ANZCTR search results

Derangements of serum phosphate concentrations, specifically hypophosphataemia, are common among ICU patients and our previous work has suggested this may be associated with worse clinical outcomes, including higher mortality and morbidity. Although replacement of phosphate through both intravenous and enteral routes is common in ICUs, the optimum threshold of serum phosphate at which to commence active replacement in critically ill patients is currently unknown, and the benefits have never been confirmed with an RCT. Resultantly, there are no consensus guidelines on phosphate replacement in ICU, with individual ICUs and clinicians self determining thresholds at which to replace phosphate. Such treatment comes at significant cost and there are potential adverse outcomes associated with phosphate replacement including hypocalcaemia (potentially precipitous and life-threatening), nausea, vomiting, diarrhoea and hypotension. Thus, ICU clinicians are left with substantial uncertainty about the optimal threshold at which to replace phosphate. Therefore, a clinical and ethical imperative exists to conduct a high-quality, investigator initiated, RCT to inform clinical practice with regards to phosphate replacement and its impacts on patient centred outcomes in critically ill patients. The PRICE-1 RCT will compare the use of a restrictive phosphate replacement protocol against a liberal phosphate replacement protocol for the management of serum phosphate levels in critically ill patients. The liberal protocol will start replacing phosphate when the serum concentration is below 0.80 mmol/L, whereas the restrictive protocol will start replacement when the serum phosphate concentration is below 0.50 mmol/L. The choice of oral versus intravenous phosphate administration is determined by the functioning of the patient's gastrointestinal tract. All other aspects of patient care will be determined by the treating clinicians as is appropriate for the condition/s with which the patients are admitted to the Intensive Care Unit. We hypothesise that use of a restrictive phosphate replacement protocol, compared to a liberal protocol, will result in reduced amount of phosphate replacement administered to critically ill patients in the Intensive Care Unit. Additionally, we hypothesise that the conduct of an electronic database-integrated cluster randomised trial will be feasible.

Aim/s, hypothesis and /or research question This is primarily a feasibility study to ascertain the achievability of larger scale studies involving the use of activity trackers in joint replacement (and potentially other operations) patients. Primary aim: 1. To investigate the association between PA and SB and postoperative outcomes (pain, function, quality of life, complications) and determine the composition of PA and SB (including the intensity of PA and time spent sitting, standing and sleeping) associated with better postoperative outcomes. Secondary aim: 1. Investigate the association between preoperative PA and SB and preoperative health status (pain, function, quality of life) 2. Characterise and compare PA and SB (including the intensity of PA and time spent sitting, standing, stepping, sleeping, number of sit-to-stand transitions per day, number of bouts of prolonged sitting >30 min) in patients undergoing hip or knee replacement in the preoperative, immediate-postoperative and 3-month postoperative stages Evidence gathered from the proposed study will be used to initiate a program of research to inform the design and implementation of larger multicentre observational and interventional studies with larger numbers of the participants and extended follow up periods. Primary hypothesis: Post-operative outcomes will be associated with PA and SB and will be influenced by the intensity of PA performed and the amount of sedentary time. Those with higher levels of pre-operative activity will be less likely to have post-operative complications, and the inverse relating to sedentary time.

Obesity is a leading contributor to preventable mortality in Australia. While the causes of obesity are multifaceted, epidemiological studies suggest that overconsumption of highly rewarding energy-dense and ultra-processed food is a leading driver of rising obesity rates. Our team has previously shown that obesity is associated with abnormal communication between the brain regions involved in reward responses to food (i.e., the medial prefrontal cortex [mPFC], striatum and insula), and those involved in energy regulation (i.e., the hypothalamus). These regions and their connections have also been linked to food cravings which are a known driver of overconsumption. Therefore, interventions that can modulate neural connectivity between cortico-striatal-hypothalamic regions are promising candidates to reduce food cravings in people with obesity. The connectivity between these brain regions can be modulated using non-invasive brain stimulation, namely a form of repetitive transcranial magnetic stimulation (rTMS) known as continuous theta burst stimulation (cTBS). rTMS is an FDA approved treatment for depression and is being trialled for multiple psychiatric and neurodegenerative diseases. In this trial we will test if rTMS-cTBS can reduce abnormally increased connections between brain regions involved in food reward responses in obesity. We expect that rTMS-cTBS over the mPFC will reduce abnormally increased connectivity (i.e. neural communication) between the mPFC and regions of the brain reward circuit involved in food cravings.

