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Showing 1-20 of 332 trials
NCT07482865
A prospective, multi-center, open label, randomized controlled, superiority trial to compare clinical outcomes between routine distal perfusion catheter (DPC) insertion versus provisional distal perfusion catheter (DPC) insertion in the occurrence of sign or symptom of acute limb ischemia in patients undergoing mechanical circulatory support (MCS) through femoral artery approach.
NCT06650501
This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking oral anticoagulant medications (apixaban, edoxaban, or rivaroxaban) for an approved indication (stroke prevention in atrial fibrillation, prevention or treatment of venous thromboembolism). We will randomize patients to continue their existing medication or change to another medication (dabigatran) which is approved for the original indication. Dabigatran is approved in many countries for the treatment or prevention of venous thromboembolism or preventing stroke in atrial fibrillation. Unlike the other medications listed above, dabigatran seems to have activity against S. aureus in the test tube, in animal models, and in a smaller randomized controlled trial. We wish to determine if changing to dabigatran will improve outcomes in S. aureus bacteremia in people who otherwise would have a reason to be taking it. This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119). If positive, this study will support a second RCT in people who do not currently have an indication for anticoagulation.
NCT04419480
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
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.
NCT06965504
The study will evaluate if Impella 5.5® support in heart failure reduced ejection fraction (HFrEF) patients presenting with decompensated heart failure (HF) and cardiogenic shock will facilitate the initiation and optimization of guideline directed medical therapy (GDMT) during the hospital stay and post-discharge.
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.
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.
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.
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.
NCT03953677
Septic shock is common in patients admitted to intensive care and hospital mortality occurs in close to 50% of these patients. In half of the cases, death occurs within the first 72 hours in a context of multiple organ failure that does not respond to conventional therapies, particularly circulatory therapies, despite increasing doses of catecholamines. Vasopressor resistance in septic patients defines refractory septic shock. In one study (Conrad et al. 2015), the increase in blood pressure observed with an infusion of increasing doses of phenylephrine (dose-response curve) made it possible to quickly and clearly identify patients resistant to vasopressors at a high risk of death by refractory shock (ROC AUC 0.92). This resistance is due in particular to a downregulation of α1 adrenergic receptors, linked to sympathetic hyper activation associated with septic shock. To date, there is no validated therapy in this situation. However, experimental data have shown that the administration of α2 agonists, usually used for their sedative (dexmedetomidine) or anti-hypertensive (clonidine) effect, normalizes sympathetic activity towards basal values. In animals, α2 agonists restore the sensitivity of alpha1 adrenergic receptors, resulting in improved vasopressor sensitivity and survival. In humans, a beneficial effect on mortality was suggested in the first trial testing dexmedetomidine in septic patients in 2017. This effect was observed especially in the most severe patients, suggesting a restoration of sensitivity to vasopressors. The hypothesis is that the administration of dexmedetomidine in patients in refractory septic shock may improve response to phenylephrine and decrease resistance to vasopressors. This pilot study could lay the foundation for a randomized controlled trial.
NCT06464510
The norepinephrine and vasopressin for rescue versus early vasopressin for vasopressor dependent sepsis (NoVa) is a phase 3, multicenter, open-label, randomized controlled trial comparing an early vasopressin initiation strategy versus norepinephrine plus vasopressin initiation only as a rescue strategy for hemodynamic management of critically ill patients with vasopressor dependent sepsis.
NCT06080074
There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to: 1. To evaluate the safety and effectiveness of the Cardiohelp Device for VA-ECMO (heart-lung support) for up to 30 days of support in children with severe heart failure with the goal to support its FDA clearance in children. 2. To evaluate heparin versus bivalirudin as the primary blood thinner (anticoagulant) in a randomized trial of children supported with the Cardiohelp ECMO System with the goal to plan a phase III (pivotal) randomized clinical trial The main questions the Cardiohelp single-arm trial seeks to answer are: * What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO? * Should the Cardiohelp device be FDA-cleared for children based on the results of the study? * What are the optimal performance specifications of the Cardiohelp device in children? The main questions the blood thinner randomized trial seeks to answer are: * Which blood thinner is more promising (i.e., more effective and safer) in children on the Cardiohelp device? * How should a pivotal trial of heparin vs. bivalirudin be designed so it is the most informative and efficient to determine the best blood thinner? Children who are receiving the Cardiohelp device will be approached and consented to participate if interested. For the Cardiohelp device trial, participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. For the blood thinner randomized trial, participants will be randomized 1:1 to blood thinner strategy to determine which blood thinner has the fewest bleeding and clotting complications. For the Cardiohelp single-arm trial, participant outcomes will be compared to performance goals (PG) derived from the ECMO literature. For the blood thinner randomized trial, the amount of bleeding and clotting will be measured. The study is funded by an R01 grant from the FDA's Office of Orphan Product Development (OOPD).
