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Sepsis clinical trials

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NCT ID: NCT05978154 Recruiting - Sepsis Clinical Trials

Thigh Muscle Mass and Muscle Wasting in Patients in the Emergency Department

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

The goal of this observational study is to evaluate whether thigh muscle mass and muscle wasting are associated with mortality in patients who visit the emergency department. The main questions it aims to answer are: - Is thigh muscle mass associated with mortality in patient who visit the emergency department? - Does muscle wasting exist during staying in the emergency department? - Is muscle wasting associated with mortality in patient who visit the emergency department? Participants will be evaluated for serial thigh muscle mass using point-of-care ultrasound at the emergency department.

NCT ID: NCT05977153 Recruiting - Clinical trials for Mechanical Ventilation Complication

CT for Personalized Mechanical Ventilation

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to compare two different ways of helping patients with a condition called sepsis who need help breathing using a machine called a ventilator. The investigators want to study which way of setting the ventilator is better for the lungs. Here are the main questions the investigators want to answer: 1. How does the amount of air in the lungs and the way it moves differ between the two ways? 2. How does the way air spreads out in different parts of the lungs differ between the two ways? In this study, the investigators will take special pictures of the lungs using a machine called a CT scan. The pictures will show us how much the lungs stretch and how much air is in different parts of the lungs. The investigators will compare two different ways of using the ventilator: one personalized for each patient based on their breathing, and another way that is commonly used. By comparing these two ways, the investigators hope to learn which one is better for helping patients with sepsis who need the ventilator. This information can help doctors make better decisions about how to care for these patients and improve their breathing.

NCT ID: NCT05975671 Recruiting - Sepsis Clinical Trials

Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis

REVAMP
Start date: August 21, 2023
Phase: N/A
Study type: Interventional

The goal of this quasi-experimental interventional study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care Pediatric Intensive Care Units (PICU). There are two groups of subjects in this study: PICU clinicians/sepsis stakeholders and patients admitted to one of the participating PICUs during the study period. The intervention will at a minimum include: - Implementation of a clinical guideline indicating when vancomycin should and should not be used - Unit-level feedback on overall vancomycin use within and across centers - Clinician education.

NCT ID: NCT05971979 Recruiting - Sepsis Clinical Trials

Therapeutic Drug Monitoring - Targeting IMproved Effectiveness

TDM-TIME
Start date: December 14, 2023
Phase:
Study type: Observational

Severe infections can be caused by various organisms, such as bacteria or viruses, and lead to otherwise healthy people getting very unwell, sometimes needing treatment in hospital or even intensive care. For the treatment of bacterial infections to be successful, the correct antibiotics need to be given promptly. Early in the course of illness, clinicians often do not know exactly which bacteria are causing the infection. Furthermore, patients differ in terms of how their bodies process the antibiotics they are given; this means that some may get too much and others too little. This can in turn lead to some patients not being fully cured, and others coming to harm due to side effects of higher doses of these drugs. For certain types of antibiotics, clinicians are able to measure their levels in the bloodstream, which can help guide dosing. This is called therapeutic drug monitoring, and is commonly used in clinical practice. One of the problems with therapeutic drug monitoring is that it is often not available outside of regular working hours, is costly, and most importantly, provides clinicians with useful information only after a few days of treatment have already been completed. This may be too late to treat these severely ill patients with life-threatening infections, where early and appropriate treatments matter. The aim of our study, called TDM-TIME, is to look at how long it takes for blood samples to get from the patient to the laboratory to be measured, with the results then communicated back to clinicians. We are further looking to investigate whether steps can be taken to improve these timings, which would lead to shorter times until treatments can be improved. As our study is observational, we will not change anything about the treatment of our patients, but will only be measuring levels of antibiotics in their blood.

NCT ID: NCT05969275 Recruiting - Sepsis Clinical Trials

Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

UC-CISSII
Start date: February 14, 2024
Phase: Phase 2
Study type: Interventional

Septic shock is associated with substantial burden in terms of both mortality and morbidity for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem (stromal) cells (MSCs) modulate inflammation, enhance pathogen clearance and tissue repair and reduce death. Our team has completed a Phase I dose escalation and safety clinical trial that evaluated MSCs in patients with septic shock. The Cellular Immunotherapy for Septic Shock Phase I (CISS) trial established that MSCs appear safe and that a randomized controlled trial (RCT) is feasible. Based on these data, the investigators have planned a phase II RCT (UC-CISS II) at several Canadian academic centres which will evaluate intermediate measures of clinical efficacy (primary outcome), as well as biomarkers, safety, clinical outcome measures, and a health economic analysis (secondary outcomes).

