The aim of this study was to determine whether 4% albumin solution is superior to saline for fluid resuscitation of patients presenting to the emergency department with septic shock.READ MORE
The question of fluid volume in resuscitation has been identified as the top priority in sepsis research by emergency physicians in the United Kingdom, Australia and New Zealand. Guidelines and sepsis pathways recommend an initial intravenous (IV) fluid bolus of 30ml/kg isotonic crystalloid for patients with sepsis and hypotension. However, there is a lack of evidence from clinical trials to support this strategy. Both observational data as well as randomised studies suggest there may be harm associated with injudicious use of fluids in sepsis. Since there is equipoise regarding a more liberal or restricted fluid volume resuscitation as first line treatment for sepsis-related hypotension, we conducted the pilot multicentre REstricted Fluid REsuscitation in Sepsis-associated Hypotension (REFRESH) trial comparing a restricted fluid protocol with early initiation of vasopressor support against standard guideline care.
The data from REFRESH will inform feasibility of a large, multicentre phase III study. However, further ground work is essential for the optimal design of a Phase III trial that will provide valuable information on feasibility (road test recruitment rate and screening processes) as well as refinement of the protocol (sample size estimation, processes of care, prevalence of the population of interest, real world clinical practice regarding fluid use).
In this ARISE Fluids study, we aim to provide more insight into current practice by conducting a bi-national multi-site prospective observational study of fluid administration in (suspected) sepsis and hypotension in the Emergency Departments of Australia and New Zealand hospitals. Sites have been selected on the basis of having expressed interest in participating in a phase III trial.READ MORE
Not infrequently, doctors working in the Emergency Department (ED) have to decide on how they are to provide treatment to dying patients. Specifically, they have to decide whether to actively treat or whether they should limit or withdraw treatment on patients who are not anticipated to live. Such decisions should be governed by legislature as well as standards set by the Australian Council on Health Care Standards (ACHCS). However, research conducted in our hospital has indicated that doctors consider a wide variety of factors including patient’s and family’s wishes when making such end-of-life decisions. We therefore raise the following questions. First, what factors do doctors take into account when they withdraw or withhold treatment in the ED? Second, are such decisions made in accordance with legislative requirements? To date, no research has examined this issue.
This study addresses this gap by focussing on the decisions leading to withdrawal of treatment in the ED. It is a multi-centre review of patients who die in 2009 in a number of Australian and New Zealand hospitals. The primary aim is to describe the factors that doctors consider when making the decisions to withdraw or withhold life-sustaining treatment. The secondary aims are to determine 1) whether Australian doctors are conducting such processes in line with ACHCS guidelines and 2) whether Queensland doctors are making such decisions in accordance with Queensland legislation.READ MORE
The REFRESH study is a multicentre, open-label, randomised, phase II clinical feasibility trial. This is the first randomised trial examining fluid volume for initial resuscitation in septic shock in an industrialised country. A pragmatic, open-label design will establish the feasibility of undertaking a large, international, multicentre trial with sufficient power to assess clinical outcomes. The embedded biomarker study aims to provide mechanistic plausibility for a larger trial by defining the effects of fluid volume on markers of systemic inflammation and the vascular endothelium.
Participants will be patients presenting to the emergency departments of Australian metropolitan hospitals with suspected sepsis and a systolic blood pressure of < 100 mmHg, persisting after a 1000-ml fluid bolus with isotonic crystalloid. Participants will be randomised to either a second 1000-ml fluid bolus (standard care) or maintenance rate fluid only, with the early commencement of a vasopressor infusion to maintain a mean arterial pressure of > 65 mmHg, if required (restricted fluid). All will receive further protocolised fluid boluses (500 ml or 250 ml, respectively), if required during the 6-h study period. The primary outcome measure is total volume administered in the first 6 h. Secondary outcomes include fluid volume at 24 h, organ support 'free days' to day 28, 90-day mortality, and a range of feasibility and process-of-care measures. Participants will also undergo serial measurement, over the first 24 h, of biomarkers of inflammation, endothelial cell activation and glycocalyx degradation for comparison between the groups.READ MORE
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