View clinical trials related to Shock, Septic.
Filter by:Septic shock continues to exert a large economic burden around the world. Several developments have occurred that lead to the current study. First, angiotensin II is the newest FDA approved vasopressor agent indicated for use in vasodilatory shock. Several subgroups from the approval trial have indicated that angiotensin II may confer a survival benefit in certain conditions, including those patients requiring continuous renal replacement therapy, those with altered angiotensin I: angiotensin II ratios, and most recently, those with elevated renin levels (which may serve as a surrogate for dysfunctional angiotensin 1: angiotensin II ratios). This open-label, sequential period pilot study will evaluate angiotensin II and biomarker response (renin) in the treatment of septic shock.
this study is conducted to evaluate the role of the novel triple therapy combination in reducing the mortality rate, reducing the shock time, and reversal of organ damage. the study includes two arms, the first arm is the control which received hydrocortisone monotherapy and the second arm is the intervention arm which received the triple therapy regimen. calculation of 28 days in-hospital mortality is the primary outcome. shock time, vasopressor doses, infection markers, and organ function tests are the secondary outcomes. the data will be analyzed by student t-test or Mann Whitney test, Fischer exact or chi-square test for numbers, repeated measures ANOVA will be used to consider confounders and other parameters, mortality will be expressed by Kaplan Meier and ROC curve. For Multivariate analysis of repeated quantitative outcomes, linear mixed models were used to quantify the relationship between one dependent variable (SOFA, SCr, doses of vasopressors) and many independent variables including group type and sepsis phenotype adjusted to other clinical and demographic factors.
The purpose of this study is to determine the most suitable dose of Fludrocortisone in reversal of sepsis and shock associated with sepsis in patients who are admitted to the ICU. The investigators will be looking to see whether patients receiving Fludrocortisone at different doses recover quicker and spend less time in hospital and in ICU, and to understand the reasons why this happens at certain doses. Sepsis is caused by toxic substances (toxins) from bacteria and other organism entering the bloodstream from a site of infection. In some people, the infection can progress to sepsis and septic shock where the functions of organs in the body are affected. Patients suffering from sepsis and septic shock are commonly managed in the intensive care unit (ICU) where they are prescribed antibiotics as standard therapy, as well as other therapies to support the functions of the body. Fludrocortisone is a steroid that has previously shown to be beneficial to help in shock in patients in ICU, but more information is required about the exact dose that is required to achieve this. This has been shown by previous research. However, the exact role of Fludrocortisone and the best dose has not been studied adequately to date as well as the ways in how it works within the body. The study aims to look tat the dose and the way it works.
During Infection, oflfending microbes interact with the host immune system producing a downstream inflammatory cascade involving cytokines and other mediators, which in turn triggers a systemic response. The resultant effects linclude vasodilation, increased vascular permeability, myocardial depression, and impairment of the coagulation cascade, resulting in global imbalance of systemic oxygen supply and demand. During the late stage of sepsis, immunosuppression predominates, leading to multi-organ dysfunction and further clinical deterioration . Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection with two or three on Quick Sepsis-related organ failure assessment score (qSOFA). Septic shock is defined as the presence of sepsis and refractory hypotension to fluid management. Vasopressors are needed to maintain systolic blood pressure more than 90mmHg or mean blood pressure more than 65 mmHg . Experimental and Clinical evidence suggests that sepsis is associated with dysregulated response of Hypothalamic-pituitary-adrenal axis that may involve any of the steps from cortisol production to cortisol use by cells . Glucocorticoid therapy for the treatment of septic shock remains controversial, with conflicting evidence regarding a mortality benefit. It has been used in patients with septic shock who remained hypotensive after fluid and vasopressor resuscitation. Fludrocortisone is a corticosteroid and acts as a powerful mineralocorticoid along with some additional but comparatively very weak glucocorticoid activity. Relative to cortisol, it is to 10 times the glucocorticoid potency but 250 to 800 times the mineralocorticoid potency . Fludrocortisone is added to hydrocortisone to provide additional mineralocorticoid potency. The rationale for adding mineralocorticoid treatment is that an experimental sepsis study showed marked nuclear factor NF-κB mediated down regulation of vascular mineralocorticoid receptors . Corticosteroids attenuate inflammation in various organs an effect partly related to inhibition of nuclear factor NF-κB. Improve cardiovascular function by restoring effective blood volume through increased mineralocorticoid activity and by increasing systemic vascular resistance through vascular α-Adrenergic responsiveness and reduces inflammation-mediated vasodilation .
