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NCT06712641
Norwegian guidelines for empirical antibiotic therapy in suspected community acquired sepsis recommend the combination of narrow spectrum betalactam and aminoglycoside as the first choice, but broad spectrum betalactams are considered equally appropriate, effective, and safe. However, fear of renal complications due to gentamicin and concern for lacking evidence for efficiency commonly leads to the use of broad spectrum betalactam therapy, a larger driver of antibiotic resistance. In patients with suspected community acquired sepsis, the investigators hypothesize that empirical combination therapy with narrow spectrum betalactams and aminoglycosides is safe and non-inferior to empirical therapy with broad spectrum betalactams. More specifically, the investigators hypothesize that the proportion of patients with acute kidney injury or death will be similar between these two treatment groups. Furthermore, the investigators hypothesize that the aminoglycoside-based regimen has lesser impact on the gut microbiome. Antimicrobial resistance is one of the most urgent health threats of our time, and Norwegian hospitals were required but failed to reduce the use of broad-spectrum antibiotics with 30% by the end of 2020. In this context, novel initiatives aiming at reducing use of antibiotics are direly needed.
NCT05127109
This is a research study to determine if a particular method of providing nutrition improves the clinical outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method we are testing is a structured nutrition delivery plan that involves tube feeding, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. This study will also use two devices to measure fat and muscle mass to examine changes during hospitalization. Subjects will be followed throughout hospitalization where nutrition status and fat and muscle mass will be closely monitored. Study activities will begin within 72 hours of a patient's abdominal surgery. TPN (total parenteral nutrition, a method of feeding that bypasses the usual process of eating and digestion) will be started, a non-invasive method of assessing calorie needs (indirect calorimetry (IC)) will be started, a urine sample will be collected to help assist in protein needs, and fat/muscle mass will be measured using bioelectrical impedance analysis (BIA), and an ultrasound. This is a minimal risk study and all products/devices used are non-invasive and FDA-approved. Indirect calorimetry and urine sample collection will be conducted every 3 days during the stay in the Intensive Care Unit - ICU, then every 5 days until hospital discharge. BIA and muscle ultrasound will be conducted every 7 days during ICU stay, then every 14 days until hospital discharge.
NCT07543497
The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore.
NCT07533994
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, with high morbidity and mortality worldwide. Reliable biomarkers are needed for early risk stratification and outcome prediction. This prospective, single-center, observational study aims to evaluate the prognostic value of Acod1 gene expression in peripheral blood mononuclear cells (PBMCs) from septic patients. The primary objective is to assess the sensitivity and specificity of ACOD1 expression measured by RT-qPCR within 24-48 hours of ICU admission for predicting sepsis mortality. Secondary objectives include correlating ACOD1 expression with the SOFA score, and comparing its predictive performance against established clinical markers and scores such as APACHE II, SOFA, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), arterial lactate, and IL-1β expression. The study will also report in-hospital mortality. Findings may support ACOD1 as a novel molecular biomarker for early prognostic assessment in sepsis.
NCT07367113
This prospective, randomized, controlled trial aimed to evaluate whether fluid resuscitation guided by the Peripheral Perfusion Index (PPI) could reduce the incidence of Acute Skin Failure (ASF) in elderly critically ill patients. A total of 216 patients aged ≥65 years with sepsis or other types of shock requiring early aggressive fluid resuscitation were enrolled and randomly assigned in a 1:1 ratio to either the PPI-guided resuscitation group or the conventional resuscitation group. The intervention group targeted maintaining PPI ≥1.4 in addition to conventional hemodynamic goals, while the control group followed standard resuscitation protocols. The primary outcome was the incidence of ASF within 7 days of ICU admission, diagnosed according to NPUAP/EPUAP (2014) criteria. Secondary outcomes included time to ASF occurrence, lactate clearance, cumulative fluid balance, organ function, and long-term prognosis.