NCT ID: NCT05959018 Recruiting - Clinical trials for CLABSI - Central Line Associated Bloodstream Infection

Efficacy & Cost Effectiveness of Antimicrobial-impregnated CVCs in CLABSI Prevention in a Malaysia Adult ICU

Start date: January 19, 2024
Phase: N/A
Study type: Interventional

Central venous catheters (CVCs) are indispensable in modern critical care. However, CVC usage is associated with complications, including central line-associated bloodstream infections (CLABSIs), which in turn, is translated to higher healthcare costs and mortality. The use of antimicrobial-impregnated CVCs is one of the strategies to reduce CLABSI. Nevertheless, its' efficacy and beneficial effects, particularly in terms of patients' outcome had not been homogeneously demonstrated across literature. Moreover, antimicrobial-impregnated CVCs are more expensive compared to conventional non-impregnated ones, and hence its cost-effectiveness remains doubtful. To date, no local studies have been conducted to evaluate the efficacy and economic impact of antimicrobial-impregnated CVCs and on patients' outcome. The goal of this clinical trial is to determine the efficacy and cost-effectiveness of antimicrobial-impregnated CVCs in preventing (CLABSI) among critically ill patients in a Malaysia University Hospital Adult Intensive Care Unit. The main questions it aims to answer are: 1. Is there any difference in CLABSI rates between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU? 2. Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in Malaysia adult ICU affect patient length of stay when compared to non- impregnated CVCs? 3. Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in the adult ICU setting affect healthcare costs when compared to non-impregnated CVCs? 4. How antimicrobial resistance features of the bacteria causing CLABSI may differ in patients using antimicrobial-impregnated CVCs compared to non-impregnated CVCs? Patients who require a CVC for critical care in ICU will be recruited and randomly assigned to one of the two different groups to receive either a conventional non-impregnated CVC or an antimicrobial-impregnated CVC, which will be inserted and handled by medical practitioners. Participants will then be monitored for symptoms and signs of CLABSI, alongside length of ICU stay & healthcare costs. Researchers will compare CLABSI rates and other relevant parameters among the 2 groups to see if antimicrobial-impregnated CVCs are useful and cost-effective in CLABSI prevention.

NCT ID: NCT05955612 Recruiting - Sepsis Clinical Trials

Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults

PROCALBAN
Start date: July 26, 2023
Phase: Phase 3
Study type: Interventional

Trial design: Randomised controlled, two-arm, parallel, clinical trial to assess the efficacy and safety of sequential daily procalcitonin assessments to guide de-escalation of empirical antibiotic therapy in adult patients with sepsis. Trial settings Trial site is Chattogram Medical College Hospital (CMCH), Bangladesh. CMCH is tertiary care hospital with undergraduate and postgraduate teaching facilities. This tertiary hospital receives referrals from urban and rural areas of southern Bangladesh and has basic facilities for intensive care and haemodialysis. Trial Participants: Male or female hospitalised patients, 16-65 years of age, with confirmed or suspected sepsis Patients (Total 532) will be 1:1 randomised to either: - Intervention arm: daily measurement of serum procalcitonin concentrations to guide de-escalation of antibiotics (Intervention arm: 266), or - Control arm: standard of practice to guide de-escalation of antibiotics without procalcitonin assessments (Control arm: 266). Patients will be followed-up until ICU discharge and/or hospital discharge with an additional follow-up at 28 days after discharge. Funder: Wellcome Trust of Great Britain Grant reference number from Wellcome Trust: 220211/A/20/Z

NCT ID: NCT05950984 Recruiting - Sepsis Clinical Trials

Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)

MD-PK
Start date: October 30, 2023
Phase:
Study type: Observational

Getting the right dose of antibiotic promptly is an important part of treating infections. Unfortunately, when an infection is severe (sepsis) the body changes how it processes antibiotics. Consequently, some people with severe infection retain antibiotics for too long (risking adverse effects), whilst others excrete antibiotics too quickly (risking under-treatment). Mathematical models can help researchers understand drug handling variability (known as pharmacokinetics) between people. These models require very accurate information about drug administration and drug blood concentration timings. Researchers usually rely on someone recording these timings, but recording errors can make models inaccurate. We would like to understand if using data from routinely used electronic drug infusion devices (recording the exact time of administration) can improve the accuracy of pharmacokinetic models. We intend to investigate this with an antibiotic (vancomycin) that clinicians already routinely monitor blood concentrations for. Adults and children treated at St George's Hospital intensive care units will be invited to participate in the study which will last for 28-days within a 14-month period. Participants will donate a small amount of extra blood and provide researchers access to their clinical data. Blood will be taken at special times during vancomycin treatment from lines placed as part of standard treatment, minimising any pain or distress. There will be no other changes to patient's treatment. In the future, data from this study might help change the way we dose antibiotics. The National Institute for Health and Care Research and Pharmacy Research UK are supporting the study with funding.

NCT ID: NCT05942157 Recruiting - Sepsis Clinical Trials

Therapeutic Drug Monitoring in Patients With Difficult-to-Treat Gram-Negative Bacterial Infections

TDM-RCT
Start date: March 29, 2023
Phase: N/A
Study type: Interventional

A prospective, open-label, randomized controlled trial will be conducted to evaluate a novel TDM-guided therapy in management of DT-GNB infections. We hypothesize that TDM-guided antibiotic therapy will reduce 14-day all-cause mortality by 6% (absolute risk reduction) in septic patients with DT-GNB infections, when compared to standard therapy. TDM for 11 antibiotics will be performed for all trial patients although test information will be withheld for the standard therapy arm. The primary aim is to compare the 14-day all-cause mortality rates of novel TDM-guided antibiotic dosing versus standard therapy.

NCT ID: NCT05941624 Recruiting - Sepsis Clinical Trials

Comparison Between HA330 Hemoperfusion Filter Hemodialysis and Conventional High-Flux Hemodialysis Filter

Start date: June 16, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effectiveness between conventional hemodialysis and hemodialysis using hemoperfusion adsorbents in renal dysfunction caused by sepsis