We propose to conduct a multi-centre blinded cluster cross over randomised clinical trial (RCT) of plasmalyte (PL), a balanced salt solution versus normal saline (NS) in patients admitted to an Intensive Care Unit (ICU) with diabetic ketoacidosis (DKA), a life-threatening complication of diabetes mellitus. DKA results in elevated acid levels in the blood leading to severe dehydration and electrolyte imbalance.
ICU admission rates for patients with DKA in Australia has risen annually. In 2019 and 2020, there were 2751 and 2812 admissions to ICUs respectively. Almost all patients present through the Emergency Departments and in regional hospitals, they are often admitted to the ICU.
NS is often used as the first line fluid for dehydration, but NS use frequently results in persistent acidosis. We have shown in a pilot trial, conducted in 7 Queensland regional Emergency departments and ICUs, that the use of a balanced salt solution such as PL resulted in a more rapid resolution of acidosis with trends to shorter length of ICU and hospital stay as compared to NS. The efficacy of PL in DKA needs evaluation in a large clinical trial.
We plan to study 480 patients from Australia of whom a third will be expected to be enrolled in Queensland. Patients will be randomised to receive either NS or PL and the primary end point is hospital length of stay. This proposed trial will answer a fundamental clinical question and will inform policy and practice in Australia and New Zealand and around the world.READ MORE
Abdominal pain is one of the commonest reasons for children to attend the emergency department (ED), and acute appendicitis is the most common cause of abdominal pain requiring surgery. There are various clinical prediction scores that have been developed to help doctors diagnose appendicitis; however, most scores were developed overseas and are not routinely used in Australian EDs. The aim of this project is to review different published scores and compare them with overall clinician impression in diagnosing acute appendicitis in children presenting to ED.
The project will include all patients presenting to the ED with abdominal pain that are having investigations for possible appendicitis. The treating doctor will be asked to complete a case report form detailing patient history, examination findings, investigation results, as well as their overall clinical impression of the patient’s likelihood of having the diagnosis of appendicitis. Data collected will be analysed by project researchers to determine which scores are the most helpful for clinicians in diagnosing acute appendicitis in children presenting to Australian EDs, with the expectation that this will improve future care provided to children with abdominal pain.READ MORE
Acute severe behavioural disturbance (ASBD) is an emergency situation where a patient experiences severe agitation or aggression. These individuals commonly present to the emergency department (ED) for treatment. Medications are often provided to assist the person to feel calmer. In most instances, oral medications are used. When the patient is extremely agitated, an intramuscular (IM) injection will be given.
In individuals less than 18 years, there is minimal available evidence to guide doctors about which medications work best. It is also not known how well these medications are tolerated by these young people. Therefore, the PREDICT (Paediatric Research in Emergency Departments International Collaborative) network is running two trials across a number of Australian EDs to create evidence to be used to guide the treatment for these young people.
The first study (PEAChY-O) compares two oral medications - olanzapine and diazepam - to determine which medication works better. The second study (PEAChY-M) compares two IM medications – olanzapine and droperidol. These medications were chosen because they are used as standard of care in Australian EDs and are recommended on current Clinical Practice Guidelines (CPGs). These are important studies because they will be the first trials to compare any medications head-to-head in a randomised trial across either the oral or IM routes.
Once the results are available, they will be used to guide future clinical practice including influencing the recommendations made in Australian guidelines, ensuring that these young people receive evidence-based treatments.
Chronic liver disease (CLD) is prevalent in Australian society and is the 11th leading cause of premature death (1). Thirty eight percent of patients experience gastrointestinal bleeding (GI) as a complication(2). The underlying balance between bleeding and clotting tendency is altered in chronic liver disease, making management of acute bleeding challenging in the emergency setting(3). There is a lack of high-quality evidence to guide the best combination of blood products and other medications to stop bleeding(4).
Prothrombinex®-VF is a blood product which can help to improve the level of clotting factors in the body thereby reducing bleeding tendency. It is indicated for anticoagulant reversal in acute bleeding(5). In practice many emergency physicians have used the product for patients with chronic liver disease who present with acute bleeding, although it is not licensed for this indication(6).
A retrospective Queensland study performed by this author showed that half of Prothrombinex®-VF usage for liver disease was in the emergency department by emergency physicians. It suggested that the product makes little impact on reversal of laboratory blood clotting tests and it raised important safety concerns regarding the develop of a syndrome of accelerated bleeding and clotting concurrently(6).