NCT07516236
This prospective observational diagnostic accuracy study investigates the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock, compared to measurements obtained using echocardiography (VTI) and cardiometry. We will correlate the changes in measuring cardiac output by both echocardiography and cardiometry with the changes in dynamic central venous oxygen saturation both at baseline and after fluid challenge to investigate the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock.
NCT07502794
This study is a prospective, observational cohort clinical registry designed to describe clinical and epidemiological characteristics and outcomes of adult patients hospitalized with sepsis. Participants will be followed during hospitalization and after hospital discharge to evaluate short- and long-term outcomes.
NCT07356583
The Enterovirus genus, belonging to the Picornaviridae family, consists of positively polarized single-stranded RNA viruses classified into the species Enterovirus (EV, comprising Coxsackievirus, Echovirus and Poliovirus) A-J and Rhinovirus (RV) A-C, of which more than 200 different genotypes have been described. Enteroviruses have a global spread and are a common cause of febrile, gastroenteric and exanthematous diseases, usually self-limiting, which are widespread in infants and pediatric populations. However, they can occasionally cause serious diseases, including meningoencephalitis, myelitis, paralysis, myocarditis, sepsis, severe respiratory syndromes, and acute hepatitis. They can be transmitted by respiratory route, with most cases in temperate regions occurring during summer and early autumn. Enteroviruses are characterized by a rapid evolution determined by the high mutation rate (due to the presence of an RNA-dependent RNA-polymerase that lacks proofreading activity) and the high probability of undergoing recombination events. The latter, in particular inter-typical recombination, plays a crucial role in the evolutionary process of Enteroviruses and has been recognized as a major cause of the emergence of strains with higher pathogenicity and/or epidemic potential, although the associated genetic determinants are not known to date. Between July 2022 and April 2023, nine cases of neonatal Echovirus 11 (E-11) infection with severe liver failure and neurological and myocardial involvement were reported in France; seven of these cases resulted in fatal outcomes. Following these reports, the World Health Organization (WHO) issued an alert that quickly led to the identification of further cases in Italy, Spain, Croatia and the United Kingdom. As EV infections are not subject to systematic surveillance, there is a lack of data on the actual burden of disease associated with these infections. Thus, EV infections are underestimated and, even more so, data on their typing are scarce - if not absent -, which involve second-level analyses that are generally not carried out routinely in clinical microbiological diagnostic laboratories, are rarely available and are not systematically collected, not even at European level. A condition that therefore makes it impossible to estimate either the impact of EV infections in general, and of E-11 in particular, or the risk factors related to the most serious cases and the most significant transmission routes. Moreover, the characteristics of the immunological and inflammatory response to infection remain to be defined. These elements would allow, if available, the formulation of a specific case definition to ensure rapid laboratory confirmation and recognition of the disease.To strengthen knowledge of the spread and impact of enterovirus infections in newborns, with a focus on E-11, by carrying out the following activities, within the scope of the project's proposed objectives: design and pilot implementation (proof of concept) of epidemiological and genomic surveillance systems with potential national application; molecular characterization and evaluation of viral pathogenic features; search for possible immunological markers and host risk factors associated with severe EV disease, including E-11. Specific objectives 1. To implement and validate a protocol for screening activities in neonatal units and neonatal intensive care units aimed at checking for the presence of infections caused by EV and identifying severe forms of infection, with particular attention to E-11. 2. Characterize EV strains, identified within the activities carried out by specific objectives 1, using next-generation sequencing (NGS) approaches to obtain the whole genome sequence and identify possible recombinant forms. Carry out phylogenetic analysis of the obtained sequences compared with those deposited in the main international databases, to define genomes that can be traced back to variant strains or with specific mutations in the genome.
