ANZCTR search results

This crossover study will examine the effect of body position (30 versus 60 degrees head of bed elevation) on moisture under the skin (subepidermal moisture), at the sacrum (the lower back) and at the heels, in healthy adults. When pressure is applied to the skin, there is a possibility of blood and lymphatic vessel being compressed resulting in inflammation and oedema (increased moisture). This increased moisture is not visible on the skin’s surface; however, technology is available to measure it. It is understood if the pressure is relieved then the increased moisture resolves quickly and is of little consequence to overall health; however, if pressure is maintained PI has the potential to ensue. PI commonly occur over skin that covers bony areas, like the sacrum or heels. By examining if body position influences oedema development in healthy adults we aim to contribute baseline information to inform future studies of populations at greater risk of PI and operational procedures in using the technology. To assess the amount of subepidermal moisture in the tissue at the sacrum and heel, the Bruin Biometrics Provizio Sub-Epidermal Moisture (SEM) scanner will be used. The Provisio SEM scanner is a non-invasive, hand-held device that is used in healthcare clinical practice in the United States of America. The Provizio scanner detects the capacity of tissue to hold electrical charge, known as capacitance by light contact between the disposable sensor (one per participant) and the skin. Tissue will have a larger capacitance with increased moisture levels, as in the case of oedema. The Provizio SEM scanner calculates the capacitance at specific points of contact and computes the delta reading, being the difference between the highest and lowest measurement at an anatomical location. Research to date is suggesting the Provizio delta reading of greater than 0.6 units at the sacrum or heels indicates an increased risk of PI. There is however a gap in knowledge on whether the position prior to utilising this medical device influences the readings. Because each participant is measured in both body positions, the crossover design allows the research team to compare measurements in different positions while limiting individual confounding factors. To attempt to remove any influence of the first position on the second the order of position will be randomly allocated and there will be a 60-minute ‘washout’ period between each position where the participant will be off the bed and be able to walk around. The study will take place over a two-hour period at Griffith University’s School of Nursing and Midwifery clinical laboratories on the Gold Coast.

Fasting is standard of care prior to catheter laboratory procedures. The purpose of this is to reduce the risk of aspiration events during procedural sedation. Generally, this involves 6 hours of solid food fasting with 2 hours of clear fluid fasting. Currently there are limited prospective data reviewing the utility of fasting versus no fasting prior to catheterisation procedures. Recently the CHOW NOW study based in America performed a randomised control trial assessing this question. They demonstrated non-inferiority of no-fasting with a pre-specified margin of 5.9%. We wish to assess the non-inferiority of no fasting for catheterisation laboratory procedures in a multicentre trial with a narrower non-inferiority margin of 3%. Fasting prior to procedures may be associated with patient discomfort and distress. In addition, there are some populations where oral intake is important to prevent adverse events. Examples include those with chronic kidney disease where dehydration, potentially precipitated by fasting, associates with increased risk of contrast induced nephropathy. Moreover, patients are frequently cancelled due to lack of fasting. Relinquishing prerequisites for fasting prior to procedures may assist in providing expedited patient care and reduce adverse events related to underlying disease. The main risk associated with no fasting is that of aspiration pneumonia. In the CHOW NOW study, only 0.7% of the non-fasting group experienced this adverse event. This is an uncommon and treatable complication. Risks of fasting (dehydration, hypotension, hypoglycaemia, contrast induced nephropathy, patient discomfort) may outweigh the benefits in preventing the uncommon event of aspiration pneumonia. Though a randomised trial has already been performed, the American Society of Anaesthesiologists has requested more data prior to the acceptance of no fasting before simple catheterisation laboratory procedures.

The aim of the proposed study is to examine the efficacy of cold-water showers as a potential therapeutic intervention for the reduction of symptoms associated with depression amongst a non-clinical sample. The proposed study will address the question; “Can a cold-water shower intervention, decrease symptoms associated with depression and help to boost well-being”? It is hypothesized that a cold-water shower intervention will reduce symptoms associated with depression. It is additionally hypothesized that a cold-water shower intervention will increase levels of well-being.

