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
Acutely agitated patients are commonly seen in the emergency department (ED). As these patients may cause harm to themselves or others, a large proportion need to be managed with injectable sedative medications such as benzodiazepines (eg midazlolam) and/ or antipsychotics (e.g droperidol).
Unfortunately, these medications may precipitate life threatening events (e.g hypoventilation). Safety data related to the use of these medications for the management of acute agitation in the ED setting are scant. Acute agitation in the ED setting is usually caused by mental health issues or substance abuse, again little is known about which sedative medications are best suited for different groups of acutely agitated patients.
The aim of this study is to determine the nature and incidence of adverse events associated with parenteral sedation medication administered to acutely agitated patients in the ED and to determine the risk factors for these adverse events. It is a multicentre national observational study, aiming to recruit 2000 patients over the age of 18, over a 2 year period. It is hoped that the evidence this study generates will define the risk of AE in this population and may guide clinicians in future treatment choices in sedating this challenging group of patients, hopefully reducing future AE.READ MORE
This project aims to determine if the drug combination called ketafol offers an improved safety profile while maintaining the same procedural success rates and patient satisfaction. This study will still treat any pain before the procedure starts or the sedative drugs are administered for the procedure itself. Patients who agree to take part will receive one or other of the alternatives in predetermined amounts. All patients receive full monitoring and standard sedation care.
The second aspect to this study relates to the way in which the data will be viewed and analyzed. This study will be using a special database with visual interfaces that allows analysis of the data and comparison to what is already known about patients who have had procedural sedation in other studies.READ MORE