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Sepsis clinical trials

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NCT ID: NCT06238180 Recruiting - Sepsis Clinical Trials

Personalised Real-time Interoperable Sepsis Monitoring (PRISM)

PRISM
Start date: November 29, 2023
Phase:
Study type: Observational

The goal of this prospective observational study is to develop and utilize an Artificial Intelligence (AI) model for the prediction of postoperative sepsis in patients undergoing abdominal surgery. The main questions it aims to answer are: 1. Can a remote AI-driven monitoring system accurately predict sepsis risk in postoperative patients? 2. How effectively can this system integrate and analyze multimodal data for early sepsis detection in the surgical ward? Participants are equipped with non-invasive PPG-based wearable devices to continuously monitor vital signs and collect high-quality clinical data. This data, along with demographic and laboratory information from the Electronic Health Record (EHR) of the hospital, are used for AI model development and validation.

NCT ID: NCT06227104 Recruiting - Clinical trials for Secondary Outcome : 30-day Mortality, Renal Recovery, Length of Hospital Stay

Efficacy of Convection-based HDF Compare With Diffusion-based HD in Sepsis-associated AKI

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Acute kidney injury (AKI) is a common complication among patient admitted in the hospital worldwide, with estimates of prevalence ranging from less than 1% to 66%.1, 2 In critically ill patients approximately 49% were acute kidney injury network (AKIN) stage 3 which required intensive care unit (ICU) admission, kidney replacement therapy (KRT), and is associated with higher mortality rate.3 Sepsis-associated acute kidney injury (S-AKI) is a frequent complication in critically ill patient and is associated with high morbidity and mortality. S-AKI is defined as AKI in presence of sepsis without other significant contributing factors or simultaneous presence of both Sepsis-3 definition and Kidney Disease Improving Global Outcomes (KDIGO) criteria for AKI. 4, 5 Multicentre studies show that 30-60% of critically ill patient having AKI, and approximately 10-15% require KRT.6 Both Online-hemodiafiltration (OL-HDF) which is convection-based hemodiafiltration and conventional intermittent hemodialysis (IHD) which is diffusion-based hemodialysis are modalities of KRT that can be used to treat AKI in sepsis.7 Conventional intermittent hemodialysis (IHD) involves the removal of waste products and excess fluids from the blood by using a semipermeable membrane that acts as an artificial kidney. However, IHD has limitations in removing certain larger solutes, such as cytokines, which are involved in the inflammatory response associated with sepsis. In contrast, OL-HDF is a more advanced form of hemodialysis (HD) that combines convective clearance with diffusive clearance, resulting in more efficient removal of larger solutes.8 Several studies have suggested that OL-HDF may have advantages over conventional HD in the management of sepsis-associated AKI.9 Some studies found that OL-HDF was associated with improved patient survival and lower incidence of dialysis dependence compared to conventional IHD. Additionally, some studies have suggested that OL-HDF may have anti-inflammatory effects, which could be beneficial in sepsis.9-11 Some observational studies have shown that OL-HDF provide benefit over IHD including, a reduction in the length of ICU stay and a decrease in inflammatory surrogate markers. However, the effect of OL-HDF in improving survival has not yet been established. 1, 7, 9 Some studies have shown that sustained low-efficiency dialysis (SLED) may has advantage in hospital survival in over the continuous veno-venous hemofiltration (CVVH) modality.12 While there are several extracorporeal treatment modalities for AKI in critically ill patients but no randomized study has yet demonstrated a survival benefit over another. A prospective and comparative study between IHD and OL-HDF groups showed no significant difference in mortality between the groups. However, a significant benefit in terms of a reduced length of ICU stays and vasopressor free day was found in the OL-HDF group.13 The past studies show that CRP and IL-6 levels increase in patients treated with IHD and remain stable in patients treated with OL-HDF, with a statistically significant difference. 14 In AKI patient, our aim is to remove small molecules such as uremic toxin or metabolic abnormalities. In chronic kidney disease, the benefit of high flux dialyser or OL-HDF to remove middle to large molecule such as ß2-microglobulin and others chronic inflammation molecules and cytokines through a combination of diffusion-based and convection-based techniques are well-known. These cytokines including C-reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), procalcitonin (PCT), which are commonly elevated in AKI patient, have been shown to be significantly reduced by using hemodiafiltration techniques. 9, 15 However, the benefits of removing middle molecule and inflammatory makers in the acute setting such as AKI in critically ill patient remain controversial.11, 16, 17 Therefore, this study aims to verify the benefit of convection-based treatment in reducing inflammatory molecule such as CRP over diffusion-based treatment in both critically-ill and standard AKI patients. However, it is important to note that OL-HDF requires specialized equipment and may be more complex to administer compared to conventional IHD. Additionally, it is generally more expensive. Therefore, the choice of KRT modality in sepsis-associated AKI should be based on careful consideration of the individual patient's clinical status and available resources.7 It is important to note that every patient's condition is unique and requires individualized treatment, so the specific choice of KRT modality should be made in consultation with a healthcare professional.

