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Sepsis clinical trials

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NCT ID: NCT05208112 Completed - Sepsis Clinical Trials

Intravenously Administered M6229 in Critically Ill Sepsis Patients

HistoSeps
Start date: April 5, 2022
Phase: Phase 1
Study type: Interventional

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Mortality is high and survivors frequently suffer from long-term sequelae. Extracellular histones have been identified as essential mediators in the pathogenesis of sepsis and septic shock. These toxic molecules are released by damaged cells in response to infection and high extracellular levels can induce tissue injury and multiple organ dysfunction syndrome. Extracellular histones can be neutralized by complexation with the new candidate drug called M6229, a non-anticoagulant heparin, allowing the use of elevated dose levels relative to regular unfractionated heparin. This project aims at the roll-out of a first-in-man clinical study in sepsis patients evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effects of intravenously administered M6229 in subjects suffering from sepsis.

NCT ID: NCT05172479 Completed - Sepsis Clinical Trials

Prognostic Accuracy of qSOFA, SIRS, and EWSs for In-hospital Mortality in Emergency Department

PASSEM
Start date: December 12, 2021
Phase:
Study type: Observational

Early identification of a patient with infection who may develop sepsis is of utmost importance. Unfortunately, this remains elusive because no single clinical measure or test can reflect complex pathophysiological changes in patients with sepsis. However, multiple clinical and laboratory parameters indicate impending sepsis and organ dysfunction. Screening tools using these parameters can help identify the condition, such as SIRS, quick SOFA (qSOFA), National Early Warning Score (NEWS), or Modified Early Warning Score (MEWS). The 2016 SCCM/ESICM task force recommended using qSOFA, while the 2021 Surviving Sepsis Campaign strongly recommended against its use compared with SIRS, NEWS, or MEWS as a single screening tool for sepsis or septic shock. We hypothesised that qSOFA has greater prognostic accuracy than SIRS and EWS (NEWS/NEWS2/MEWS).

NCT ID: NCT05143645 Completed - Sepsis Clinical Trials

A New Protocol for Continuous Vancomycin Infusion Dosing.

CVIP
Start date: September 1, 2013
Phase:
Study type: Observational

This observational study prospectively collect data on chosen dosing, renal function, measured plasma concentrations and adherence to the recommended clinical protocl for ICU patients treated with continuous vancomycin infusion.

NCT ID: NCT05140213 Completed - Sepsis Clinical Trials

A STUDY BEFORE/AFTER THE IMPLEMENTATION OF AN ANTI-INFECTIOUS PRESCRIPTION AID

Start date: December 12, 2020
Phase:
Study type: Observational

Anti-infective strategy is a major public health problem. This is a before-and-after study of an anti-infectious prescription tool with a comparison of mortality at 30 days (then 3 and 6 months) between the two inclusion phases of 6 months each.

NCT ID: NCT05139459 Completed - Sepsis Clinical Trials

Sepsis Characterization in Kilimanjaro

SICK
Start date: January 17, 2022
Phase:
Study type: Observational

The aim of this study is to prospectively evaluate the barriers to care, evaluation, clinical practices, and outcomes for patients presenting with sepsis to hospitals in the Kilimanjaro Region of northern Tanzania. This will include an assessment of timing and selection of antimicrobials and administration and volume of intravenous fluids. The study also aims to characterize sepsis sub-types in the epidemiologic context of northern Tanzania using statistical clustering techniques of clinical variables and of host immune response patterns.

NCT ID: NCT05095220 Completed - Sepsis Clinical Trials

Integration of NAVOY® Sepsis in an Electronic Health Record System

GENIUS
Start date: May 27, 2022
Phase:
Study type: Observational

The study aims to evaluate the performance of NAVOY® Sepsis in predicting the sepsis risk in adult ICU patients. Data collection is performed via automatic retrieval from the electronic health record system to AlgoDx proprietary cloud service where it is analysed in a simulated environment.

NCT ID: NCT05094856 Completed - Sepsis Clinical Trials

Effects of Fluid Therapy on Peripheral TIssse Perfusion During Sepsis/Septic Shock

REPTILOS
Start date: February 23, 2022
Phase:
Study type: Observational

Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1

NCT ID: NCT05094154 Completed - Sepsis Clinical Trials

Effect of Antibiotic Choice On ReNal Outcomes (ACORN)

ACORN
Start date: November 10, 2021
Phase: Phase 4
Study type: Interventional

Sepsis is one of the most common causes of acute illness and death in the United States. Early, empiric broad-spectrum antibiotics are a mainstay of sepsis treatment. Two classes of antibiotics with activity against Pseudomonas, anti-pseudomonal cephalosporins and anti-pseudomonal penicillins, are commonly used for acutely ill adults with sepsis in current practice. Recent observational studies, however, have raised concern that anti-pseudomonal penicillins may cause renal toxicity. Anti-pseudomonal cephalosporins, by comparison, may be associated with a risk of neurotoxicity. Rigorous, prospective data regarding the comparative effectiveness and toxicity of these two classes of medications among acutely ill patients are lacking. The investigator propose a randomized trial comparing the impact of anti-pseudomonal cephalosporins and anti-pseudomonal penicillins on renal outcomes of acutely ill patients.

NCT ID: NCT05076721 Completed - Sepsis Clinical Trials

Effectiveness of Simulation Based Training in Implementing One Hour Bundle Sepsis

Start date: August 22, 2020
Phase: N/A
Study type: Interventional

This study aimed to compare simulation training with conventional training (case-based discussion only) to improve team performance in implementing one-hour sepsis bundle in the intensive care unit

NCT ID: NCT05076435 Completed - Sepsis Clinical Trials

Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients

REFACED Sepsis
Start date: November 3, 2021
Phase: Phase 2
Study type: Interventional

This is an investigator-initiated, multicenter, randomized, parallel-group, open-labeled, feasibility trial investigating volumes of fluid within 24 hours in 124 patients with sepsis allocated to two different IV fluid regimens enrolled at three emergency departments in Central Region Denmark. The primary outcome is total intravenous, crystalloid fluid volume within 24 hours and key secondary outcomes include protocol violations, total fluids (intravenous and oral) within 24 hours, SAEs/SUSARs, and inhospital-, 30- and 90-day mortality.