ANZCTR search results

The blood thinner warfarin is stopped prior to elective surgery for safety reasons. Immediately after the operation it is re-commenced at the usual dose, but takes a week or longer to become therapeutic again (until the blood is thinned out again). This means the patient has to be followed at home by extended care services and injected with a faster acting blood thinner until the warfarin becomes therapeutic again. Some modelling using existing data indicates that if we know the usual warfarin dose of the patient, we may be able to develop a more rapid-acting loading dose strategy that shortens the time for the warfarin to become therapeutic again. This would mean the hospital services wouldn't need to follow the patient for as long, and the patient wouldn't need as many blood thinner injections before their warfarin was therapeutic again.

The purpose of the whole research program is to evaluate the feasibility of replacing several high cost materials currently in use for burn management at the RAH (Integra, Matriderm, Biobrane/cadaver allograft for burn wound temporisation after excision) with a cost-effective, synthetic alternative. This new material has demonstrated superior efficacy in large animal studies and two pilot human trials in non-burn wounds are currently ongoing. This will represent the first stage of a proposed two-stage strategy to abolish the need for split skin grafts in burn care. The second stage is already at an advanced stage of development in-vitro and has similarly proven effective in porcine wounds.

1.Background: Dehydration, or the loss of fluid and salt from the body can sometimes be a life-threatening disorder. Intense exercise can cause the loss of 1-3L of fluid/h and may be aggravated by warm climates (Ramakrishna, 2004). The fluid deficit typically ranges from 2-4% of body weight and can result in thermal stress, impaired cognition and cardiovascular function, accelerated fatigue and impaired exercise function (Rodriguez et al., 2009). During an Australian Rules football game or intensive training session AFL players lose between 1.15-3.45% of their body weight. As outlined above this degree of fluid loss will result in physiological changes that impact on player performance. The current sports drinks consumed by players during and after the game have a high glucose content much higher than in proven rehydration solutions. Because of the high glucose content (hyperosmolar to body fluids) it is inefficient for hydration, leads to a slower than achievable water absorption and only utilises the absorptive capacity of the small intestine and not the large intestine. It has been shown that hypo-osmolar solutions achieve faster and more effective rehydration in children and adults with acute diarrhoea and as a consequence, hypo-osmolar solutions are the WHO/UNICEF policy for rehydration [WHO/UNICEF, 2009] Oral rehydration solutions which utilise the absorptive capacity of both the large and small intestine have been developed and proven effective in the treatment of cholera. Water and salt absorption through the large intestine requires the presence of short chain fatty acids (SCFAs) which are fermented by colonic bacteria from carbohydrates This study aims to build on this foundation work and test a formulation that is designed for healthy guts taking advantage of absorption of fluids and salts from the large and small intestine. 2.Rationale: The current sports (“hydration”) drinks are really energy drinks because they have a high glucose content are designed less for rehydration than they are for delivering glucose. As such they seem to be less than ideal for rehydration when dehydration is evident Provision of “resistant starch” will do this while at the same time providing glucose in the small intestine. It is thus conceived as a dual-action solution providing glucose to stimulate small intestinal uptake and RS for fermentation to SCFA to drive large intestine uptake. This principle has been tested now in four randomised controlled trials in India in severe acute diarrhoea and in all studies it reduces severity of diarrhoea significantly. This study will test whether the use of RS and an oral rehydration solution (Sports-FS-ORS or SpORS), which contains a balance of salts, glucose, and starches which optimise water absorption by also utilising the absorptive capacity of the large intestine, can improve hydration in elite athletes during and after strenuous exercise.

This study is hoping to determine if overnight monitoring in the form of a sleep study can improve the way we set up non-invasive ventilation (a form of assisted breathing that uses a nose or face mask connected to a ventilator)

The project is a case series looking at the effectiveness of a series of self help modules for the treatment of health anxiety. The self-help modules are based on evidence-supported intervention and were developed by expert clinical psychologists. The project will entail the recruitment of four participants whose primary condition is health anxiety and their assessment. The selected participants who meet the selection criteria and consent to the participation will be emailed these modules weekly. The project aims to investigate if pure self-help is an effective treatment for health anxiety by assessing if the participants demonstrate reliable and clinically significant change. If so, this will improve treatment accessibility and affordability for individuals who suffer from this problem.

Background: Regular exercise is fundamental for older adults with heart disease. However, most find it difficult to meet the National Physical Activity Guidelines of 150 minutes per week moderate intensity exercise (for example, walking). Music is easy to use and may motivate older adults with heart disease to complete more physical activity. Aim: To find out if listening to music while walking helps older adults with heart disease to achieve recommended amounts of physical activity. Design: A randomised controlled trial, comparing one group of participants walking with self-selected music, and another group walking without music. Measures will be collected at discharge from cardiac rehabilitation (baseline), and at weeks 6 and 26 following discharge. Participants: We will recruit 53 participants and randomly allocate then to either walking with or without music. Participants will be eligible if they are 60 years and older, have been diagnosed with heart disease, and walk independently. Measures: Amounts of physical activity will be measured over 7-days using an accelerometer, a small device attached to each participant's thigh. We will also test walking endurance, blood pressure, weight, and waist circumference. Participants will be asked to answer a questionnaire about exercise and complete an exercise log-book. Intervention: All participants in the music group will receive a personal music playing device with their preferred music to use during walking. Participants in the group without music will receive usual care. Data analysis: Comparisons between the two groups will aim to see if there are more participants in the music group who meet the National Physical Activity Guidelines than in the group without music.