NCT06517810
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT. The purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE
NCT07172451
The goal of this randomized clinical trial is to evaluate whether balanced gelatin solution is more effective and safe than balanced crystalloid solution for perioperative fluid management in adults with sepsis undergoing emergency abdominal surgery. Sepsis often causes severe fluid loss from the bloodstream into tissues, leading to low blood pressure, impaired organ function, and the need for urgent fluid resuscitation. Balanced gelatin, a colloid solution, may help maintain intravascular volume more effectively than crystalloid alone. In this study, participants are randomly assigned in a 1:1 ratio to receive either balanced gelatin or Ringer's acetate during surgery and in the first 24 hours afterward. All patients receive standardized anesthesia care, goal-directed fluid therapy, and protocolized use of vasoactive drugs. The main questions the study aims to answer are: * Does balanced gelatin reduce positive fluid balance within 24 hours after surgery? * Does it improve hemodynamic stability during the early postoperative period? * What effects does balanced gelatin have on kidney function, microcirculation, postoperative recovery, and other clinical outcomes? Participants will be followed throughout hospitalization and contacted again on postoperative day 28 and day 90 to assess survival, complications, and health-related quality of life. The trial is double-blind, meaning that patients, clinicians, and outcome assessors do not know which fluid is being used. An independent Data and Safety Monitoring Board will oversee patient safety during the study. The findings of this trial are expected to provide important evidence to guide perioperative fluid resuscitation strategies for septic patients undergoing emergency surgery.
NCT07480434
Lactoferrin (LF) is a multifunctional glycoprotein and is naturally present in various body secretions, including human milk, tears, saliva, airway mucus, and the secondary granules of neutrophils 1-2. It plays a crucial role in innate infant immunity by exerting immunomodulatory, antimicrobial and anti-inflammatory effects. The biochemical and molecular properties of LF, such as ferric iron transport, enzymatic activity, and nuclear binding for transcriptional regulation, essentially make it a versatile defense molecule in host-pathogen interactions. Sepsis remains leading cause of morbidity and mortality in vulnerable populations , placing significant burdens on healthcare systems and families. Despite advancements in neonatal care, strategies to effectively reduce these risks remain limited, necessitating a focus on prophylactic interventions that are safe and evidence-based. This study is designed to fill the gaps of possible preventive strategy for sepsis among premature babies and to evaluate the effectiveness of enteral lactoferrin supplementation in decreasing the clinical sepsis among preterm neonates.
NCT07472452
In recent studies, it has been reported that the renal resistance index is effective in detecting sepsis-related acute renal failure (SA-AKI) in the early period. Similarly, urinary biomarkers \[TIMP-2\]\*\[IGFBP-7\], released in response to tubular epithelial cell stress, have been reported to indicate the presence of acute renal injury (AKI) early on, before functional loss occurs (increased creatinine). This observational study aims to evaluate the renal resistance index and urinary biomarker variation in patients diagnosed with sepsis and to investigate their usefulness in the early detection of renal dysfunction that may develop after sepsis.
NCT04955210
1\. To research the current situation of severe infection in children in China, and to investigate the incidence, prognosis and disease burden of severe infection in children in different regions of China. 2. Establish the risk prediction model and diagnosi model of severe infection in children, and verify the accuracy of the model in multi-center; 3. To study the effectiveness and safety of different treatments in real diagnosis and treatment, and to evaluate the efficacy of subgroups under different ages and high risk factors.
NCT04794595
The effect of continuous blood purification (CBP) in children is unclear. Also, the timing of early application is still being explored. In this study, we need to explore the efficacy and the timing of application of CBP in children with sepsis or septic shock.
NCT04850456
The inflammatory storm in critically ill patients releases cytokines, causing systemic immune damage, which may be an important cause of multiple organ failure and even death. Inflammatory storms exacerbate the deterioration of the disease in those children. Gamma globulin may be an effective option to control inflammatory storms. However, this preliminary result needs to be verified from reliable and representative RCTs. In our study, we conducted a retrospective study on the use of gamma globulin and an unused control group. At present, the indications of IVIG are mainly focused on the neuromuscular system and the blood system. We hope to establish a more appropriate and operable evaluation table for the suitability of gamma globulin for clinical use.
NCT05267821
The TRIPS study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyperinflammation in children with sepsis-induced multiple organ dysfunction syndrome (MODS).