Purpose of study: In Australia, up to 1 in 20 women will have a pregnancy impacted by pre-eclampsia, however recent changes to the definition of high blood pressure may assist in finding women most at risk earlier in their pregnancy. This study will explore a new approach to diagnosing pre-eclampsia that could benefit women in the future. Similarly, a third of women are affected by cardio-metabolic conditions during pregnancy such as gestational diabetes (GDM), pregnancy induced hypertension, pre-eclampsia, fetal growth restriction and spontaneous preterm birth. These conditions not only cause significant morbidity during pregnancy but are also associated with increased risk of maternal Type 2 Diabetes and Cardiovascular Disease (CVD) after pregnancy. However, CVD risk prediction tools do not capture these pregnancy-related cardio-metabolic conditions. Younger women and their health professionals have a limited understanding of the risks and screening and prevention are generally lacking. We know that these risks can be reduced by preventative screening (such as early screening for diabetes, abnormal lipid levels or elevated blood pressure) and optimising lifestyle strategies. This study offers an important opportunity to identify and target these women at risk for early intervention and screening. Hypothesis: Biological markers of endothelial, placental, inflammatory and cardiac dysfunction can be used to create an algorithm that can better predict the risk of developing pre-eclampsia, as well as risk of long-term cardiovascular sequelae in patients affected by pregnancy complications. Evidenced by derangement in cardio-metabolic markers following development of these conditions which persists post-delivery. Study design: Prospective observational trial involving two blood collection during pregnancy as well as after delivery. Where possible these blood test would be performed at time of routine pathology collection. Blood test result of patient who develops complication and those who does not is compared to develop an algorithm for prediction and diagnosis of pregnancy complications, as well as evaluate risk of long term cardiovascular complications. This study is observational only and does not interfere with routine antenatal care.

This study is a First in Human, randomized, double-blind, placebo-controlled study of subcutaneous EQ102 administered as single (SAD) or multiple (MAD) doses. In Part A (SAD), up to approximately 48 healthy adult men and women will be enrolled and randomized to 6 cohorts (n=8 per cohort) to receive single ascending doses of EQ102 at doses of 50, 100, 200, 500, and up to 1000 mg or placebo. Dosing in each cohort for Part A will commence with two sentinel participants with one of the two sentinels randomized to receive EQ102 and the other randomized to receive placebo. EQ102 will be given in sequential, escalating doses contingent on a review of safety, tolerability, and available PK data of the previous dose level by a Safety Review Committee (SRC). In Part B (MAD), healthy adult volunteers will be enrolled and randomized to 3 cohorts (n=8 per cohort) to receive multiple ascending doses of EQ102 or placebo. In Part B, up to three dose levels will be evaluated in healthy volunteers. The starting dose for Part B will be based on review of safety and PK data from Part A. The decision to escalate between dose levels will be based upon review of all safety and PK data.

Early childhood is a joyful but often stressful time for parents--mealtimes can be battlefields, leaving the house can be an ordeal, and reasonable requests can result in meltdowns. Parents who regularly feel stressed are more likely to experience poor mental health, including feelings of failure and isolation. In turn, children raised in a stressful environment can have poorer emotional and behavioural development outcomes. Our research aims to investigate a distinctive style of early parenting known as the Respectful Approach and how it may improve stress and other health outcomes in parents and their young children. Originally designed for institutional care in Eastern Europe and introduced to the USA by Madga Gerber, it focuses on developing a cooperative relationship with the child. Parents are guided to treat their infants as capable and independent, with emphasis on sensitive observation and attention to cues. Our preliminary research on the Respectful Approach showed that our parent-child education workshops significantly lowered parents stress levels and increased their parenting confidence. Parents also better understood their children’s capabilities. Going forward, we want to discover whether the Respectful Approach also has benefits for children’s health - particularly stress, behaviour, growth, and development. We want to provide a preventative, evidence-based education program to empower parents to develop cooperative relationships with their young children. We hypothesise this will reduce stress in families and improve child health outcomes.

