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Sepsis clinical trials

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NCT ID: NCT05507957 Not yet recruiting - Sepsis Clinical Trials

Impact of Blood Culture Positivity Time on Clinical Management of Pediatric ICU Patients

Start date: January 1, 2023
Phase:
Study type: Observational

Sepsis accounts for high morbidity and mortality rates in ICU globally. Early recognition of sepsis with appropriate antimicrobial therapy is critical for the appropriate management of patients (1). Blood culture (BC) is considered the gold standard for sepsis etiological diagnosis , with good sensitivity ,but suffering usually of delay or even failure to detect microorganisms in patients already treated with antimicrobials and failure to identify pathogens other than bacteria or yeast (2, 3). Time-to-positivity (TTP) of blood cultures is defined as the time from the start of incubation to a positive signal. Knowledge of the distribution of blood culture TTP is of clinical benefit in the re-evaluation of patients with a clinical syndrome consistent with infection. A low probability of bacteremia when blood cultures have remained negative after 24 hours (4). Positive episodes with TTP more than or equal 24 h are commonly optimally treated infections, catheter-related infections, or infections caused by slowly growing microorganisms such as Candida or anaerobic Gram-negative bacteria. Growth of multidrug-resistant Gram-negative bacilli is exceptional beyond 24 h. In current clinical practice, bacteremia is considered unlikely if blood cultures have been negative for 48-72 hours (5, 6). Most blood culture bottles turn positive in less than 4 days, shortening the duration of incubation appears the most relevant solution in order to free additional capacity(4). Various disinfectants, such as povidone iodine (PVI), alcohol preparations, and chlorhexidine gluconate ethanol (CHG-ALC), are used for disinfection prior to blood culture sampling. Contamination rates of cultured blood samples vary according to the disinfectant used, sampling site, definition of contamination, and skill level of individuals performing the venipuncture.(7, 8) In this study, Investigators assessed the real life clinical impact on septic ICU patients based on time of blood culture positivity time.

NCT ID: NCT05507437 Completed - Clinical trials for Acute Kidney Injury Due to Sepsis

Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury

Start date: November 22, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).

NCT ID: NCT05502107 Recruiting - Sepsis Clinical Trials

Impact of a Prehospital Sepsis Protocol on Timely Antibiotic Administration and Subsequent Adverse Events

IMPRESS
Start date: June 27, 2023
Phase: N/A
Study type: Interventional

The primary purpose of this study is to evaluate the impact of an Emergency Medical Services (EMS) based sepsis screening and early warning protocol on the timing of early sepsis care in the Emergency Department (ED).

NCT ID: NCT05496816 Completed - Sepsis Clinical Trials

Coagulation Disturbances in COVID-19 Septic Patients

Start date: January 1, 2021
Phase:
Study type: Observational

Objective of this study was to determine the relationship between CAC and septic condition in COVID-19 critically ill patients. Data including age, sex, comorbidities, quick Sequential Organ Failure Assessment (qSOFA) score, vasopressors requirement, laboratory findings: platelets, neutrophils, lymphocytes, procalcitonin (PCT), C-reactive protein (CRP), fibrinogen, D-dimer, sepsis-induced coagulopathy (SIC) and disseminated intravascular coagulation (DIC) score were recorded on the day of admission and on the day of starting of invasive mechanical ventilation. Primary outcome was to establish CAC with sepsis; secondary outcome measure was incidence of CAC in sepsis and septic shock in COVID-19 critically ill patients.

NCT ID: NCT05495607 Completed - Sepsis Clinical Trials

Continous Renal Replacement Therapy With the CARPEDIEM® in a French National Cohort of 25 Neonates and Small Infants

Start date: December 1, 2018
Phase:
Study type: Observational

Historically, CKRT and hemodialysis were performed in small infants and newborns with devices developed for adults with high rates of complications and mortality. We aim to retrospectively report the first multicenter French experience of CARPEDIEM® use and evaluate the efficacy, feasibility, outcomes, and technical considerations of this new device in a population of neonates and small infant. Compared to adult's device continuous renal replacement therapy with an adapted machine allowed successful blood purification without severe complications even in low birth weight neonates.

