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248 active trials for Sepsis

Vitamin C & Thiamine in Sepsis

Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.

Start: September 2018

Early Identification and Effective Management of Pediatric Sepsis

In patients diagnosed as sepsis on PICU admission, early and accurate identification of patients who will develop organ dysfunction (severe sepsis) is critical for effective management and positive outcome. A multiple marker approach would improve clinical utility compared with use of a single marker. The primary goal of this part of study is to define a combination of multiple markers, derived from novel biomarkers (nCD-64, IL-27, sTREM, HLA-DR, IL-10), metabolomics and routine clinical parameters, which could predict severe sepsis and determine the severity of disease.

Start: October 2018

Assessing the Effects of CytoSorb Hemoperfusion on the Development on Immunoparalysis

In this randomized, open-label study, the investigators will assess whether CytoSorb hemoperfusion will prevent or attenuate the development of immunoparalysis in healthy volunteers undergoing repeated experimental endotoxemia.

Start: September 2020

Clinical Features and Outcomes of CBP Versus Non-CBP in Septic Children

The effect of continuous blood purification (CBP) in children is unclear. Also, the timing of early application is still being explored. In this study, we need to explore the efficacy and the timing of application of CBP in children with sepsis or septic shock.

Start: December 2018

Preoperative High-dose Dexamethasone and Emergency Laparotomy

The aim of this trial is to evaluate the effect of high-dose glucocorticoid on inflammatory response and recovery after emergency laparotomy in participants with intestinal obstruction and perforated viscus. Primary outcome is the reduction of C-reactive protein on postoperative day 1. Secondary outcomes are organ specific complications in the post anaesthesia phase, endothel and inflammatory markers, fluid status, preload dependency, pain, lung function, nausea and mobilization during the first 5 days after surgery, . The investigators hypothesize, that a preoperative single high dose of glucocorticoid reduces systemic inflammatory response after emergency laparotomy.

Start: March 2021

INFLAmmasomes NLRP3 in Platelets and Leukocytes During SEPSIS in Intensive Care Unit

septic shock is the first cause of mortality in intensive care unit. Innate immunity is the body's first line of defense against pathogens

Start: July 2020

Molecular Biomarkers for Sepsis

This multi-center observational case-control study in Intensive Care Unit (ICU) patients is to identify novel biomarkers allowing to recognize severe community acquired pneumonia (sCAP) -associated sepsis at an earlier stage and predict sepsis-related mortality. Patients with sCAP (cases) will be profoundly characterized over time regarding the development of sepsis and compared with control patients. The mechanisms and influencing factors on the clinical course will be explored with most modern -omics technologies allowing a detailed characterisation. These data will be analysed using machine learning algorithms and multi-dimensional mathematical models.

Start: July 2021

Randomized Pilot Study Evaluating the Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care.

Sepsis is one of the leading causes of death in intensive care. About 50% of patients with septic shock die after 1 year; and 50% of survivors suffer from cognitive decline (Singer et al., 2016). The pathophysiological mechanisms of serious complications of sepsis are now well known. In fact, the systemic inflammation related to sepsis amplifies the release of pro-inflammatory cytokines and neurotoxic mediators, hence an increase in deleterious phenomena such as oxidative stress, mitochondrial dysfunction, endothelial activation, disruption of the blood-brain barrier, neuroinflammation (astrocytic and microglial activation) leading to multi-organ failure which compromises the patient's vital and functional prognosis (Eidelman et al., 1996, Annane and Sharshar, 2015). Although there has been progress in the understanding of its pathophysiology, the management of sepsis and septic shock in intensive care relies mainly on anti-infective treatments and the restoration of cardiovascular and respiratory functions (Dellinger et al., 2013). There is virtually no adjuvant therapy for the management of sepsis (Annane, 2016a, Annane et al., 2016), apart from a few hormonal therapies such as insulin to maintain blood glucose levels below 180 mg / dL and low doses of corticosteroids and vasopressin. There is therefore a pressing need to develop innovative treatments targeting inflammatory and immunological processes in order to reduce the complications of sepsis and improve patient prognosis. Some recent work has shown that electrical vagus nerve stimulation (SNV), a technique used for the treatment of drug-resistant epilepsy, can modulate inflammatory and immune responses and control inflammation syndrome in animal models of sepsis, arthritis and rheumatism in humans (Meneses et al., 2016; Koopman et al., 2016). In this pilot study we plan to evaluate the efficacy of transcutaneous (non-invasive) SNV as an adjuvant treatment in patients with sepsis in intensive care.

Start: February 2021

The Effect of REcombinant Human Thrombopoietin (rhTPO) on Sepsis Patients With aCUte Severe thrombocytopEnia

The purpose of this study is to determine whether recombinant human thrombopoietin(rhTPO) can rapidly increase the platelets counts, shorten the time of the platelet returned to normal, reduce platelet transfusion and bleeding events, prompt recovery of organ function, decrease the length of ICU stay, and eventually reduce the 28-day mortality in sepsis patients with severe thrombocytopenia.

