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
Bell’s palsy or acute idiopathic lower motor neurone facial paralysis is characterised by sudden onset paralysis or weakness of the muscles to one side of the face controlled by the facial nerve. It is the third most common neurological reason for children to present acutely to hospital.
In adults, there is conclusive evidence from two major recent trials that a short course of prednisolone, a cheap, widely available and safe steroid, can significantly increase the number of Bell’s palsy patients who completely recover. While the medical problems associated with Bell’s palsy are similar, in children there is no good evidence that prednisolone is an effective treatment.
Many neurological conditions progress differently in children and treatment methods sometimes vary. Children may react differently to prednisolone and without paediatric evidence; treatment guidelines for children with Bell’s palsy remain absent or vague, with variable and overall low rates of steroid use in children by physicians.
The lack of evidence and clinical uncertainty in the treatment of Bell’s palsy in children warrants a definitive trial to determine the efficacy of prednisolone as a treatment for this condition in children. The aim of this study is to assess the utility of steroids in Bell’s palsy in children in a large multicentre randomised, placebo-controlled, trial. The trial will take place in at least 10 hospitals within Australia and New Zealand, involving more than 500 children.READ MORE
Ureteric colic (or Kidney stones) is a significant public health concern within Australia, affecting as many as 5-15% of adults. As a result, a significant number of Australians experience significant pain, hospital and outpatient visits, and the potential for more significant complications such as infection, kidney damage and the need for surgical treatments.
Although several methods of medical treatments to improve care of such patients have been studied overseas, some of which appear promising, the practice of “medical expulsive therapy” for ureteric colic is not widely practiced in Australia. One such medication is Tamsulosin, which seems to have an effect on the ureter (tube from kidney to bladder) and helps stones pass. It is already in use for other urological conditions already in Australia, and studies overseas seem to show benefit for patients with Ureteric colic.
Within Queensland Health there is substantial variation with regard to access to specialist urologist services. Benefits of medical therapies for ureteric colic may be even greater in geographically isolated areas without full time urology services.
Patients who present to the participating emergency departments with Ureteric calculi, that fit the inclusion criteria will be randomly allocated to either the study medication (Tamsulosin 0.4mg daily) or placebo. The patients will then be closely monitored for four weeks, to determine if the stones pass spontaneously, or if any complications occur. At four weeks the study will be complete, patients who are yet to have passed the stone, would be referred to Urology for consideration of a procedure.READ MORE