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Sepsis clinical trials

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NCT ID: NCT05770622 Not yet recruiting - Sepsis Clinical Trials

Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)

VANCAPP
Start date: August 2024
Phase: Phase 4
Study type: Interventional

A challenge to intermittent vancomycin dosing in young infants is the avoidable delay caused by the need to wait until steady state (i.e. when the drug concentrations are in equilibrium) to measure a vancomycin concentration, as this generally occurs 24 to 48 hours after starting treatment. If the target concentration is not achieved, the dose needs to be adjusted, resulting in further delays in an infant achieving the concentration required to treat their infection. The purpose of this study is to assess the use of early therapeutic drug monitoring (first-dose trough) and, if needed, early dose adjustment, in achieving target vancomycin concentrations at steady state. A dose adjustment calculator (available through a web application) will be used to determine the need for dose adjustment (based on predicted steady state concentration) and recommend an adjusted dose if required.

NCT ID: NCT05763680 Recruiting - Clinical trials for Microbial Colonization

Molecular Culture for the Diagnosis of Neonatal Sepsis

Start date: July 15, 2023
Phase:
Study type: Observational

Rationale: Early diagnosis of sepsis in neonates is complicated as the signs and symptoms are nonspecific. Although blood culture is the gold standard for the diagnosis, false-negative results and long incubation period of 36-72 hours limits the use of blood culture to rule out sepsis at initial suspicion. Since delay in diagnosis may lead to progressive deterioration, antibiotics are often started empirically at initial sepsis suspicion, awaiting results of the blood culture. Consequently, uninfected infants are often unnecessarily exposed to empirical antibiotics. To reduce unnecessary treatment of non-infected infants, an early, sensitive and specific diagnostic tool would be helpful to guide clinicians faster when to discontinue antibiotics. Molecular Culture (MC) via IS-pro is a novel, advanced, molecular culture technique which is able to culture bacteria within 4 hours after blood sampling. MC might thus be a potential diagnostic tool to detect or rule out sepsis in infants quickly, however data on MC for diagnosis of sepsis in this population is limited. Objective: The aim of this study is to evaluate whether MC is of additive predictive value for the diagnosis sepsis in this vulnerable group. Study design: Prospective observational cohort study. Study population: All infants suspected for neonatal sepsis of both early and late onset will be eligible for study participation. They will be treated according to the standard local guidelines. Intervention (if applicable): In case of a suspicion of sepsis at birth, blood will be collected for a conventional blood culture as part of standard care. Additionally, a blood sample will be collected from the umbilical cord for MC. In case of a suspicion of sepsis not directly postpartum, an additional blood sample will be taken for MC analysis, directly following sampling for conventional culture, implying no extra phlebotomy. Main study parameters/endpoints: The main study parameter is the discordance in positive and negative outcomes of MC compared to outcomes of conventional blood culture. As the diagnostic accuracy of the conventional blood culture (the current gold standard) is being questioned, the predictive value of MC versus conventional blood culture towards clinical sepsis will also be tested.

NCT ID: NCT05759494 Not yet recruiting - Sepsis Clinical Trials

The Clinical and Pharmacoeconomic Impact of Rapid Diagnostic Test (Multiplex PCR FilmArray) on Antimicrobial Decision Making Compared to Conventional Decision Making Among Critically Ill Patients

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

We will show in this study the impact of use the rapid diagnostic method (multiplex PCR filmArray) on clinical and pharmacoeconomic aspects among Critically Ill Patients.

NCT ID: NCT05758246 Recruiting - Sepsis Clinical Trials

Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial

Start date: August 23, 2023
Phase: Phase 2
Study type: Interventional

The long-term goal is to test the clinical efficacy of senolytic therapies to reduce progression to and severity of sepsis in older patients. The central hypothesis is that a threshold burden of SnCs predisposes to a SASP mediated dysfunctional response to PAMPs, contributing to a disproportionate burden of sepsis in older patients. The study hypothesizes timely treatment with fisetin will interrupt this pathway. A multicenter, randomized, adaptive allocation clinical trial to identify the most efficacious dose of the senolytic fisetin to reduce the composite cardiovascular, respiratory, and renal sequential organ failure assessment score at 1 week, and predict the probability of success of a definitive phase III clinical trial.

