View clinical trials related to Shock, Septic.
Filter by:The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results in the best outcomes for children treated for suspected or confirmed septic shock. In this study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock Resuscitation Guidelines, with the assigned resuscitation strategy used to guide administration of further fluid boluses as well as the timing of initiation and escalation of vasoactive medications to achieve ACCM recommended hemodynamic targets.
Septic shock is a highly lethal condition associated with a mortality risk of 30 to 60%. Optimizing tissue perfusion and oxygenation is the aim to decrease mortality and morbidity in septic shock patients. Persistent hyperlactatemia after initial resuscitation is particularly difficult to interpret, although optimizing systemic blood flow might reverse ongoing hypoperfusion. Nevertheless, if persistent hyperlactatemia is caused by non-hypoperfusion-related mechanisms, then sustained efforts aimed at increasing cardiac output (CO) could lead to detrimental effects of excessive fluids or inotropes. Another potential alternative resuscitation target is peripheral perfusion as assessed by capillary refill time (CRT), mottling score or central-to-toe temperature differences. Reversal of abnormal peripheral perfusion might represent improvement in tissue hypoperfusion with the advantage of a faster recovery than lactate. Hypothesis: Peripheral perfusion guided resuscitation in septic shock is associated with lower mortality, less organ dysfunctions, less mechanical ventilation (MV), less vasopressor load, and less renal replacement therapies than a lactate-targeted resuscitation strategy. Main Objective To test if peripheral perfusion targeted resuscitation in septic shock is associated with lower 28-day mortality than a lactate targeted resuscitation. Design: Multicenter, Parallel Assignment randomized controlled study, conducted under supervision of an independent Data Safety Monitoring Board (DSMB). Interventions: 1. Active Comparator- Peripheral Perfusion guided resuscitation 2. Active Comparator- Lactate guided resuscitation Randomization: 1:1 the randomization using a block size of eight will be stratified according to participating centers. Trial size: 400 randomized patients in 30 ICUs.
Sepsis is defined by the occurrence of a systemic inflammatory response syndrome (SIRS) 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 (< 12 hrs) and high catecholamine doses (noradrenaline > 0.4 ug/kg bodyweight/min) will be included. Those in the treatment group will receive 3 TPEs within three consecutive days. The primary outcome is 28-day all cause mortality. To show an assumed reduction from 60% to 45% in the experimental group, a sample size of 173 patients per group has been calculated. The overall sample size is therefore n=346. The recruitment period is 3 years (+3 months observation) and will be performed in 11 national centers in Germany. Secondary endpoints (including hemodynamics, oxygenation, coagulation, and microcirculation) will be assessed on day 1, 2, 3 before and after TPE and on day 4, 5, 7 and 14. Project management and data monitoring will be organized by the Hanover Clinical Trial Center and biostatistics including a web-based randomization will be performed by the Institute of biometrics (Prof. Koch) at Hannover Medical School. The investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from an under-recognized but deadly disease.
In critically ill children with severe sepsis, neurophysiologic derangements often proceed undetected and can lead to irreversible brain injury causing neurocognitive and behavioral deficits. The etiology of these impairments is unclear, however, it is likely that some of this neural injury is preventable. The overarching goal for this study is to show that acute acquired structural and microstructural brain injury occurs in critically ill children with severe sepsis, and that this injury is related to neuropsychological deficits and impaired cerebral autoregulation (CAR). Subjects will complete Magnetic resonance (MR) imaging within 2-10 days of recognition of their severe sepsis. Subjects will undergo serial interrogation of CAR for up to 10 days. CAR will be determined by the correlation of arterial blood pressure with middle cerebral artery flow velocity measured by transcranial doppler ultrasonography and cerebral oximetry derived from near-infrared spectroscopy. Subjects will also participate in a neuropsychological evaluation 6 months after enrollment to evaluate multiple domains of behavior and cognition.
The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6 hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock with catecholamine resistance has been studied such as terlipressin, methylene blue - Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C, and increases intracellular Ca2+ concentration - Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme guanylate cyclase (GC)
Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom administered in intensive care due to a dose dependent toxicity published in case reports and unfavourable outcome reported in a few prospective trials done on cardiology patients. The papers on 1c class antiarrhythmics do not take into consideration a complex haemodynamic assessment using echocardiography. The authors have recently presented a retrospective study on SV arrhythmias in septic shock patients demonstrating favourable effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.
The primary aim of this study is to evaluate the 30-day mortality outcome of the septic shock patients who are treated with ultrasound-assisted fluid management using change of the inferior vene cava (IVC) diameter during respiratory phases in the first 6 hours compared with those treated with "usual-care" strategy.
This is a prospective observational cohort trial evaluating a single plasma vasopressin concentration in patients receiving exogenous, adjunctive vasopressin for septic shock. The trial is designed to determine whether plasma vasopressin concentration influences the likelihood of hemodynamic response to exogenous vasopressin therapy.
Anticholium® per Se is a randomized, double-blind, placebo-controlled, monocentric trial to assess whether the CAP can be transferred from bench to bedside. In this pilot study, 20 patients with perioperative sepsis and septic shock as a result of intra-abdominal infection are enrolled. According to randomization, participants are treated with physostigmine salicylate (verum group) or 0.9% sodium chloride (placebo group) for up to 5 days. The mean Sequential Organ Failure Assessment (SOFA) score during treatment and subsequent intensive care of up to 14 days is used as surrogate outcome (primary endpoint). Secondary outcome measures include 30- and 90-day mortality. An embedded pharmacokinetics and pharmacodynamics study investigates plasma concentrations of physostigmine and its metabolite eseroline. Further analyses will contribute to the understanding of the role of various cytokines in the pathophysiology of human sepsis. A computer-generated list is used for blocked randomization.
With a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System) it is possible to optimize the initial antimicrobial therapy in patients with sepsis and septic shock. Prospective observational, open-label mono-center study to compare a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System and Curetis Univero System) with standard blood culture diagnostics in patients with sepsis or septic shock.