ANZCTR search results

Lifestyle risk factors such as lack of regular exercise, poor diet, ageing, excess body weight, high blood fats and high blood sugar levels can lead to overall inflammation, narrowing and hardening of arteries, thus reducing the ability of blood vessels to dilate effectively. A consequence of ineffective dilation of blood vessels is poor blood flow in the brain and this can lead to memory problems, poor concentration or mood. Certain ingredients from food sources such as the long-chain Omega-3 polyunsaturated fatty acids in fish and fish oil are known to benefit heart health by increasing the elasticity of blood vessels, as well as boosting mood and mental performance. Recently, curcumin from the spice turmeric which gives curry its yellow colour is gaining attention for its anti-inflammatory activities. We believe that curcumin can reduce inflammation and in turn enhance blood vessel function. However, their direct effects on the blood vessels in the brain and resultant impact on mental performance are unknown. In this study, we are looking to determine whether supplementing the diet with fish oil or curcumin or a combination of the two nutrients for 16 weeks can enhance the ability of blood vessels in the brain to dilate. We will also explore its effects on blood pressure, blood fats, glucose and markers of inflammation, stiffness of blood vessels, pain, quality of life, mood and mental performance. WHAT ARE THE AIMS OF THIS STUDY? We aim to determine if 16 weeks of fish oil and/or curcumin supplementation can: A. enhance blood flow in the brain in response to demands and thereby improve mood and mental abilities such as short-term memory, attention and concentration B. enhance perception of quality of life. C. reduce perception of pain and stress D. reduce inflammation, blood sugar levels and blood fats. We are seeking a total of 160 overweight or obese men and post-menopausal women who have not had their period for at least 12 months, age 50 – 80 years old and who are relatively inactive (for example less than 150 minutes of exercise on average per week).

Despite the health benefits of regular participation in physical activity, the vast majority of Australian children are insufficiently active. Schools are ideally placed to promote physical activity to children; however, recent reports suggest many Australian schools do not provide children with sufficient in-school activity or ensure they have the skills and motivation to be active beyond the school setting. Additionally, there is a need for interventions that can be effectively disseminated. The aim of this project is to modify, scale-up and evaluate the effectiveness of an intervention previously shown to be efficacious in improving children’s physical activity, fundamental movement skills and cardiorespiratory fitness. The ‘Internet-based Professional Learning to help teachers support Activity in Youth’ (iPLAY) study, will focus largely on online delivery to enhance translational capacity. This project will provide the evidence and framework for government to guide physical activity promotion throughout NSW primary schools and a potential model for adoption in other states and countries.

The use of ultrasound for vascular access and regional anaesthetic techniques has become an essential tool for day-to-day anaesthesia & critical care. Ultrasound guidance helps avoid complications such as damage to surrounding important structures. It may also increase the success rate of vascular access especially in patient populations with difficult peripheral vascular access (eg. obesity, IV drug use) . Although the ‘out-of-plane’ or short axis approach has been demonstrated to be the easier technique for novice users to learn initially and require less insertion time with potentially higher success rates when compared to the “in-plane” approach, both techniques require a reasonable degree of hand-eye coordination and technical training in this skill is not straightforward. The development of an ‘in-plane’ needle guide mounted to the ultrasound probe has allowed users to ensure the needle is kept within the narrow ultrasound beam to allow better visualization of the needle. These devices have been demonstrated to significantly reduce attempt number and time for procedure when compared with free hand technique for use in ultrasound-guided central venous access. They have also been shown to reduce procedural time and improve needle visibility in an in-vitro porcine phantom study on novice users. A recent study conducted at our centre demonstrated that use of the needle guide improved needle visualization, time to successful procedure and better user satisfaction scores. CIVCO has developed a similar purpose ‘out-of-plane’ Accusite needle guidance system that consists of a reusable bracket and customizable depth needle guides (0.5-3.5cm in 0.5cm increments). We propose that this system will have a great application for peripheral and central vascular access (including PICC lines), and also catheter insertion for regional anaesthesia infusion, because these procedures commonly require out-of-plane approach when performed with ultrasound guidance. Other forms of ultrasound needle guidance systems such as passive electromagnetic and GPS tracking have been investigated showing variable significance in improving ‘out-of-plane’ ultrasound-guided procedure success. To our knowledge, there are no clinical trials comparing a simple, physical, mountable ‘out-of-plane’ needle guide device with free hand technique. Before we perform a clinical trial, we would like to carry out a pilot study to determine the usefulness of this “out-of-plane” needle guide when used in our department by anaesthetic residents, registrars and consultants with different levels of clinical experience on ultrasound-guided out-of-plane procedure. Hypothesis: The use of an “out-of-plane” needle guide decreases time to successful attempt compared with a “free-hand” technique on a phantom psyllium hydrophilic mucilloid fiber and gelatin model.

Patients with type one diabetes typically carbohydrate count and use an insulin to carbohydrate ratio (ICR) to dose their insulin. This ratio assumes a linear relationship between carbohydrate quantities to be consumed and the insulin required to maintain blood sugar levels after a meal. Recent research and reports from families with type 1 diabetes raise the question of the validity of this linear model. This study aims to define the relationship between carbohydrate quantity and the dose of subcutaneous insulin. More specifically, to demonstrate that the current linear ICR approach is too steep resulting in increased events of low blood sugar levels as the carbohydrate content increases. This research project will analyse the response of blood glucose levels after a predominantly carbohydrate based meal. Forty participants between 12 -30 years of age, with type one diabetes on intensive insulin therapy will be recruited. Participants will be fitted with a continuous glucose monitoring system (CGMS). Insulin dose will be calculated using the standard linear ICR using study liquid-meals of 20, 50, 100 and 150g of carbohydrate controlled with similar proportions of fats and protein on four consecutive days (one per day). CGMS data will be analysed to determine whether the relationship between carbohydrate intake and insulin requirements is indeed linear. It is hoped this study will provide important information in the management of type 1 diabetes in both adults and children. Results will assist in building on planned future studies of trialing a non-linear ICR if the hypothesis is supported. This research will be used in our day to day management of patients and guide the development of clinical guidelines to help minimise the occurrence of hypoglycaemia and blood glucose fluctuations after eating.