NCT ID: NCT05495438 Completed - Sepsis Clinical Trials

Impact and Safety of AI in Decision Making in the ICU: a Simulation Experiment

ICU
Start date: July 22, 2022
Phase:
Study type: Observational

The impact of deploying artificial intelligence (AI) in healthcare settings in unclear, in particular with regards to how it will influence human decision makers. Previous research demonstrated that AI alerts were frequently ignored (Kamal et al., 2020 ) or could lead to unexpected behaviour with worsening of patient outcomes (Wilson et al., 2021 ). On the other hand, excessive confidence and trust placed in the AI could have several adverse consequences including ability to detect harmful AI decisions, leading to patient harm as well as human deskilling. Some of these aspects relate to automation bias. In this simulation study, the investigators intend to measure whether medical decisions in areas of high clinical uncertainty are modified by the use of an AI-based clinical decision support tool. How the dose of intravenous fluids (IVF) and vasopressors administered by doctors in adult patients with sepsis (severe infection with organ failure) in the ICU), changes as a result of disclosing the doses suggested by a hypothetical AI will be measured. The area of sepsis resuscitation is poorly codified, with high uncertainty leading to high variability in practice. This study will not specifically mention the AI Clinician (Komorowski et al., 2018). Instead, the investigators will describe a hypothetical AI for which there is some evidence of effectiveness on retrospective data in another clinical setting (e.g. a model that was retrospectively validated using data from a different country than the source data used for model training) but no prospective evidence of effectiveness or safety. As such, it is possible for this hypothetical AI to provide unsafe suggestions. The investigators will intentionally introduce unsafe AI suggestions (in random order), to measure the sensitivity of our participants at detecting these.

NCT ID: NCT05491941 Recruiting - Septic Shock Clinical Trials

Assessment for Implementation Methods in Sepsis

AIMS
Start date: July 15, 2022
Phase: N/A
Study type: Interventional

Since the introduction of sepsis bundles, there have been multiple published trials that have demonstrated a consistent, strong association between implementation of sepsis "bundles" (3-hour bundle) and improved survival. The current proposal is a Hybrid 2, pragmatic, cluster randomized clinical effectiveness/implementation trial evaluating mortality and respiratory failure-based outcomes, in patients admitted to the emergency department with sepsis, comparing the effectiveness of implementation of the hour-1 bundle to 3-hour bundle, while facilitating adherence to both bundles. In addition, 4 distinct sepsis phenotypes will be derived from routine clinical data to identify specific patient phenotypes that allow for a more precision-based application of sepsis bundles in future studies.

NCT ID: NCT05490498 Recruiting - Neonatal Sepsis Clinical Trials

Study of the Breast Milk Microbiota and Its Influence on the Development of Early and Late Neonatal Bacterial Sepsis Under Three Months of Age.

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

Breast milk contains many microorganisms including bacteria that are beneficial to health (probiotics), but also bacteria that are generally considered pathogenic. Several studies have described an increased risk of infections due to pathogenic germs in breast milk in premature newborns whose digestive system is immature and whose digestive flora is modified by repeated antibiotic treatments. However, a breastfed baby is better protected against infectious diseases than a bottle-fed baby. The objective of this study is to define the breast milk microbiota of infants with confirmed early or late neonatal bacterial infection compared to the breast milk microbiota of infants with no evidence of bacterial infection. For that purpose, an exploration will be performed using the principle of "Microbial Culturomics" and targeted metagenomics (16S ribosomal RNA gene sequencing).

NCT ID: NCT05490212 Recruiting - Infection; Newborn Clinical Trials

Salivary Profiling in Infants Treated for Suspected Sepsis: The SPITSS Study

SPITSS
Start date: October 3, 2019
Phase:
Study type: Observational

The aim of this study is to develop a faster, safer, and more accurate method for determining if a newborn has an infection. This study involves analyzing saliva for markers of infection and inflammation known as cytokines. We will analyze infant's saliva repeatedly for inflammatory biomarkers (cytokines) within the first 36 hours of their standard of care treatment. We hypothesize that levels of these cytokines will more quickly predict which babies are truly infected and which babies are not compared to the blood tests currently being used.

NCT ID: NCT05485051 Completed - Clinical trials for Ventilator Associated Pneumonia

Daily Chlorexidine Bath for Health Care Associated Infection Prevention

CLEAN-IT
Start date: August 3, 2022
Phase: Phase 3
Study type: Interventional

Cluster randomized controlled trial comparing two bathing strategies in critically ill patients. The intervention group will receive daily bathing with chlorhexidine. The control group will receive usual care.