Shock is a medical emergency in which the organs and tissues of the body are not receiving adequate blood flow. Preventing low blood pressure (or hypotension) in such patients is an integral part of standard treatment, but it is unclear what degree of hypotension in relation to patients’ usual resting/basal blood pressure (basal-BP) should be treated. In our pilot study, we reported that in usual practice, the achieved-BP for shocked patients in intensive care unit (ICU) was generally lower and often unrelated to their basal-BP. It resulted in varying degree of untreated relative hypotension (BP-deficit) that was associated with an increased risk of acute kidney injury (AKI). The main purpose of this study is to test or confirm these findings in a broader clinical practice. Further, the novel data on both degree and duration of relative hypotension accepted in routine care in a broad multicentre setting would be crucial to design a major interventional trial. Our hypothesis for this study is that some degree of relative hypotension, quantified as mean perfusion pressure deficit (MPP-deficit), would be common in routine care for vasopressor-treated patients. In critically ill patients, who often have blunted autoregulation, a persisting MPP-deficit may fail to restore adequate renal perfusion that may result in worsening kidney function. We hypothesize that such MPP-deficit, a measure of untreated relative hypotension, in patients with shock during vasopressor therapy is associated with an increased risk of new-onset AKI. The association between study exposure variables and outcome measures will be adjusted for pre-specified covariates in a multivariate model.

In this parallel randomised controlled study in individuals with type 1 diabetes, we will compare two methods of adjusting the dose of insulin to match the nutrients in a meal. One method, known as carbohydrate counting, uses an algorithm (= formula) that matches the dose of insulin to the carbohydrate content of the meal. The second method uses a novel algorithm based on the food’s normal insulin response in healthy subjects (the Food Insulin Index or FII). Participants will be randomised to either the carbohydrate counting or FII intervention group and will receive education regarding the practical implementation of their corresponding algorithm. Glycosylated haemoglobin (HbA1c) and postprandial glycaemia and the occurrence of hypoglycaemia (recorded using a Continuous Glucose Monitoring System, CGMS) will be compared at baseline and after 3 months. We hypothesize that using the novel FII to adjust mealtime insulin dose will improve blood glucose control, compared with carbohydrate counting.

Cellulitis and erysipelas are common skin infections, and it is not known what the ideal duration of IV therapy is for treatment. This is a trial which commenced at Barwon Health in November 2012 expanded to multiple sites in Australia and New Zealand to study whether a short-course of IV therapy is not inferior to longer duration IV therapy. Over 300 participants are required for this trial, however a lack of funding led to only 80 being recruited. The trial was ceased in 2016. Patients who attend hospital emergency departments, or are admitted to hospital wards, or hospital in the home (HITH) programs with a diagnosis of cellulitis and are planned for IV therapy are reviewed to determine if they fulfill the criteria for inclusion in the trial. Those who meet the criteria and agree to participate are consented to participation in the trial, and are then randomly allocated to either IV therapy of 72 hours or more (as an inpatient or on hospital in the home) or 24 hours IV therapy, both followed by oral therapy for a maximum of 7-10 days. Antibiotics that are used are those ordinarily recommended for cellulitis and are not experimental. Each participant is involved for approximately one month, including 3 visits over the first 10 days and a follow-up phone contact at Day 30. In order to determine that short course IV therapy is safe and effective when compared to longer durations, we measure the following things to determine that cellulitis has resolved: 1) That fever has resolved at 48-72 hours 2) That skin abnormalities have not gotten worse at Days 7-10 3) That ongoing antibiotic therapy is not required after 10 days. We also measure; time taken for fever to resolve, pain as reported by the patient, photos of the affected leg over the first 10 days, and whether there are any side effects that patients experience while on this trial. At 30 days the patient is telephoned to check that their cellulitis has not recurred.

The study aim is to determine whether the availability of a simple blood test for colorectal cancer will improve participation in screening for colorectal cancer (CRC). Our hypothesis is that a blood test will improve participation in screening for CRC. Patients attending General Practices in Adelaide that are involved in the study, who are aged 50-74 years old and are at average risk for bowel cancer may be invited to participate in this study. Study details: Many people do not participate in stool (faecal) sample-based screening programs for early detection of colorectal cancer because of their dislike for the test. The purpose of this research is to determine if a blood test for colorectal cancer, if offered to people who have just declined a standard faecal occult blood (FOB)-based screening test, will be completed and result in a significant improvement in the overall program participation rate, relative to a program where only faecal occult blood test (FOBT) is offered. Participants in this study will be randomly (by chance) allocated to one of two programs – one where they are offered the blood test if they declined the FOBT provided through the study, and one where FOBT is offered twice. We will assess how many of these invitees completed a screening test and compere participation rates between groups.