This expanded statewide audit of Prothrombinex®-VF in chronic liver disease in Queensland seeks to define efficacy and safety of the product. There is no statewide guideline for Prothrombinex®-VF and this data will contribute valuable information to developing future guidance for clinicians.READ MORE
Currently in Australia, children with suspected neck injuries undergo neck scans such as x-rays, computed tomography (CT) or magnetic resonance imaging (MRI). However these scans may carry risks from radiation exposure, and are often associated with discomfort and distress for young patients and the need for sedation.
Considerable emergency department time and costs are also associated with these scans and it is unclear when it can be safely avoided. Rules and tools can help doctors decide when scans are necessary. The SONIC study aims to look at whether existing rules for adults are also appropriate for use in children, and to develop and test a specific tool to help doctors decide which children need a neck x-ray or scan. The study will involve a large number of children across multiple hospitals in Australia and New Zealand. The research is expected to help researchers learn more about looking after children with neck injuries and hopefully allow us to safely limit the number of scans that need to be done.
The SONIC study is also supported by the Commonwealth of Australia through a MRFF Grant ID1199748 administered by the Murdoch Children’s Research Institute.READ MORE
This is a multicentre, open-labelled diagnostic randomised controlled trial to comparing the use of portable ultrasound and x-ray imaging to diagnose a buckle fracture in children. The trial will determine if there are differences in functional outcomes, patient and care-giver preferences, and health system benefits.
Children frequently present to the emergency department with forearm injuries and often have an x-ray to assess if there is a fracture. Due to the soft and plastic nature of the bones in young children, injuries can cause their bones to bend, known as a buckle fracture. Bedside ultrasound is a test that emergency practitioners can use to rapidly diagnose a fracture at the time of examination, without exposing children to ionising radiation. Ultrasound in this setting is well tolerated, only requiring light touch and gentle manipulation of the forearm and has similar accuracy when compared with x-rays for diagnosing children’s forearm fractures.
This is the first trial of its kind to assess whether an x-ray is unnecessary when there is either a buckle fracture or no fracture seen on a portable ultrasound machine. This is important as they can be treated at the time of review without any further delay, which will avoid these children being exposed to ionising radiation. Children will be randomised to receive either an ultrasound or x-ray for their forearm injury. Both groups will be followed up to see whether there are any differences in their recovery and to determine any complications. We will also determine the time and cost implications of this new approach, which could enable families to go home earlier and could be more cost-effective, with less x-rays being ordered.READ MORE
From a health perspective, a disaster overwhelms the normal operating capacity of a health service, where an outside health response is required to restore and maintain the normal day-to-day health services and standards of care for the disaster-affected community. The Australian healthcare system is tested annually with disasters of a conventional nature (e.g., floods, cyclones, bushfires), however, the Australian healthcare system has not been recently tested by non-conventional disasters such as Chemical, Biological, Radiological, Nuclear, and explosive (CBRNe) disasters. As a result, the ability to determine the healthcare system response is difficult. Further, there is no research specific to the Australian emergency department’s capacity for disaster response in CBRNe events.
This study addresses this gap. We will use a mixed methods approach to undertake two discrete, yet related studies. Study 1 involves undertaking surveys with key emergency disaster personnel from seven Queensland hospitals to describe the capacity of hospital emergency care services ability to respond following a CBRNe disaster. Study 2 includes undertaking focus groups with key clinicians and leaders from the participating sites to identify and explore enablers and barriers within emergency care services to provide CBRNe disaster response. Findings from these studies will provide an evidence base regarding the capacity for several Queensland emergency departments, located in metropolitan, regional and rural settings, to respond to disasters.READ MORE
Sepsis is devastating infection, leading to organ dysfunction. Sepsis kills more children in Australia than road traffic accidents. One out of three survivors will suffer from long-term health problems. Faster recognition of sepsis can save lives. However, recognising sepsis in children can be difficult, as children with sepsis initially present with symptoms similar to common infections. Currently, the recognition of sepsis is based on physician assessment of patients, and laboratory tests. Sadly, a common finding in Coroner`s investigations of sepsis deaths is that parents represented several times to health-care facilities, stating their concerns that “something is wrong” with their child. There is at present great debate as to what role parental concern should have in sepsis recognition.
We hypothesise that parents as experts of their child provide important information to recognise disease severity in their child. We will perform questionnaires with parents, and with medical and nursing staff when a child is evaluated for sepsis. We will compare the value of measuring parental concern in comparison to healthcare worker assessment, clinical signs and symptoms, and routine infection markers.READ MORE
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
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