NCT07179276
Sepsis is a dysregulated host response to infection that leads to life-threatening organ dysfunction and represents a major healthcare problem. Septic shock is the most severe form, characterized by increased capillary permeability and vasodilation, resulting in hypotension and tissue hypoxia. Early identification and treatment of tissue hypoperfusion are pivotal components of initial resuscitation to limit progression to multiple organ dysfunction and death. The 2021 Surviving Sepsis Guidelines recommend guiding initial resuscitation by targeting decreases in serum lactate levels in patients with elevated lactate. However, although elevated lactate levels may reflect tissue hypoxia, serum lactate is not a direct marker of tissue perfusion. Hyperlactatemia may be attributable to mechanisms other than tissue hypoperfusion, such as accelerated aerobic glycolysis driven by excessive β-adrenergic stimulation or impaired clearance (e.g., in liver failure). The venous-to-arterial carbon dioxide partial pressure difference (CO₂ gap), which is inversely related to cardiac output, has been shown to reflect the adequacy of venous blood flow to remove CO₂ from tissues. The CO₂ gap is closely linked to microcirculatory blood flow during the early resuscitation phase of septic shock and may effectively identify persistent tissue hypoperfusion in shock states. A persistently high CO₂ gap during early resuscitation has been associated with significantly higher 28-day mortality and increased Sequential Organ Failure Assessment (SOFA) scores. Moreover, the CO₂ gap has been shown to respond to changes in cardiac output during inotrope infusion in patients with low blood flow, suggesting that its assessment could be useful for therapeutic adjustments. Therefore, there are compelling arguments to evaluate the usefulness of the CO₂ gap in guiding early resuscitation in patients with septic shock. The investigators postulated that CO₂ gap-guided early resuscitation may be more effective in improving outcomes than lactate-guided resuscitation.
NCT06709573
The goal of the CASPER-Pilot study is to develop clinical decision support (CDS) technology within Epic to randomize patients with septic shock to early versus standard of care vasopressin initiation. The primary aim of this study will be to test the hypothesis that CDS technology can be utilized to create two distinct cohorts of patients reflecting different times of vasopressin initiation based on norepinephrine dose requirements. Secondarily, this study will evaluate the proportion of patients whose norepinephrine dose at the time of vasopressin initiation is within the specified range for the intervention arm they were randomized to. Other outcomes of evaluation will include adherence to the developed CDS technology and comparison of clinical outcomes between the two treatment arms.
NCT07460349
A previous pharmacy residency project was done 20 years ago looking at the best dosing for the antibiotic gentamicin for babies up to 7 days old. This study showed that giving the dose less often leads to better drug concentrations than giving the dose more often. Our gentamicin dosing at the Children's Hospital at London Health Sciences Centre is based on the better dosing from the study. This dosing is gentamicin 3 mg/kg every 24 hours for babies less than 35 weeks gestational age and 3.5 mg/kg every 24 hours for babies at least 35 weeks gestational age. These results were never published. Different dosing is used at different hospitals. It is important that we check that our gentamicin dosing is still reaching safe and effective drug concentrations in the current study. The study will look at the gentamicin drug concentrations of babies up to 7 days old, including premature and term babies. We will also confirm if the babies have kidney or hearing damage from gentamicin. We will compare the gentamicin drug concentrations from this study to the past data to see if the dosing is still the best. The results can help form a guideline for the Children's Hospital and surrounding hospitals.
NCT01520597
Listeriosis is a foodborne infection responsible for severe disease. Three main forms are described: septicaemia, central nervous system infections and maternal-fetal infections. Available data on the disease, are mostly retrospective and do not provide an accurate picture of the clinical / biological / genetic risk factors for the disease, nor identify any element to determine which patients are at higher risk of death, severe neurological impairment or fetal loss. The primary purpose of the study is to identify clinical, biological and genetic risk factors for systemic listeriosis and the determinants of listeriosis-associated mortality in the setting of a large prospective nation-wide study.