and metronidazole (500mg/100ml) in a dilute solution of lidocaine (1gm), epinephrine (1mg) in 100ml and sodium bicarbonate (10mEq/10ml) added a 1000ml bag of 0.9% sodium chloride (total volume 1210ml) is also considered "off-label." This trial will also prospectively study the HK Surgical SubQKath, an over-the-needle subcutaneous catheter specifically designed to deliver relatively large volumes of a relatively dilute TAAD solution. The TAAD trial will document the safety and efficacy of the HK SubQKath

Start: December 2021

Evaluation of Infection in Obstructing Urolithiasis

Obstructing urolithiasis can be life-threatening in the setting of urinary tract infection. The purpose of this study is to identify and validate risk factors and markers for the presence of infection and development of sepsis among patients with obstructing urolithiasis.

Start: September 2019

Immune Homeostasis in Sepsis and Septic Shock

Detailed description of immune response and its dynamics in sepsis and septic shock patiens by means of transcriptomics, flow-cytometry and cytokine analysis.

Start: September 2019

Genomics in Infection and Sepsis to Predict Organ Dysfunction and Outcomes in Sepsis

This is a prospective cohort study using gene expression to study patients with infection and sepsis from pneumonia.

Start: December 2019

Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS

This study investigates the mechanism by which kidney dysfunction perpetuates inflammation, immunosuppression, and catabolism (PICS) in chronic critical illness. The investigators will test the hypothesis that persistent kidney dysfunction in sepsis associated by chronic critical illness contributes to decreased survival through the development of PICS. In chronic critical illness, the persistence of the inflammatory state may lead to capillary rarefication in the kidney causing accelerated chronic kidney disease. Progression of chronic kidney disease during chronic critical illness can drive PICS. Indeed, many of the features of chronic critical illness are consistent with the protein-energy malnutrition and muscle wasting associated with chronic kidney disease. Thus, the kidney can play a contributory role in chronic critical illness and PICS.

Start: February 2015

Sidestream Dark-Field (SDF) Imaging of the Intestinal Microcirculation

Sepsis is the most frequent cause of death in critically ill patients in non-coronary care Intensive Care Units in the developed world. Microcirculatory disturbances are central to the development of the disorder, leading to organ dysfunction, multi-organ failure and fatal outcome. In particular the intestinal microcirculation is impaired early in the course of the disease. This may result in a breakdown of the gut barrier function with translocation of bacteria and their toxins into the systemic circulation, thus sustaining a "gut derived" septic state. Therefore, the impaired intestinal microcirculation has been suggested to act as the "motor of multiple organ failure" in sepsis. The aim of the project is to evaluate a new diagnostic tool and the impact of Activated Protein C administration on the intestinal microcirculation in patients with severe sepsis and compare the findings with septic patients who are not candidates for APC therapy and healthy patients post bowel surgery using an innovative diagnostic tool (side stream dark-field imaging, SDF).

Start: November 2011

Human Milk Fortification in Extremely Preterm Infants

This is a randomised controlled multi-centre trial comparing the effect of diet supplementation of a human breast milk-based nutrient fortifier (H2MF®) with standard bovine protein-based nutrient fortifier in 222 extremely preterm infants (born before gestational week 28+0) exclusively fed with human breast milk (own mother´s milk and/or donor milk). The infants will be randomised to receive either the human breast-milk based H2MF® or the standard bovine protein-based nutrient fortifier when oral feeds have reached <100 ml/kg/day. The randomised intervention, stratified by centre, will continue until the target gestational week 34+0. The infant must not be fed with formula during the intervention period. The allocation will be concealed before inclusion, but after randomisation the study is not blinded. Primary endpoint of the intervention is the composite variable necrotizing enterocolitis (NEC), sepsis and mortality. The enrolled infants are characterised with clinical data including growth, feeding intolerance, use of enteral and parenteral nutrition, treatment, antibiotics and complications collected daily in a study specific case report form from birth until discharge from the hospital (not longer than gestational week 44+0). A follow up focusing on neurological development, growth and feeding problems will be performed at 2 years of age (corrected) and 5.5 years of age.

Start: February 2019

Anti-inflammatory Action of Oral Clarithromycin in Community-acquired Pneumonia

Traditional management of community-acquired pneumonia (CAP) relies on the prompt administration of antimicrobials that target the most common causative pathogens. Retrospective analysis of observational clinical studies in CAP showed that the addition of macrolides to standard antibiotic therapy conferred a significant survival benefit. The proposed benefit of macrolides is coming from their anti-inflammatory mode of action. An RCT that proves the attenuation of the high inflammatory burden of the host with CAP after addition of clarithromycin in the treatment regimen is missing. This RCT is aiming to prove that addition of oral clarithromycin to a ?-lactam rapidly attenuates the high inflammatory burden of the host in CAP.

Start: January 2021

Effect of Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis

The occurrence of sepsis in trauma patients is a very serious complication. Identifying trauma patients at high risk of sepsis was not revealed in the latest surviving sepsis campaign in 2016. Several biomarkers have been proposed for early prediction of sepsis in trauma patients as leukocyte anti sedimentation rate (LAR) and the proinflammatory cytokine monocyte chemo attractant protein-1 (MCP-1). Sepsis prophylaxis before occurrence of multi-organ failure still represents a major challenge. Vitamin D and probiotics have antimicrobial, anti-inflammatory and gut microbiota immune modulatory properties.Little is known about the effect of vitamin D and probiotics co-supplementation on the inflammatory response in trauma patients at high risk of sepsis. Another promising strategy is the use of vitamin C in addition to thiamine. Trauma is associated with increased oxidative stress and vitamin C deficiency. High dose vitamin C is required to restore oxidant-antioxidant balance. Vitamin C and thiamine have shown promising results in treatment of sepsis. Vitamin C possesses anti-inflammatory, endothelial protective and anti-microbial effects. Thiamine is the precursor of thiamine pyrophosphate (TPP), a key enzyme in Krebs cycle.

Start: February 2020

Analysis of the Coagulopathy Developed by COVID-19 Infected Patients

Increased D-dimers at admission of COVID-19 infected patients entering hospital due to a severe disease is a risk factor for death. Understanding this acquired coagulopathy is a prerequisite before specific interventional studies. The study investigators aim to apply a normalized and automated thrombin generation test (TGT), developed for testing the thrombotic risk (triggered by 5 pM Tissue Factor, with a purified thrombomodulin (TM) challenge) and to study its association with survival.

Start: April 2020