Start: April 2019

A Machine Learning Predictive Model for Sepsis

Timely and accurately predicting the occurrence of sepsis and actively intervening in treatment may effectively improve the survival and cure rate of patients with sepsis. Using machine learning and natural language processing, we want to develop models to 1) identify all children with sepsis admitted to hospital and 2) stratify them to distinguish those who are at high risk of death b) How will you undertake your work? From Shanghai hospitals anf MIMIC III, we will develop a very large dataset of patient admissions for all medical conditions including sepsis from the electronic health record. This data will include both structured data such as age, gender, medications, laboratory values, co-morbidities as well as unstructured data such as discharge summaries and physician notes. Using the dataset, we will train a model through natural language processing and machine learning to be able to identify people admitted with sepsis and identify those patients who will be at high risk of death. We will test the ability of these models to determine our predictive accuracies. We will then test these models at other institutions.

Start: April 2019

Role of Active Deresuscitation After Resuscitation-2

RADAR-2 will be a randomised, open-label, allocation concealed, pilot trial of conservative fluid administration and deresuscitation compared with usual care in patients who are critically ill.

Start: April 2018

Short-course Antimicrobial Therapy in Sepsis

The purpose of this study is to compare the effect of a short course antimicrobial therapy (5-days) versus a 10-days therapy on sepsis-related organ dysfunction.

Start: September 2016

Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?

The aim of this project is to test the utility of The Gene Z device (as of 2018 Gene Z no longer being used) and other rapid identification techniques that the investigators have developed in the lab on clinically obtained bodily fluid samples taken from patients with suspected infection or sepsis based on having three of four positive Systemic Inflammatory Response Syndrome markers, or having a known infection for which a specimen is being collected. Specimens will be collected by Sparrow Laboratories and McLaren Greater Lansing laboratories, processed and stored for analysis at a later date to determine if the microbial pathogens identified by current methods of culture, as well as pathogen susceptibility to antibiotics by culture results, can be identified by the GeneZ technology or other developed technology accurately, and more timely. It will not affect current patient care nor impact patient care, which will continue in the standard fashion today for sepsis. Results will be compared to standard culture results and antibiotic sensitivities.

Start: June 2015

Procalcitonin and Antimicrobial Utilization in Critically Ill Cancer Patients With Sepsis

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.

Start: August 2019

Bolus Versus Continuous Enteral Tube Feeding

Stress metabolisms induced by severe trauma, large abdominal surgery procedures, sepsis, etc. leads to metabolic changes, which increase energy expenditure, enhanced protein catabolism, insulin resistance. Muscle proteolysis is massively stimulated. Critically ill patients pay for survival with a loss of muscles. Enteral nutrition, especially protein delivery to critically ill, is very important for optimizing their outcome. Standard enteral feeding regiments are generally based on continuous feeding, which is thought to be better tolerated by critically ill patients with easier glycaemic control by continuous infusion of insulin, translated in less glycaemic variability. But this approach is not physiological, continuous feeding does not allow protein synthesis. Optimal protein synthesis requires a pulsatile increase in branched-chain amino acids. Bolus feeding activates the entrohormonal axis (bioactive peptides, insulin), and stimulates skeletal muscle synthesis to the maximum extent. The question is, whether bolus enteral feeding in critically ill patients with limited gastrointestinal function delivers a greater amount of protein, improves nutritional parameters, with higher quadriceps muscle layer thickness (QMLT) and muscle strength.

Start: October 2019

A Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis)

Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI. Two urinary biomarkers have been identified as early indicators of AKI. The NephroCheck® test is a commercially available test that uses these biomarkers, and this study assesses the use of these in reducing negative clinical outcomes for patients with sepsis-associated AKI. The study will enroll subjects diagnosed with sepsis, including septic shock, who will be randomly assigned to either receive NephroCheck®-guided kidney-sparing and fast-tracking interventions; or to receive current Standard of Care assessment and treatment.

Start: January 2021

Metabolomics and Microbiomics in Cardiovascular Diseases

"MEtabolomics and MicrObiomics in caRdIovAscular diseases Mannheim (MEMORIAM) " is a single-center, prospective and observational study investigating to identify disease-specific metabolic, respectively microbiomic, patterns of patients with high-risk cardiovascular diseases. High-risk cardiovascular diseases comprise patients suffering from acute heart failure (AHF), ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), sepsis, septic shock, ischemic and non-ischemic cardiomyopathy.

Start: February 2019

Provider Perspectives on Beta-lactam Therapeutic Drug Monitoring Programs in the Critically Ill

The purpose of the study is to characterize various healthcare practitioners' perspectives on implementation of beta-lactam therapeutic drug monitoring in critical care practice.

Start: October 2020

Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance

Critically ill patients with sepsis undergo several physiological alterations that can alter the distribution, metabolism, and elimination of drugs. Some patients with sepsis may realize enhanced cardiac output leading to increases in glomerular filtration that result in increasing drug clearance. This clinical state is referred as Augmented Renal Clearance (ARC). Importantly, many beta-lactam antibiotics can be adversely affected by ARC, and some of these agents required increasing dosage to compensate for enhanced clearance. Imipenem-relebactam is a new broad spectrum antibiotic. This study is designed to assess the pharmacokinetics of both components, imipenem and relebactam, in critically ill patients with ARC.

Start: February 2020

Imipenem/Cilastatin/Relebactam PK in ECMO

Extracorporeal membrane oxygenation (ECMO) is a from of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and re-infused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, imipenem-cilastatin-relebactam, in critically ill patients receiving ECMO.

Start: January 2021