Fluid responsiveness prediction prior to fluid challenge administration is a topic of interest, which has been extensively investigated, but remains challenging. In clinical practice, functional hemodynamic tests (FHT) consisting of maneuvers that affect cardiac function and/or heart-lung interaction, have been introduced in order to identify fluid responders and non-responders without fluid challenge administration. Changes in cardiac output induced by the Passive Leg Raising (PLR) test reliably predicted the increase in cardiac output to volume expansion. New approaches have been recently developed based on changes in respiratory dynamics, such as a transient increase in tidal volume, or a lung recruitment maneuver or an end-expiratory occlusion (EEO) test. The EEO leaded to an increase in venous return, cardiac preload and stroke volume in preload-responsive patients. The authors found that an increase in cardiac output ≥ 5% during a 15-s EEO reliably predicted its response to a 500-ml saline infusion. However, in order to identify the rapid and transient increase in cardiac index during the EEO, continuous and instantaneous cardiac output monitoring is necessary. Pulse contour analysis methods provide a beat-to-beat estimation of cardiac output and had been used in most of studies validating the EEO test. Carotid doppler is a non-invasive, bedside, easy to use ultrasound technique that measuring blood flow peak velocity (CDPV) and duration of systolic component of each cardiac cycle (from the onset to dicrotic notch- Flow time - FT) allows a reliable estimation of fluid status and could be an interesting alternative to track changes in SV and cardiac output.
The sepsis and septic shock remain major causes of child morbidity and mortality, despite the use of modern antibiotics and resuscitation therapies. Recent interest has focused on biomarkers for early diagnosis, and evaluation the outcomes of sepsis; but there is a still lack of early diagnosis and timely intervention for sepsis in the emergency department (ED). The primary aim was to investigate the role of C-Reactive Protein(CRP), Procalcitonin(PCT), soluble-urokinase plasminogen activator receptor(suPAR) and Presepsin in the early stratification of patients with sepsis. The usefulness of pediatric Sequential Organ Failure Assessment (pSOFA) for predicting of the mortality and the rate of PICU admission in children with septik shock were also investigated. This prospective pilot study was conducted at academic pediatric ED between September 2017-June 2018. All children who met sepsis criteria admitted to ED were involved to study. They kept following up after ED management and their blood samples were taken upon admission on day 0, 1, 2, 4 and 7. The definition made as sepsis, severe sepsis and septic shock. At the same period, 100 healthy children chosen as the control group. The patient characteristics, clinical features, diagnosis, co-morbidities, source of infection, laboratory results (CRP, PCT, lactate, suPAR and Presepsin) and treatments were recorded. The pSOFA score was calculated during first hour of admission. Length of stay in ED and hospital was noted. The main outcome measure was in 7 and 30-day mortality.
Septic shock is a subset of sepsis characterized by a decrease in vascular tone, which contributes to impaired regional blood flow distribution, and leads to organic failure. Besides intravenous fluids and adequate antimicrobial therapy, patients with septic shock require vasopressor support, which can lead to many adverse effects, therefore, non-vasopressor agents that can improve hemodynamic status are needed. In this randomized controlled-study, the investigators will address the efficacy and safety of infusion with methylene blue in patients with septic shock.
This is a single center, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on generally healthy adults representative of the US population.
Although norepinephrine is commonly used and is the recommended agent for the treatment of hypotension in volume-resuscitated hyperdynamic septic shock, Low doses of vasopressin may be added to norepinephrine to maintain arterial blood pressure in refractory septic shock and to decrease exposure to norepinephrine. The aim of the work is to compare the effect of norepinephrine alone and Norepinephrine/vasopressin combination on hemodynamics and tissue perfusion in septic shock patients.
Sepsis is defined by the occurrence of critical organ dysfunction in the context of infection. Unfortunately, its incidence appears to be rising, and the mortality of septic shock remains extraordinary high (> 60%). Death in sepsis arises from shock and multi organ dysfunction that are - at least in part - triggered by an inadequate response of the host's immune system to the infection. Given the injurious role of 1) this overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vWF cleaving proteases, hemostatic factors etc.) while the disease is progressing the investigators hypothesize that early therapeutic plasma exchange (TPE) in the most severely ill individuals might improve hemodynamics, oxygenation and ultimately survival. This therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of protective plasma proteins. The investigators designed the EXCHANGE trial to analyze in a randomized fashion the benefit of TPE as an add-on treatment to state of the art standard sepsis care. Only patients with early septic shock (< 24 hrs) and high catecholamine doses (norepinephrine > 0.4 ug/kg body weight/min) will be included. Those in the treatment group will receive 1 TPE within 2 hours following randomization. The primary outcome is norepinephrine dose 6 hrs after randomization. The recruitment period is 2 years and will be performed at the Hannover medical School University hospital in Germany. Secondary endpoints (including organ dysfunction as well as biochemical markers of inflammation and coagulation) will be assessed on day 1-8 and day 28 after TPE. The investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from septic shock.