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Showing 1-20 of 252 trials
NCT07550400
Fluid replacement is considered the cornerstone of hemodynamic management in critically ill patients especially in patients with septic shock. However, only about 50% of critically ill hemodynamically unstable patients are responsive to fluids. Consequently, the resuscitation of critically ill patients requires an accurate assessment of the patients' intravascular volume status and their volume responsiveness. In this study, we will compare the efficacy of carotid artery flow to echo left ventricular end diastolic volume as a predictive value for fluid resuscitation in septic shock patients.
NCT07230041
The purpose of this study is to measure the change in plasma concentrations of antibiotics used during passage through the CRRT filter and hemadsorption cartridge in patients with septic shock and renal failure requiring CRRT. All patients aged \> 18 years, admitted to the ICU, diagnosed with septic shock and renal failure requiring CRRT, receiving antibiotic therapy with at least one of the following drugs: meropenem, linezolid, and daptomycin, who provided informed consent, are included in the study. Patients not admitted to the ICU, patients with renal failure not requiring CRRT, patients aged \< 18 years, or those who did not provide informed consent are excluded. The enrollment period will last 12 months and will run from September 2024 to September 2025. The expected number of patients enrolled is twenty. To proceed with the study, after starting antibiotic therapy, a 4 ml dose of blood will be drawn (Vacuette tube ref. 454092) before the cartridge, immediately after, and after the dialysis filter. This measurement will be repeated after 4, 8, and 12 hours, which represents the maximum usage time of the cartridge. After 12 hours, the cartridge becomes saturated and loses its adsorption capacity. The CRRT filter, however, remains in place for at least 72 hours before being replaced. Treatment is maintained until clinically necessary. For patients in intensive care, several blood samples are required throughout the day, both with a blood sample sent to the biochemistry laboratory every 6-8 hours to check clinical conditions, and with an arterial blood sample (blood gas) to check respiratory and metabolic status in patients on mechanical ventilation. Furthermore, in patients undergoing CRRT, electrolyte balance must be monitored every 4 hours. Therefore, the blood sample for the study inevitably coincides with one of the routine blood samples. The test tube, labeled with a unique code, will be sent to the central laboratory, which will centrifuge the blood and extract the plasma. This aliquot will then be stored at -80°C in a dedicated space and sent to the designated laboratory upon analysis. Determination of the plasma dosage of the antibiotic in use is commonly performed on patients admitted to the Intensive Care Unit, where clinically necessary. Participation in the study does not change current clinical practices.
NCT01473498
Sepsis is the most severe complication of infections. Sepsis-associated Acute kidney injury (AKI) is commonly encountered in critically ill patients and independently predicts poor outcome. Unfortunately, no drug or management strategy was able to reduce incidence of AKI. To adapt the level of mean arterial pressure according to local renal hemodynamic evaluated by renal Doppler could lead to a better renal perfusion, and then less AKI.
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.
NCT07488689
Microcirculatory dysfunction is a key driver of organ failure and mortality in septic shock, characterized by endothelial injury and impaired vasoregulation. Despite its strong prognostic value, it remains unaddressed by current therapies. SGLT-2 inhibitors (SGLT-2i) have shown promising vasculoprotective, anti-inflammatory, and glucose-lowering effects that may help restore endothelial function, reduce vascular leakage, and manage stress-induced hyperglycemia-factors central to septic shock pathophysiology. Preclinical and clinical observational studies suggest potential benefits, but clinical research in this specific context is lacking. This trial aims to evaluate the efficacy and safety of SGLT-2i in septic shock patients with clinical signs of microcirculatory failure, addressing a critical unmet medical need. Septic shock management relies on rapid infection control, hemodynamic stabilization with fluids and vasopressors, and supportive care, with corticosteroids used in select cases. However, this standardized approach faces major limitations due to patient heterogeneity, treatment-related complications (e.g., fluid overload, vasopressor side effects), and rising antimicrobial resistance. Adjunctive therapies have largely failed to improve outcomes, reflecting the complex pathophysiology of septic shock. These challenges highlight a pressing need for novel, targeted interventions and a shift toward personalized treatment strategies. The investigators hypothesize that early administration of SGLT-2 inhibitors within 14 hours of septic shock onset in patients showing signs of microcirculatory dysfunction will improve 28-day outcomes mainly by targeting endothelial and microvascular injury. Expected benefits include reduced mortality and organ dysfunction, faster recovery with lower resource use, a favorable safety profile, and potential for global implementation as a cost-effective adjunctive therapy. This study will be a multicenter, prospective, randomized, and comparative double-blind trial. All patients admitted with septic shock in the ICU will be screened for trial eligibility criteria. After verifying the eligibility criteria and obtaining patient or family consent, or after an emergency inclusion procedure, eligible patients will be randomized in a 1:1 ratio to receive either Dapagliflozin (10 mg once daily) or matching placebo in addition to standard-of-care. Patients will be followed up for 1 year or until death, whichever occurs first.
