Sepsis is a leading cause of death and disability in children, globally accounting for more than one million childhood deaths per year. Recommended sepsis treatment currently consists of intravenous antibiotics and aggressive fluid boluses followed by inotropes and consideration for intravenous steroids. However, the evidence for interventions other than antibiotics is limited and aggressive fluid administration may be associated with harm. Therefore, fluid-sparing algorithms using early inotropes to treat shock have been proposed. Another strategy to hasten shock resolution consists in intravenous steroids, alone or in combination with thiamine and vitamin C, postulated to support metabolic dysfunction in recent studies.
In this project, the research team is conducting a randomised controlled pilot trial in children presenting with septic shock. They are assessing the feasibility of a fluid-sparing algorithm using early inotropes and early intravenous administration of Vitamin C, Thiamine and Hydrocortisone and the impact on survival free of organ dysfunction.READ MORE
In a severe trauma, major bleeding or haemorrhaging is associated significant morbidity and mortality. Haemorrhage can be compounded by Trauma Induced Coagulopathy. It is postulated that early replacement of low fibrinogen levels may reduce haemorrhage and improve outcomes. Fibrinogen concentrate is an alternative way to replace fibrinogen.
In the FEISTY pilot trial, we demonstrated that a guided fibrinogen replacement strategy utilising either fibrinogen concentrate or cryoprecipitate is feasible. We found that fibrinogen concentrate was significantly faster to administer. The follow-on FEISTY II Trial will evaluate relevant patient-centred endpoints of a guided dose of FC Vs cryoprecipitate in traumatic haemorrhage. This larger study builds on the success of FEISTY to include multiple trauma centres in Australia and overseas.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 (ARISE FLUIDS). 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).
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
Life threatening bacterial infections such as sepsis are a leading cause of childhood mortality. International authorities recognise the urgent need for better recognition, diagnosis, and management of children with sepsis. Children in regional and remote settings are at particular risk for late or inaccurate diagnosis resulting in worse outcomes.
In this study, we are testing the feasibility, performance, time-to-diagnosis, and cost impact of applying the most advanced genomics-based sepsis diagnostic tools. This could lead to better treatment of infections, reduce unnecessary antibiotic use, shorten hospital length of stay, improve patient outcomes, and allow patients and families to be managed closer to home, with the aim to provide the same care for all children around the state. We are recruiting acutely ill children presenting with suspected sepsis to Emergency Departments, including regional and remote centres in Queensland.READ MORE
Traumatic injuries in children are a leading cause of death and disability in Australia. In high income countries, 40% of child deaths are because of traumatic injuries. Fibrinogen is one of the key clotting factors that need to be replaced in severe traumatic bleeding.
Currently, fibrinogen is replaced using cryoprecipitate; a blood product obtained from healthy volunteer donors. This is a precious resource that is stored frozen in the blood bank; it can take a long time to administer and place significant strain on blood banks. Fibrinogen concentrate (FC) is an alternative product used to assist in blood clotting. It is a product that is derived from blood plasma but stored in powder form and can be reconstituted at the bedside and given quickly. The study will investigate whether it is quicker to administer FC than cryoprecipitate, which may reduce haemorrhage and improve outcomes.
This study will enrol 30 children from three major paediatric trauma centres in Queensland admitted with severe traumatic bleeding. Time to administration of fibrinogen replacement and the effect of fibrinogen levels will be measured.READ MORE
Most children with asthma presenting to an emergency department (ED) are managed with inhaled medications and oral steroids. Infrequently, some children are very unwell, and require assistance with their breathing, or intravenous medication Currently, there is minimal information to guide clinicians on which treatment to choose for severe acute asthma. All have side-effects, and we do not know which is most effective. Studies from the UK and Australasia demonstrate significant variation in practice, although Australasian data is nearly 10 years out of date. When comparing treatments, it is important to determine whether or not they can reduce the risk of severe complications, or whether they make a difference in important treatment outcomes.
This project will allow us to determine current management practices for children with severe acute asthma and/or wheeze; how common severe acute asthma is and also how frequently complications of severe asthma occur; and understand where differences in therapy exist between states/regions. We will be looking at sites across Australia and New Zealand. Once complete, this project will provide important data to allow us to design future research to establish the best treatments for severe asthma.