NCT ID: NCT06226441 Recruiting - Sepsis Clinical Trials

Aminoglycoside Administration in Septic Patients

AMASEP
Start date: June 2, 2023
Phase: N/A
Study type: Interventional

Sepsis is one of the main causes of mortality and morbidity in an ICU setting, while the responsible microorganisms most frequently isolated are multidrug-resistant gram-negative bacteria. Aminoglycoseides (AG) seem to be particularly effective in dealing with these microbes, however their potential toxicity, especially nephrotoxicity, often makes them an unsuitable treatment option. This becomes particularly evident in patients with already impaired renal function, a common occurrence in septic patients requiring ICU treatment. AG are bacteriocidal antibiotics the efficiency of which depends on the maximum concentration in patients' serum (Cpeak). Pathophysiological changes in critically ill patients, result in significant distribution of the drug extravascullary resulting in a decreased concentration of the biologically active component. On the other hand, impaired renal clearance results in high serum drug levels (C trough) making the desired once-daily administration not always achieved. The purpose of this study is to test the hypothesis of successful clearance of AG after achieving satisfactory serum levels and therefore their maximum effect minimizing potential toxicity, by using continuous veno-venous haemodiafiltration in patients with sepsis or septic shock and impaired renal function. This way, the aforementioned antibiotics could become a more frequent and potentially earlier choice for physicians in the treatment of sepsis and septic shock patients from multidrug-resistant microbes.

NCT ID: NCT06219135 Recruiting - Sepsis Clinical Trials

Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis

IDBIORIV
Start date: March 21, 2024
Phase:
Study type: Observational

Sepsis is a disruption of homeostasis in the human body in response to bloodstream infection and is associated with a high risk of mortality. Worldwide, sepsis is affecting approximately 30 million people and resulting in six million deaths. Blood culture is a specific blood sample used to identifying microbial agent (bacterium or yeast) and determine the sensitivity of these microorganisms to antibiotics and antifungals. Any delay in identifying the microorganism and/or determining the AST (antibiotic susceptibility testing) has a direct impact on the administration of appropriate antibiotic treatment and, consequently, on mortality of the patient. The faster the diagnosis, the faster the antibiotic treatment will be adapted, the higher the survival rate/probability of patients, and the lower the ecological impact. In routine, clinical microbiology laboratories currently use 2 automatized techniques: MALDI-TOF MS® for microorganisms identification and VITEK2® method for AST determination. Based on a proteomic approach, the IDBIORIV method is a rapid method (90 minutes) in comparison of current methods (24/48 hours) able to identifying a large panel of 113 pathogens and determine the antibiotic resistance profile of 49 species for 4 classes of antibiotics (Beta-lactams, Aminosides, Glycopeptides, Colistin). The main objective of this study is to evaluate the performance of the IDBIORIV method in pathogen identification and antibiotic susceptibility testing in comparison with current methods of analysis of positive blood cultures used at the microbiology laboratory of the Hospices Civils de Lyon, in a real clinical situation, over a 2-year period.

NCT ID: NCT06216080 Recruiting - Critically Ill Clinical Trials

Dynamic Full-Field Optical Coherence Tomography for Structural and Microbiological Characterization of Central Venous Catheter-deposited Biofilm in Critically Ill Patients

OCT-BIO-CVC
Start date: May 1, 2023
Phase:
Study type: Observational

29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, with a significant proportion related to central venous catheters, and an influence on both morbility and mortality. It is now accepted that microbiological biofilm plays a key role on both bacterial and fungal development on inner surface of vascular devices but there is yet a lack of clinical relevant data documenting a causal relation between biofilm formation and bacteremias. We assume that a more precise characterization of central venous catheter-deposited biofilm could help us better understand invasive medical device-related healthcare infections in critically ill patients.

NCT ID: NCT06210425 Recruiting - Sepsis Clinical Trials

Is Re-examination of Urine Culture Necessary for Patients With Preoperative Positive Results in Predicting Infectious Complications Related to Mini-Percutaneous Nephrolithotomy?

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

Objective To explore the predictive value of urine culture re-examination in identifying infectious complications associated with mini-PCNL in patients with preoperative positive urine culture who were treated with sensitive antibiotics. Methods Prospective and consecutive clinical data were collected from patients whose preoperative urine culture was positive and who underwent PCNL at the Department of Urology, the First Affiliated Hospital of Guangzhou Medical University. If patients'preoperative urine cultures were positive, they would be treated with appropriate antibiotics in accordance with the culture-antibiogram test results, and urine cultures were repeated on day 3 and day 7. Patients would undergo mini-PCNL after the treatment of sensitive antibiotics for 7 days, and the correlation between the results of urine culture on day 3 and day 7 and infectious complications related to mini-PCNL after surgery was analyzed.

NCT ID: NCT06197269 Recruiting - Clinical trials for Early-Onset Neonatal Sepsis

Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis

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

Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset sepsis.

NCT ID: NCT06193980 Recruiting - Sepsis Clinical Trials

Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness

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

This study aims to investigate how sepsis and shock can impair microcirculation in intensive care unit (ICU) patients, which can lead to long-lasting muscle weakness/dysfunction or ICU-Acquired Weakness (ICU-AW) and exercise limitations.

NCT ID: NCT06187168 Recruiting - Sepsis Clinical Trials

Risk Factors of Post-ERCP Sepsis

Start date: December 23, 2023
Phase:
Study type: Observational

For the treatment of numerous biliary and pancreatic problems, the procedure known as endoscopic retrograde cholangiopancreatography (ERCP) is regarded as a crucial therapeutic intervention. However, ERCP is known to be connected to a variety of issues, including post-ERCP sepsis. This study's goal is to investigate the relationship between unexplained hypotension during or just after surgery and the emergence of sepsis after ERCP.

NCT ID: NCT06181422 Recruiting - Sepsis Clinical Trials

Metformin and Lactoferrin in Sepsis in Icu

Start date: April 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Sepsis is a life-threatening organ dysfunction triggered by an unregulated response of a host to infection. Sepsis is a reason for substantial mortality and morbidity among intensive care unit (ICU) patients. 1 Therefore, the aim of our study is to compare the safety and efficacy of metformin and lactoferrin in ICU patients with sepsis.