NCT04031573
Septic shock is a major health problem, with several million cases annually worldwide and a mortality approaching 45%. Tachycardia is associated with excess mortality during septic shock. This pejorative effect could be related to the increase in cardiac metabolic demand, impaired cardiac diastolic function, and/or poorer tolerance of administered exogenous catecholamines. Recent studies suggest that controlling the heart rate with the use of beta blockers has beneficial effects on the morbidity and mortality of septic shock. However, the negative effects of beta-blockers on cardiac contractility and blood pressure complicate their use during septic shock, particularly because about one-half of patients exhibit a septic-associated systolic dysfunction, which often requires the use of inotropes. Ivabradine is a selective inhibitor of If channels in the sinoatrial node. It is a pure bradycardic agent with no deleterious effect on other aspects of cardiac function (contractility, conduction and repolarization) nor on blood pressure. Ivabradine can therefore alleviate sinus tachycardia without negative inotropic effects nor hypotension. Moreover, the improvement in diastolic function (ventricular filling) with ivabradine may increase stroke volume, even in case of severe impairment of systolic function. Controlling sinus tachycardia with ivabradine during septic shock would allow reducing cardiac metabolic demand (and potentially associated ischemic events) and improving the chronotropic tolerance of exogenous catecholamines. The effectiveness of ivabradine in controlling the heart rate was demonstrated in various clinical settings such as coronary artery disease, chronic heart failure and cardiogenic shock. Encouraging preliminary data are reported in critically ill patients.
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.
NCT06693726
This pilot study will enroll 20 patients with septic shock and require emergent vasopressor support in the emergency department (ED). The primary objective of the study is to determine the feasibility of early peripheral administration of angiotensin II for treatment of septic shock in the ED
NCT04281277
This study evaluates if improvement of renal resistive index when mean arterial pressure increase (at 65 mmHg to 85 mmHg) in early phase of septic shock is predictive of better renal survival.
NCT07383103
The purpose of this study is to evaluate the efficacy and safety of the combination therapy of hydrocortisone and fludrocortisone among adult patients with septic shock.
NCT07425587
The primary objective of this study is to establish an IL-6 concentration cutoff that predicts sepsis or septic shock (according to the Third International Consensus Definitions (Sepsis-3 criteria)) in patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.
NCT05900284
Acute kidney injury (AKI) is an independent risk factor for death that affects 10-15% of hospitalized patients and more than 50% of patients admitted to the intensive care unit. Sepsis is the most frequent cause of AKI, affecting 48 million people worldwide every year, and accounting for approximately 11 million of annual global deaths. Despite these figures, there are no known therapies to prevent or reverse septic AKI; hence this study aims to establish the safety and feasibility of the implementation of metformin in the treatment of AKI in patients with sepsis. This study is the first critical step to inform the design of a future, full-scale efficacy randomized clinical trial.