NCT ID: NCT05755503 Recruiting - Pharmacokinetics Clinical Trials

Toxicokinetics of Protein-bound Uremic Toxins in ESRD Patients

Start date: February 21, 2023
Phase:
Study type: Observational

Protein-bound uremic toxins (PBUTs) are important uremic toxins, represented by indoxyl sulfate (IS), derived from the fermentation of dietary proteins by gut bacteria. The purpose of this study was to study the changes of IS in maintenance hemodialysis patients, and to construct a metabolic kinetics model of IS clearance. The model was then used to estimate the clearance rate of indoxyl sulfate by hemoperage, and to verify the application value of the model. This study intends to collect a series of serum, dialysate and urine samples from maintenance hemodialysis patients receiving high-throughput dialysis or hemodialysis filtration, so as to clarify the variation rule of IS during various blood purification treatments. Furthermore, a three-compartment model of dialysis IS metabolism kinetics was constructed according to the IS clearance of dialysis and residual kidney, and the above model was verified internally and externally. Finally, the model's fit and predictive value were validated in a group of MHD patients treated with HP without residual kidney.

NCT ID: NCT05748301 Not yet recruiting - Sepsis Clinical Trials

AI Clinician XP2 - A Study of the AI Clinician Running in Real Time in the ICU

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

The cornerstone of sepsis resuscitation is the administration of intravenous fluids (IVF) and/or vasopressors (drugs that squeeze the blood vessels to increase blood pressure) to maintain blood flow to prevent organ failure. However, there is huge uncertainty around the individual dosing of these drugs in an individual patient, partially due to high sepsis heterogeneity. The current guidelines provide recommendations at a population-level but fail to individualise the decisions. Wrong decisions lead to poorer outcomes and increased ICU-resource use. A tool to personalise these medications could improve patient survival. The investigators have developed a new method to automatically and continuously review and recommend the correct dose of these medications to doctors, which was created using artificial intelligence (AI) techniques applied to large medical databases. The method used is called reinforcement learning, and we call the technology the "AI Clinician". In the AI Clinician XP1, the investigators tested the safety of the AI Clinician when running in "shadow mode", i.e. in pseudonymised batches of patient data presented to off-duty ICU clinicians. This enabled the investigators to 1) develop methods and software to connect to real-time electronic health records (EHR); 2) check the safety of the algorithm when used in a contemporary UK ICU patient cohort. In XP2, the AI Clinician will be running in real-time on dedicated computers at the bedside of actual patients in 4 ICUs across 2 NHS Trusts (Three ICUs at ICHT and one ICU at UCLH).

NCT ID: NCT05742477 Not yet recruiting - Neonatal Sepsis Clinical Trials

Treatment Outcome With Antibiotic Use and Its Resistance Pattern Among Patient With Neonatal Sepsis

Start date: March 31, 2023
Phase:
Study type: Observational

Determine Treatment outcome with antibiotic use and its resistance pattern among neonatal sepsis patients

NCT ID: NCT05741801 Recruiting - Sepsis Clinical Trials

Digital Alerts for Sepsis: a Qualitative Study

DiAlSQual
Start date: November 4, 2022
Phase:
Study type: Observational

Sepsis is a serious disease, most often caused by a bacterial infection, and can be treated with antibiotics. Identifying patients with sepsis as early as possible means treatment with antibiotics can be started earlier. To identify patients who may have sepsis, measurements such as high or low temperature and fast breathing rate are used to create a score showing the possibility of sepsis. Electronic Health Records (EHRs) in hospitals contain the information needed to create a score and can alert a doctor or nurse that a patient may have sepsis. Research has shown that more patients get antibiotics earlier because of hospitals using this type of digital alert. Different hospitals have used different methods to create a score and use different types of digital alerts. This research wants to find out what hospital doctors and nurses think about digital alerts for sepsis and how they use them. The investigators also want to find out what patients who have had sepsis think about hospitals using these digital alerts. Understanding how these digital alerts are used and how they affect patient care can help see how they could be used better so patients can benefit.

NCT ID: NCT05740150 Recruiting - Clinical trials for Central Line-associated Bloodstream Infection (CLABSI)

Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.

CATERPILLAR
Start date: October 27, 2020
Phase: N/A
Study type: Interventional

The goal of this assessor blinded randomized controlled trial is to compare a lock solution containing taurolidine, citrate and heparin to a heparin only lock solution for the prevention of central line associated bloodstream infections in paediatric oncology patients with a central venous access device.

NCT ID: NCT05739604 Completed - Sepsis Clinical Trials

Serum Free Amino Acid Concentrations in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)

Start date: June 19, 2020
Phase:
Study type: Observational

Sepsis is a life-threatening condition associated with high morbidity and mortality. The breakdown of proteins mainly from skeletal muscles leads to the release of free amino acids (FAAs). The serum FAA pool has been repeatedly assessed and found to be significantly altered in patients with sepsis/septic shock. Sepsis is well known to be the most common factor contributing to the development of acute kidney injury in critically ill patients. The investigators want to establish the baseline profile of FAAs and their derivatives in patients with sepsis/septic shock undergoing continuous renal replacement therapy due to sepsis-associated acute kidney injury. Secondly, the investigators want to compare the FAA profiles of the survivors and nonsurvivors.