View clinical trials related to Septic Shock.
Filter by:Septic shock is associated with a high mortality risk. Fluid overload occurs when fluids are administered to fluid unresponsive patients, but also when inappropriate resuscitation goals are pursued. Alongside, evidence confirms that abnormal peripheral perfusion after resuscitation is associated with increased morbidity and mortality. Targeted resuscitation associates with lower mortality, less organ dysfunction, and less intensity of treatment. Over-resuscitation may contribute to a worse outcome. Many patients remain hypovolemic after initial resuscitation. Others present very low diastolic arterial pressures (DAP) reflecting profound vasoplegia and may benefit from early norepinephrine (NE) instead of fluids. Administering fluids in this setting could increase the risk of fluid overload. In addition, relevant myocardial dysfunction is present in a significant number of patients. Pulse pressure (PP) and DAP evaluation may help clinicians to individualize initial management sparing unnecessary fluid loading. Objective: To test if a CRT-targeted resuscitation based on clinical hemodynamic phenotyping can improve a hierarchical clinical outcome - mortality, time to cessation of vital support, and length of hospital stay, all within 28 days - in septic shock patients as compared to usual care. A2 is a multicenter randomized controlled trial (RCT) comparing a CRT-targeted, hemodynamics-based resuscitation strategy with usual care in patients with early septic shock during a 6 h intervention period. A sample size of 1500 patients was calculated to detect a 6% absolute reduction in mortality in the CRT group, and the win-ratio method will be used to test the superiority in the hierarchical outcomes mentioned above. The combination of a CRT-targeted strategy with a clinical hemodynamic phenotyping may aid to personalize initial resuscitation with potential additional fluid-sparing effects. To categorize patients at baseline according to PP may conduct patients with low PP (<40mmHg) to fluid responsiveness (FR) assessment and eventually fluid boluses, while patients with normal PP will be treated according to DAP, adjusting NE when to avoid further fluids loading in patients who normalize CRT. Fluid resuscitation will be focused on FR+ hypoperfused patients to prevent harmful fluid administration in FR- patients.
The implementation of this project will improve the effectiveness of surgical treatment and reduce the level of complications and mortality among patients with heart failure and heart failure in the terminal stage. The goal of the study. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure. Objectives of the study. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and / or respiratory failure. Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis.
Septic shock is a common reason for admission to intensive care units and severe infections are responsible for 6 million deaths a year worldwide. Fluid management appears to be a major issue in resuscitation and particularly in septic shock, where generalised oedema is almost systematic and is a major factor in poor prognosis during sepsis. The formation of oedema corresponds to an imbalance, according to Frank-Starling's law of the heart, between the vascular compartment and the interstitial compartment, which is composed of the interstitial liquid and an extracellular matrix. This extracellular matrix consists essentially of a network of collagen and fibroblast fibres. Even though all of the plasma in the body transits through the interstitium in 24 hours and desite its major importance in the microenvironment and intercellular communication, the interstitial compartment has not been fully described. In oncology, interstitial tissue seems to contribute to tumour growth through changes in matrix composition and pressure in the interstitium. This pressure actively contributes to the regulation of transcapillary filtration, and thus to the oedema and hypovolemia observed during sepsis. In usual conditions, the fibroblasts exert a tension on the collagen fibres of the matrix via integrin Beta-1 (ITGB1). This tension is released under the action of pro-inflammatory mediators, resulting in negative pressure which potentiates the formation of oedema. It has been shown in an endotoxemia model that there is a thousandfold higher concentration of ITGB1 in the interstitium compared to the vascular compartment, suggesting a local secretion of this cytokine. The alteration of the extracellular matrix could also play a role in the perpetuation of oedema during septic shock. Considered as an organ in its own right, interstitial tissue is far from playing a passive role between the vascular compartment and the cells. The hypothesis is that interstitial fluid analysis could improve our understanding of the physiopathology of sepsis, in particular on the alteration of the mechanisms of fluid movement regulation, which remains very poorly understood while being closely associated with prognosis in patients with sepsis.