The purpose of this study is to assess the safety and immune system response to treatment with Tislelizumab in patients with Epstein-Barr virus (EBV)–positive diffuse large B-cell lymphoma (DLBCL). Who is it for? You may be eligible to join this study if you are aged 45 years or older and have been diagnosed with EBV-associated DLBCL, without immunosuppression. Study details All patients enrolled in this study will receive treatment based on 21-day cycles, with 4 stages: 1. "Induction" stage, involving intravenous Tislelizumab (200mg) and Rituximab (375mg/m2) on day 1 of each cycle over 3 cycles (9 weeks total). 2. "Combination" stage, involving Tislelizumab (200mg), Rituximab (375mg/m2), Cyclophosphamide (750mg/m2), Doxorubicin (50mg/m2), Vincristine (1.4mg/m2, up to a maximum of 2mg) on day 1 of each cycle; and oral tablet Prednisolone (100mg) daily on days 1 to 5 of each cycle. There are 6 cycles for this stage (18 weeks total). 3. "Cell Therapy" stage, involving intravenous Epstein-Barr Virus (EBV) virus specific T-cells (Auto-EBV-VST). Two infusions of 3x10^7/m2 each will be given a week apart. Six weeks after the 2nd infusion, patients will have a PET/CT scan to assess if the cancer has disappeared. If so, the patient will move to the next stage, "Maintenance". (However, if the cancer has not disappeared, the patient will be withdrawn from the treatment phase of this trial.) 4. "Maintenance" stage, involving intravenous Tislelizumab (400mg) on day 1 of every second cycle over 16 cycles (48 weeks total). Overall, the study will take 83 weeks. Other testing that will be performed includes serology, blood tests, bone marrow assessment and ECHO scans (at baseline and end of treatment). It is hoped that the research will provide evidence for the safety of this immune-based approach, and lead to better outcomes for EBV-associated DLBCL lymphoma patients.

This trial aims to determine the prevalence of vestibular dysfunction in patients admitted to a specialist rehabilitation unit. Who is it for? Patients aged 18 or above, current inpatients of BIRU or GARU wards at Princess Alexandra Hospital, Queensland Study details All participants will complete the Vestibular Screening Test and then complete objective vestibular testing. All participants from the same ward will be tested consecutively on the same day. It is hoped that this study will demonstrate the prevalence of vestibular dysfunction within patients of the specialised wards. It is also hoped that the outcomes of this project may have implications for physiotherapists working in subacute rehabilitation units to include vestibular screening as part of their standardised initial physiotherapy assessment on admission. A timely and routine vestibular screening assessment could be a worthwhile adjunct to the standard physiotherapy assessment to guide early and appropriate intervention and achieve optimal rehab outcomes.

Only 15% of cardiac rehabilitation attendees are achieving the physical activity guidelines. In people with heart disease, insufficient physical activity is an independent risk factor for all-causes of death. Within cardiac rehabilitation, people with heart disease are encouraged to meet the physical activity guidelines. Yet clearly, an innovative and effective physical activity intervention is needed in these programs. Our preliminary work has found that regular physical activity measurement by health professionals alone can drive physical activity adherence in insufficiently active adults. However, the optimum frequency of measurement in cardiac rehabilitation is unknown. ‘Measure It!’ is a very brief intervention, taking clinicians less than 5 minutes to complete. It includes a self-report and objective measure of physical activity (wearable activity tracker steps) plus physical activity advice. We will test two frequencies of physical activity measurement (2 and 5 measurements in total) by cardiac rehabilitation clinicians over 24-weeks. This hybrid effectiveness-implementation trial will recruit 190 insufficiently active cardiac rehabilitation attendees from 5 cardiac rehabilitation programs in the Australian Capital Territory and New South Wales. Daily minutes of accelerometer moderate-to-vigorous physical activity is the primary effectiveness outcome. Implementation outcomes will include acceptability, appropriateness, adoption, costs and sustainability. We hypothesize that 5 physical activity measurements over 24-weeks will result in increased accelerometer daily minutes of moderate-to-vigorous physical activity in insufficiently active cardiac rehabilitation attendees with heart disease compared with 2 physical activity measurements. If ‘Measure It!’ is successful, we will be able to recommend ways to incorporate this very brief intervention into cardiac rehabilitation service delivery. It will be a time and cost-effective approach to targeting physical activity within and beyond cardiac rehabilitation programs. Results will potentially drive changes in current practice, directly informing the development and implementation of cardiac rehabilitation services, leading to improved health for a large number of Australians with heart disease.