EMF is funding the Queensland sites taking part in this Australasian trial. This study is being run by the PREDICT network. The Chief Investigatory is A/Prof Simon Craig. The study will include 18,000 children aged 1 – 18 years treated for asthma in the ED.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
Children may present to an emergency department with life threatening conditions that require immediate treatment to support their breathing to allow enough oxygen to be supplied to the body. In these circumstances a child is given medication to put them to sleep and the airway is secured with the insertion of a tube into the windpipe. This transition from spontaneous breathing awake to controlled respiration under anaesthetic via a breathing tube is called intubation and is associated with a high risk for low oxygen levels in the body or low blood pressure.
Newer methods to avoid these risks are currently the subject of many trials. In our study we investigate a new approach to prevent a drop in oxygen levels during intubation using high flow oxygen delivery. We have tested this method in children with healthy lungs undergoing anaesthesia for elective surgery and we found that we can maintain oxygen levels more than twice as long as using standard intubation methods. These findings would allow the operator in emergency settings more time and a safer condition to secure the airway in a sick child.
Therefore, we aim to compare this new oxygenation method with the current standard practice to intubate a child in an emergency situation. We aim to demonstrate that the new method will reduce the risk for low oxygen levels in the blood and also prevents low blood pressure associated with intubation.READ MORE
This clinical trial aims to improve the quality of the resuscitation of patients with traumatic haemorrhage. We are enrolling 100 patients from four major trauma centres in Queensland. Patients admitted with severe traumatic bleeding will be given either Fibrinogen concentrate or cryoprecipitate. Time to administration of these products and effects on blood fibrinogen levels will be measured. We are using innovative technology to identify hypofibrinogenaemia; we will provide data to define the optimal method of replacement and monitoring of the end points of resuscitation; and provide data on the role of fibrinogen concentrate and its use in traumatic haemorrhage. We are also exposing a broad range of ED physicians to potential practice changing research that may be translated to use in other patient groups with critical bleeding.
More than 7000 Australians are treated for severe trauma every year. Major bleeding in the setting of trauma is associated with poor outcomes and increased rates of death. Severe trauma causes a decrease in the factors within the blood that helps clots to form and stop bleeding. This loss of clotting factors is associated with worse outcomes and it is proposed that early replacement of these factors may reduce bleeding and improve outcomes. Fibrinogen is one of the key clotting factors that needs to be replaced in severe traumatic bleeding. Currently fibrinogen is replaced using cryoprecipitate; a blood product obtained from healthy volunteer donors. This is a precious resource that is stored frozen in the blood bank; it can take a long time to administer and place significant strain on blood banks. Fibrinogen concentrate (FC) is an alternative product used to assist in blood clotting. It is stored in powder form, can be reconstituted at the bedside and given quickly. The study will investigate whether it is quicker to administer FC than cryoprecipitate, which will reduce haemorrhage and improve outcomes. With positive impact for both large urban metropolitan areas and remote isolated communities.READ MORE
Doctors frequently need to order blood tests in the Emergency Department when patients come to hospital with a medical or surgical emergency. In all but the most trivial cases, laboratory blood tests are requested as part of the diagnostic workup. Doctors and even the patient are often concerned about missing a diagnosis if enough blood tests are not done. However, medical research worldwide has revealed that test ordering is excessive and often unnecessary.
The growth in test ordering places an enormous financial strain on our health care system, and includes unnecessary investigations or treatment. Thus, reducing the number of unnecessary tests is important for patients to avoid undue discomfort and worry, and for the hospital to improve work efficiency and reduce costs.
Health care professionals have, therefore, worked out various ways to ensure tests are ordered only when needed. These have included education of junior medical staff, protocols for ordering tests, audits of tests ordered, and feedback of audits to staff. These methods have been successful in reducing test ordering in the short-term, but sustaining a long-term reduction is more difficult.
Queensland Hospital Emergency Departments have implemented methods to reduce excessive test ordering, but it is not known which method is most effective. The aim of this study is to determine maximum efficacy, by comparing the number of tests ordered in four of the busiest Emergency Departments in the state. Specifically we will compare the average number of blood tests ordered per patient treated in the Emergency Department taking into account their age, severity of their illness, and whether or not they were admitted to hospital.READ MORE