NCT05443321
Sub-optimal transfer of clinical information during inter-hospital transfer (IHT, the transfer of patients between acute care hospitals) is common and can lead to patient harm. To address this problem, the investigators will use key stakeholder input to refine and implement an interoperable health information exchange platform that integrates with the electronic health record and improves the reliability of and access to necessary clinical information in three use cases involving transfer of patients between sending and receiving hospitals with varying levels of affiliation and health record integration. The investigators will assess the effect of this intervention on frequency of medical errors, evaluate the use and usability of this platform from the perspective of those that interact with it, and use these results to develop a dissemination plan to spread implementation and use of this platform across other similar institutions.
NCT07343206
The goal of this clinical trial is to determine whether early initiation of norepinephrine with rapid dose adjustment improves clinical outcomes in adult patients with septic shock. The study aims to evaluate the effect of early norepinephrine administration on mortality, hemodynamic stabilization, and resuscitation efficiency in adults aged 18 years and older diagnosed with septic shock. The main questions it aims to answer are: * Does early norepinephrine administration with rapid dose titration reduce 28-day mortality compared with standard treatment? * Does early norepinephrine administration with rapid dose tiration lead to faster shock control and reduced fluid requirements without increasing treatment-related adverse events? Researchers will compare early norepinephrine administration with rapid dose adjustment to placebo with standard sequential resuscitation and rescue norepinephrine as needed to see if early vasopressor initiation improves survival, shock resolution, and safety outcomes. Participants will: * Receive either norepinephrine or placebo infusion initiated within one hour of septic shock diagnosis, with dose adjustment every 15 minutes according to a standardized protocol * Undergo close hemodynamic and safety monitoring, including frequent vital sign assessment and limb perfusion evaluation * Receive standard sepsis care, including fluid resuscitation, antibiotics, and organ support as clinically indicated * Be followed for clinical outcomes and adverse events for up to 28 days after enrollment
NCT07351435
The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing VV, VA or VAV ECMO implantation in the French West Indies and Guiana. All patients undergoing ECMO implantation will be prospectively registered.
NCT04972526
The general objective of this study is to evaluate the clinical impact and safety of focused, point-of-care transesophageal echocardiography (TEE) used during the evaluation of critically-ill patients in the emergency and intensive care settings. The target population for this study are critically-ill patients over the age of 18 who as part of their routine clinical care are receiving a focused TEE. The primary objective of this study is to determine the clinical impact and safety of TEE performed during the evaluation of critically-ill patients in the emergency department and intensive care settings. The secondary objective(s) of this study are to characterize the use of this imaging modality in the subsets of critically-ill patients in shock and cardiac arrest; including but not limited to; description of the frequency of studies, clinical indications, clinician characteristics, echocardiography findings, timing of studies, procedure-related complications and patient outcomes.
NCT03901807
Prospective, multicenter, randomized, open-label study of standard of care plus the PMX cartridge versus standard of care alone in patients with endotoxemic septic shock
NCT07264543
The aim of the study is to evaluate the viability and feasibility of its protocol in order to conduct a larger clinical trial to assess whether methylene blue can improve patient-centered clinical outcomes such as mortality or length of hospital stay in septic shock patients.
NCT07296029
This study is designed to assess the feasibility of identifying and administering individualized blood pressure targets early critical illness. Recent literature suggests that individualized targets adapted to cerebral perfusion and autoregulation capacity may improve patient outcomes. In this study, cerebral autoregulation capacity is assessed by simultaneous trending of near-infared spectroscopy and arterial blood pressure for 24 hours, within patients' first 2 days in the ICU. The investigators will assess the feasibility of identifying patients' personal targets, then treating patients according to their personal targets for 48 hours. Clinical outcomes explored will include delirium.