Autologous haematopoietic stem cell transplantation (AHSCT) is a procedure that is typically used to give high doses of chemotherapy to patients with blood cancers, followed by stem cell infusion, so that a new blood and immune system can regrow. Stem cells are collected from the blood following stimulation with intravenous cyclophosphamide chemotherapy and granulocyte colony stimulating factor (GCSF) injections. Patients are then admitted into hospital to receive high doses of chemotherapy that intensely suppresses their immune system. Subsequently they have their stem cells transfused to re-grow a new immune system and provide protection from the toxic effects of the chemotherapy. It takes about 14 days for the new stem cells to grow and all patients are monitored carefully over the subsequent months and years to see if the immunosuppression controls their auto-immune disease. Over the last 15 years AHSCT become much safer, and evidence has accumulated suggesting a proportion of patients with severe autoimmune conditions will respond to AHSCT. Often these patients had prolonged remissions of their AID. In well selected patients there is a possibility to establish a prolonged period of disease remission.

Q fever is a highly infectious disease caused by the bacteria Coxiella burnetii. Currently there is an effective Q fever vaccine which is recommended for those considered to be in “occupational at risk” groups, such as abattoir workers, veterinarians and farmers. However, several recent studies have highlighted that the risk in the non-traditional “at risk” groups, such as children, metropolitan dwellers, is higher than previously thought. The only vaccine available in the world is Q-VAX®, which is, according to the Australian Immunisation Handbook, only recommended for people aged 15 years or over, and therefore children under 15 years old, who are at risk of contracting Q fever, because they live on farms, near abattoirs or are children of “at risk” workers cannot be vaccinated. This is a Phase IV, multi-centre, vaccine trial in which 1000 children, aged 10 to <15 years, and 100 adults (aged >=15 to <=30 years) will be recruited across NSW and Queensland. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of the licensed Q fever vaccine (Q-VAX®) in children aged 10 to < 15 years.

The widespread misuse of prescription opioids is a current ‘crisis’ that is already being faced in many countries, including the United States and Canada. Australia is rapidly following the same path as opioids are often prescribed to patients who present to EDs with pain. Australia now ranks eighth internationally on the number of daily doses of prescription opioids per million population (at approximately 40% the level of USA. A proportion of these would result from the prescribing of opioids by physicians in the emergency setting. The principle hypothesis of this study is that restricted prescription of Oxycodone in the Emergency Department will significantly reduce opioid prescription rates compared to current practice including educational programs

A postoperative pulmonary complication (PPC) is more than 15 times more common following upper abdominal surgery (UAS) than a cardiac complication. A PPC more than doubles the baseline cost of abdominal surgery.1,2 A single PPC costs the hospital approximately $AUD 45 000 to treat.1 John Hunter Hospital is a major centre in NSW for UAS such as open gastro-oesophageal cancer resections, performing 384 UAS procedures in 2019. Due to the pathophysiological impact that these higher risk procedures have, PPCs are more likely to occur when compared to lower abdominal and non-thoracic surgeries.2,3 Prospective collection of PPCs in a group of patients undergoing UAS at JHH (n=48) between November 2021 and June 2022 demonstrated a rate of PPCs of 25%. An Australian/New Zealand multicentre randomized control trial (RCT) and economic analysis evaluated the impact of a simple 30-minute preoperative Physiotherapy education intervention for those undergoing high risk abdominal surgery.3 (ACTRN12613000664741) This intervention involved education related to postoperative pulmonary complications, their causes and implications, and the importance of deep breathing, coughing and early mobility in their prevention. This intervention resulted in a reduction in the incidence of PPC by half and an absolute risk reduction of PPC of 15%. 3 It is unclear how this research translates into clinical practice, particularly when preoperative flow may differ between health services and also when many perioperative appointments are now conducted via telehealth. This research aims to evaluate the feasibility of the pragmatic delivery of a 20 minute 1:1 physiotherapy preoperative education session (Boden et al 3) for people undergoing UAS at JHH and the impact on PPCs . We hypothesise, that more than 90% of patients eligible for this study will be delivered the preoperative education, and that a reduction in PPCs, similar to that reported by Boden et al 3, will be observed. 1. Fleisher LA, Linde-Zwirble WT. Incidence, outcome, and attributable resource use associated with pulmonary and cardiac complications after major small and large bowel procedures. Perioper Med (Lond). 2014;3:7. 2. Serpa Neto A, Hemmes SN, Barbas CS, et al. Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis. Lancet Respir Med. 2014;2(12):1007-1015. 3. Boden I, El-Ansary D, Zalucki N, et al. Physiotherapy education and training prior to upper abdominal surgery is memorable and has high treatment fidelity: a nested mixed-methods randomised-controlled study. Physiotherapy. 2018;104(2):194-