NCT07418541
Septic shock is a life-threatening condition that can cause severe circulatory failure and damage to vital organs, including the kidneys. One of the most serious complications of septic shock is acute kidney injury (AKI), which is associated with increased morbidity and mortality. This study aims to evaluate the effect of early co-administration of crystalloid fluid resuscitation (30 mL/kg body weight) and norepinephrine on preventing acute kidney injury and improving hemodynamic stability in adult patients with septic shock. Patients will receive standard initial fluid resuscitation combined with early norepinephrine infusion according to a predefined clinical protocol. Changes in blood pressure, urine output, and other hemodynamic parameters will be observed before and after the intervention. The findings of this study are expected to provide evidence to support early hemodynamic optimization strategies for reducing the risk of acute kidney injury in septic shock patients.
NCT07406750
Sepsis is a serious condition where the body's immune response to infection overreacts, leading to organ damage and death. Venous congestion, a buildup of blood in the veins, can occur in sepsis and contribute to organ injury. VExUS (Venous Excess Ultrasound Score) is an ultrasound method that can detect congestion early. This study examines whether ICU nurses, after training, can perform VExUS reliably, explores their experiences, and investigates links between VExUS findings and clinical outcomes.
NCT07412366
Urea-to-Creatinine Ratio as a Marker of Metabolic Transition in Septic Shock: A Comparison with Indirect Calorimetry. This study investigates whether the urea-to-creatinine ratio can serve as a simple marker of metabolic state in patients with septic shock. Septic shock is associated with hypermetabolism and severe protein catabolism, which worsen outcomes. Although indirect calorimetry is the gold standard for measuring energy expenditure and metabolic demand in critically ill patients, its availability in ICUs is limited. The authors hypothesize that the urea-to-creatinine ratio reflects protein catabolism and correlates with energy expenditure measured by indirect calorimetry, making it a potential tool to identify the transition from the catabolic to the anabolic phase and to guide nutritional therapy. The primary objective is to assess the correlation between the urea-to-creatinine ratio and energy expenditure in septic shock patients. Secondary objectives include evaluating changes in systemic inflammation over time using C-reactive protein (CRP). This is a prospective observational cohort study of adult patients with septic shock admitted to a medical-surgical ICU who require at least three days of mechanical ventilation and undergo indirect calorimetry. Energy expenditure will be measured at predefined intervals during the ICU stay, while urea, creatinine, and CRP levels will be collected regularly. Patients with severe renal dysfunction, renal replacement therapy, or high oxygen requirements will be excluded. Data will be analyzed across three time periods during mechanical ventilation to examine trends in energy expenditure, urea-to-creatinine ratio, and inflammation. Demographic and clinical variables will also be collected. The study aims to determine whether changes in the urea-to-creatinine ratio mirror metabolic transitions detected by indirect calorimetry, potentially offering a practical alternative for metabolic monitoring in septic shock patients.
NCT01682590
The purpose of this multicentric, randomized controlled trial is to assess whether the timing of renal replacement therapy initiation (early vs delayed) has an impact on mortality at 90 days in patients with severe acute kidney injury at the failure stage (according to RIFLE criteria) during the initial phase of septic shock.
NCT07388628
The objectives of this registry study are to: 1. Record real-life data related to the use of the ARTICE® therapy in sepsis subjects. 2. Further evaluate ARTICE® treatment efficacy. 3. Identify potential sub-groups, assess their risk-benefit- and safety profile. 4. Changes in SOFA score D0 to SOFA Score D7.
NCT06394947
Fluids are considered the primary treatment for critically ill patients admitted to the intensive care unit (ICU), aiming to replace losses and or to enhance venous return, stroke volume, and consequently, cardiac output and tissue oxygen delivery. The modalities, volumes, and targets employed to titrate fluid therapy vary significantly in current clinical practice, as shown by the original FENICE study 10 years ago. FENICE studied how fluid challenges are given at the bedside. Very little is known about how this practice has changed since, how fluid administration (maintenance) is performed in general, and how the modality may impact outcomes. FENICE II is designed to explore these issues. Objectives: To provide a comprehensive global description of fluid administration modalities during the initial days of ICU admission and to explore any association between fluid administration characteristics and clinical outcomes. To describe the fluid challenge administration modality and appraise the use of variables and functional hemodynamic tests to guide bolus infusion.