Iron deficiency is the commonest nutritional deficiency globally, affecting 2 billion people and is the leading cause of anaemia. Iron deficiency anaemia makes people tired and unwell as well as impacting physical function, it is a WHO top 10 leading cause for disability. Anaemia is common in patients undergoing major surgery and associated with worse patient outcomes and increased post operative mortality. The aim of this trial is to explore the mechanisms of iron deficiency over the perioperative time period in patients undergoing cardiac, abdominal and vascular surgery and the response to intravenous iron therapy that bypasses the normal Hepcidin mediated iron pathways. Secondary aims include to assess the efficacy of intravenous iron and measuring potential effects on patients’ physical recovery. AMBLE will be a prospective, parallel-group, double blinded, randomised, multi-centre trial designed to investigate the effects of intravenous iron therapy on disease progression in cardiac, abdominal, and vascular surgery patients. Two separate groups of patients will be assessed: The Perioperative group of patients included if about to undergo major cardiac, abdominal and vascular surgery to assess the mechanisms of iron deficiency in the perioperative period. The Recovery group of patients included 4 weeks after hospital discharge following major cardiac, abdominal and vascular surgery to assess recovery of physical function and anaemia. The outcomes of this research will generate a better understanding of the mechanism of iron deficiency anaemia in surgical patients as well as how this affects post operative recovery. By better understanding the aetiology of iron metabolism in surgery we can determine what intervention (iron +/- EPO) may improve patient outcomes and the administration timing thereof. As a result, more informed decisions will be made regarding iron supplementation and therapy in these patients.

Previous studies have shown that nutritional supplementation with potassium bicarbonate causes older adults to excrete less nitrogen (protein) in their urine. As a major source of protein in our body is muscle, these previous studies suggest that supplementation with potassium bicarbonate may have a muscle-preserving effect. This study will test whether potassium bicarbonate supplementation improves muscle protein synthesis rates in older women. In addition, we will examine whether potassium bicarbonate has beneficial impacts on markers on bone turnover, as there is also some evidence that potassium bicarbonate supplementation may favourably affect bone health in ageing. To do this we will recruit 20 women aged between 65 and 90 years who will take part in two 21-day study phases. During Phase 1, the participants will be randomly allocated to receive either potassium bicarbonate supplements or placebo supplements. After Phase 1, participants will have a 3-week “wash-out” period during which they do not take any supplements. Following this, participants will complete Phase 2. This study phase will be identical to Phase 1 with the exception that participants will take the alternate study supplement. At the end of each study phase, we will measure the rate of muscle protein synthesis. To do this, participants will consume a dose of deuterated water and trained personnel will collect thigh muscle samples and blood samples from each participant. Participants will also collect 24-h urine samples at the beginning and end of each phase. In the blood and urine samples, we will measure markers of bone health and acid-base status.

In 2021, Karitane and the Australian Association of Parenting & Child Health (AAPCH) received funding to deliver a new national perinatal and infant mental health (PIMH) program, called ForWhen. The ForWhen program will provide a national comprehensive stepped continuum of care for parents experiencing moderate to severe PIMH concerns, supporting these families to navigate the complex and fragmented PIMH service landscape. ForWhen Navigators will be based in every state and territory at an AAPCH partner site. From 2021-2024, researchers from the Discipline of Psychiatry & Mental Health at UNSW will conduct a formal evaluation of the ForWhen program. This will include a detailed description of service delivery, and an evaluation of clinical outcomes and implementation effectiveness. Specifically, the evaluation will examine whether clients who access the ForWhen program experience improvements in their mental health and wellbeing, are satisfied with the service, and are successfully connected with appropriate mental health treatment.

Every year more than 22,000 Australians break their hip, costing hospitals $579 million and requiring more than 579,000 hospital bed days. Only 24% of patients regain their usual walking capacity after 4 months. Previous research showed patients receiving higher intensity physiotherapy regained their physical capacity more quickly and spent fewer days in hospital than those receiving regular physiotherapy care. In this trial we will test whether the intervention can deliver the same benefits at a range of Australian hospitals. This randomised controlled trial will take place across 8 acute hospitals, recruiting 620 participants. Participants allocated to the intervention group will receive intensive physiotherapy, delivered 3 times/day for 7 days following surgery. Those allocated to usual care will receive what is usually provided at that site. The primary aim is total hospital length of stay. Secondary aims include costing and patient reported outcome measures over 12 months post hip fracture surgery.