This study is a multi-center, randomized controlled feasibility trial to evaluate the initial safety and efficacy of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated shock across 15 U.S. sites. Adults (18 years old and older) admitted to the ICU with all of the following: • Pathogen associated shock defined as: - The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation - Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing
The benefit of low-dose steroids in septic shock is still debated today, especially with mineralocorticoids. Fludrocortisone is a synthetic mineralocorticoid, an analogue of aldosterone, which has shown, in combination with hydrocortisone, a favorable effect on the mortality of septic shock patients with relative adrenal insufficiency. In a previous study in healthy volunteers, we showed for the first time that fludrocortisone at a dose of 400 μg per day significantly improved the pressor response to phenylephrine. These results confirm the observations reported in rats with endotoxin shock, where fludrocortisone was shown to significantly increase blood pressure and contractile response to phenylephrine. These encouraging results argue for a potential vascular beneficial effect of fludrocortisone and need to be confirmed in a population of septic shock patients. In this context, we aimed to evaluate the effect of oral administration of 100 μg every 6 hours of fludrocortisone on vascular responsiveness to noradrenaline in septic shock patients.
Open-label phase 2a Randomized Controlled Trial (RCT) assessing the pharmacokinetics of two different doses of intravenous vitamin C given alongside vitamin B1 in adult medical patients with sepsis and hypotension.
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Intensive care unit (ICU) mortality in patients with septic shock and acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) remains high and approximates 50-60%. Sepsis is the leading etiology for AKI and CRRT requirement in ICU patients. In septic shock, the dysregulated host response to infectious pathogens leads to a cytokine storm with uncontrolled production and release of humoral pro-inflammatory mediators. These pro-inflammatory mediators and cytokines exert cellular toxicity and promote the development of organ dysfunction and increased mortality. In addition to treating AKI, CRRT techniques can be employed for adsorption of inflammatory mediators extracorporally using specially developed adsorption membranes, hemoperfusion sorbent cartridges or columns. Several methods and devices, such as Oxiris®-AN69 membrane, CytoSorb® cytokine hemoadsorption and polymyxin B (Toraymyxin) endotoxin adsorption and plasmapheresis have been evaluated in small study series but to date the data on outcome benefits remains controversial. HA380 (Jafron Biomedical Co , Ltd, Zhuhai, China) is a CE-labeled hemoadsorption cartridge developed to treat patients with septic shock. It contains hemo-compatible, porous polymeric beads that adsorp cytokines and mid-molecular weight toxins on their surface. The cytokines absorved using this cartridge are IL-1, IL-6, IL-8, IL-10 in addition to TNF-α8. Therefore, this study aims to examine the potential effects of cytokine adsorption using HA380 in addition to hemodiafiltration with the Oxiris®-AN69 membrane on ICU- and 90-day mortality in patients with septic shock and AKI.
Critically ill patients are prone to develop acute kidney injury due to sepsis itself and by administration of potentially nephrotoxic antibiotic treatment (vancomycin or gentamicin). Blood-specific miRNA levels associated with renal tubular damage change in patients treated with vancomycin or gentamicin compared to septic patients treated with other antimicrobials.
This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status.
Music intervention is a non-pharmacological and effective intervention that can alleviate anxiety and agitation in patients undergoing weaning. The effectiveness of music intervention in reducing anxiety of patients in Intensive Care Unit (ICU) is still unknown. The purpose of this study was to examine the effectiveness of music intervention on anxiety, agitation, sleep quality and physiological parameters on patients in ICU. This study was conducted from January to June 2019. A total of 196 hospitalized ICU patients were divided into two groups. Subjects in experimental group received 30 minutes music intervention for 3 days on bedside whereas subjects in control group received routine care only. The primary outcome was anxiety. Agitation Sedation Scale, sleep quality and physical parameters were selected to collect as secondary outcomes.There was no significant difference between the groups at baseline. The results of this study support that music can reduce anxiety and agitation levels in ICU's patient. Nurses can incorporate this intervention into the daily care in order to reduce the discomfort of patients.