View clinical trials related to Shock, Septic.
Filter by:The current guideline emphasizes fluid resuscitation as the mainstay of initial management for septic shock. Albumin has the oncotic activity to maintain intravascular volumes with additional beneficial properties in sepsis. Prior studies showed that the replacement of albumin might have survival advantages in patients with septic shock. The investigators aim to assess whether the early administration of albumin with crystalloid as initial fluid resuscitation improves survival in patients with septic shock compared to resuscitation without albumin.
In this prospective, multicentered , diagnostic trial, nasal and fecal specimens will collected from patients with sepsis in two critical care units(ICU) at the enrollment day ,the third, seventh, and fourteen days after enrollment or until ICU discharge (whatever come first). Total DNA from the nasal and fecal specimens will be extracted, amplified, and sequenced to determined the characteristics of gut microbiota and nasal microbiota. Finally, the characteristics of gut microbiota and nasal microbiota combined clinical information will be used to construct a prediction model to predict the prognosis of sepsis.
Sepsis and septic shock are major causes of ICU admission worldwide. Despite recent advances in treatment, including targeted resuscitation and timely use of antimicrobial agents, mortality of ICU patients with septic shock remains steadily high. Especially in those requiring high dosage of vasopressors, whose 28-day mortality rate could reach 60%. The pathophysiology of septic shock emphasizes on the role of dysregulated host immune response towards inciting microbes, producing excessive inflammatory cytokines which lead to tissue damage and subsequent organ failures. Multiple therapies targeting the overwhelming inflammatory response in patients with septic shock have been studied (ref). While some showed promising results in modulating inflammation in observational studies (ref), none other than systemic corticosteroids lead to better clinical outcomes in the randomized controlled studies. The reasons for their failures are the complexity of the inflammation cascades, where treatments specifically targeting parts of the process may not be able to achieve meaningful effects. Extracorporeal blood purification therapy is an adjunctive treatment option more extensively studied over the last decade. By passing patients' blood or plasma through specifically developed absorber, various inflammatory cytokines are absorbed to resins inside the devices and removed from the circulation. Decreasing levels of inflammatory cytokines may subsequently attenuate systemic inflammation leading to shock reversal and better survival. HA-330 disposable hemoperfusion cartridge (Jafron®, China) is an absorber targeting hyper-inflammatory states including septic shock. It is designed to nonspecifically absorb molecules with molecular weight 10-60 kilo-Dalton, making it effective for removing various pro-inflammatory cytokines and potentially modulating the inflammatory cascade. Previous randomized study in patients with sepsis compared between the add-on 3 daily session of hemoperfusion with HA-330 adsorber and the standard therapy . .Circulating interleukin-6 and interleukin-8 levels of patients underwent hemoperfusion significantly reduced after two sessions when compared to baseline. Their values on day 3 were also significantly lower than those of the control group. Adjunctive hemoperfusion were associated with lower ICU mortality, butno significant difference in hospital and 28-day mortality between the two groups(ref). However, approximately 50% of enrolled patients had sepsis without shock. Generalization of the findings to more severe cohorts of septic shock patients are therefore limited. Patients with septic shock have higher cytokines level than septic patients without shock. Hence, they are theoretically more likely to benefit from therapies aiming to reduce cytokine levels. We hypothesize that adjunctive hemoperfusion with HA-330 adsorber would be associated with better outcomes in a more severe group of patients with septic shock.
Sepsis is one of the most serious healthcare problems, worldwide, and financial burdens. The overall mortality of severe sepsis/septic shock was 44.5-52.6%. A common cause of death is refractory shock and multi-organ failure. Myocardial dysfunction is a relatively common complication of septic shock. This causes a decrease in the amount of cardiac output, resulting in insufficient blood supply to the organ and multi-organ failure and lead to death Early goal-directed therapy began to use dobutamine in patients with septic shock Sepsis Survival Campaign Guideline 2016 recommended drug is dobutamine and an alternative drug is milrinone in septic shock patients with clinical signs of poor tissue perfusion.
Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock
Burden: The global burden of sepsis is difficult to ascertain, although a recent scientific publication estimated that in 2017 there were 48.9 million cases and 11 million sepsis-related deaths worldwide, which accounted for almost 20% of all global deaths. Recent chart analysis from Dhaka Hospital, icddrb recorded 350 adults with severe sepsis admitted over four years. Among them, 69% of patients progressed to septic shock. Knowledge gap: Clinical features of shock due to sepsis and shock due to severe dehydration are very intertwining and often predicament for critical care physicians. If not recognized early and managed promptly, it can lead to septic shock, multiple organ failure, and eventually death. Serum lactate may play a role as the point of care test in differentiating shock due to severe sepsis from shock due to severe dehydration. Relevance: Being the largest diarrhoeal disease hospital, the Dhaka Hospital of icddr,b is ideal for researching shock with diarrheal diseases. Even though the onset of sepsis can be acute and poses a short-term mortality burden, it can also cause significant long-term morbidity, requiring treatment and support. Thus, addressing sepsis and severe sepsis by early detection and prompt management should be a comprehensive way to reduce the burden in our community.
The investigators propose to conduct a multi-center randomized pilot feasibility trial comparing therapeutic plasma exchange to standard of care in patients diagnosed with septic shock.
Background and Rationale: Sepsis is a universal healthcare problem with a high incidence and mortality. Improvement in early sepsis recognition and management has reduced the 28 day- and in-hospital mortality in the last two decades. Mortality rates from sepsis ranges from 20% to 30% of which one-third occurs within 3 days of ICU admission. Identifying patients with sepsis or septic shock who are at increased risk of early death can direct the priority of care for these patients and assist in predicting who is most likely to benefit from higher levels of care. In addition, this can encourage for direct future clinical trials to investigate new therapeutic interventions. Despite the large body of research on biomarkers (e.g. Serum lactate, interlukins) and clinical prediction tools (e.g. mSOFA score, APACHE II) for rapid risk stratification and in-hospital mortality of septic patients, the early identification of patients at increased risk for clinical deterioration remains challenging and the data on predictors of early death in septic patients remains deficient. Persistently low MAP or DAP have been related to worse outcomes in septic shock, this was aggravated by the new-onset prolonged sinus tachycardia which occur as a result of sympathetic activity. This associated tachycardia has been linked to increased major cardiovascular events, prolonged length of stay and higher mortality rates The recent study by Ospina-Tascón et al. presented a novel index, the "diastolic shock index" (DSI), defined as the ratio of heart rate (HR) and diastolic arterial pressure (DAP). They studied the diastolic shock index relation to clinical outcomes in patients with septic shock. In their study, this index represented a very early identifier of patients at high risk of death within 28 days and 90 days after admission, while isolated DAP or HR values did not clearly identify such risk. A few previous studies focused on the comparison between shock indices for prediction of sepsis outcomes and their results had a preference for DSI and MSI over SI.In this study we defined early mortality as that will occur within 3 days from admission or start of septic shock. This definition was based on previous works performed in patients with septic shock, for whom trends in organ failures during the first 3 days in the ICU were found accurate predictors of outcome . However, almost no study focused on the ability of the diastolic shock index to predict early ICU mortality from sepsis within 72 hours from admission. So, this study aims to fill this gap in the literature. Objectives : to investigate the ability of the diastolic shock index to predict early ICU mortality from sepsis within 72 hours from admission
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.
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.