The purpose of this study is to investigate whether Metamucil and a probiotic (good bowel bacteria) is more effective than Movicol at emptying the bowel while receiving daily radiation therapy to the prostate. Who is this for? You may be eligible for this study if you are aged 50 years or more and have been scheduled to undergo external bean radiotherapy (EBRT) to the intact prostate at the Central West Cancer Care Centre at the Orange Health Service. Study details: Participants will be randomly assigned (by chance) into one of two groups. One group will be prescribed Movicol half strength and a low gas diet (current practice at the treatment facility). The second group will be prescribed Metamucil, Nutralife Probiotic (to promote good bowel bacteria and reduce bowel gas) and a low gas diet. Standard EBRT treatment for prostate cancer is delivered daily (Monday- Friday) over a 7 week period. Laxatives and probiotic use will commence 1 week prior to attending for the radiation planning appointment, then ceased and recommence one week prior to commencing radiation treatment. You will be required to take the laxatives and probiotic daily during the treatment period. In taking part in this study you will also be required to complete of a food and bowel habits diary and attend weekly review appointment with the Dietitian in addition to your usual review appointments with the Doctor or Nurse. It is hoped that results from this study will identify the most effective way to ensure an empty bowel while receiving treatment.

Nearly 50% of patients with systolic heart failure suffer sudden cardiac death (SCD). In patients with ischaemic cardiomyopathy (ICM) and an LV ejection fraction (LVEF) of <30%, primary prevention ICD implantation reduced mortality at 20 months follow-up compared to medical therapy alone. Trials in NICM patients suggested similar findings but failed to reach statistical significance - statistical significance was only achieved when both ICM and NICM groups were combined. urrent clinically based guidelines focus on the importance of symptoms (NYHA Class) and LVEF in determining suitability for ICD implantation. Nonetheless, ICD implantation, despite its mortality benefit in selected patient populations, infers significant morbidity in terms or device related complications including tamponade, infections, inappropriate device therapy (which itself has been linked to increased mortality). Consequently, uptake of prophylactic ICD therapy in Australia has been variable with many major centres failing to comply with international guidelines. Hence, many authors have called for the urgent re-evaluation of current guidelines. Clearly there is a need for further risk stratification to assess the vulnerability of the heart failure population to sudden cardiac death, and other long term morbidities associated with the condition. Myocardial fibrosis is a fundamental event in the development of cardiac failure, and is a common feature in all patients with advanced cardiac failure regardless of the aetiology of cardiomyopathy. Myocardial fibrosis in animal models is associated with worsening ventricular systolic function, abnormal cardiac remodelling and may predispose to ventricular arrhythmia. Also, increasing myocardial fibrosis results in progressive deterioration of myocardial function, with more extensive myocardial fibrosis identified histologically in the hearts of patients with advanced heart failure. Cardiac fibrosis has been identified as a key component of remodelling associated particularly idiopathic cardiomyopathy and our group has demonstrated a clear association with arrhythmogenesis (including VT and VF) in patients with systolic heart failure. For example, recently, our group published compelling data supporting the role of contrast-enhanced cardiac magnetic resonance imaging (CMR) in identifying low risk patients who meet current criteria for ICD implantation yet are unlikely to benefit this intervention. We feel that the cardiac MRI evaluation, particularly its ability to detect both regional and diffuse fibrosis, may be a useful tool in predicting the outcomes of patients with heart failure. This trail seeks to establish a long term prospective data registry to evaluate predictive value of CMR in determining the long term outcome of patients with advanced cardiomyopathy.

Background: Knee osteoarthritis (OA) is a significant and increasing cause of pain and disability in the Australian population. So far, interventions aimed at structural modification have been disappointing. OA affects the whole joint, and inflammation of the joint lining (synovitis and joint fluid) is now recognised as a key part of OA. Animal studies suggest that krill oil is anti–inflammatory. Pilot data in humans shows that krill oil reduces knee pain and systemic inflammation after 30 days, suggesting that an approach targeted at specific mechanisms of disease may be effective for OA. However, this study was of short duration, did not collect any data on structural factors, and included patients with a variety of disorders. Longer, larger follow up studies are required. Aim: To compare, using a randomised, placebo–controlled double–blind design over six months, the efficacy of krill oil vs identical placebo to treat knee osteoarthritis (OA) (both pain and structure) in 260 patients with clinical knee OA, significant knee pain and effusion on imaging. Primary hypothesis: 1) Krill oil decreases pain (assessed by 100mm VAS) by 10mm more than identical placebo over 24 weeks in patients with clinical knee OA, significant knee pain and effusions. 2) Krill oil decreases effusion size by 20% over 24 weeks in patients with symptomatic OA of the knee and knee effusion. Significance and Innovation: If krill oil can both improve symptoms and decrease effusion in OA it has the potential to slow progression to joint replacement. The proposed study represents an innovative approach to this and lends itself to easy implementation as krill oil is already available over–the–counter in Australian pharmacies.

The primary aim of the present project is to determine whether introducing cough reflex testing, when embedded into an established clinical pathway, will reduce the incidence of aspiration pneumonia and subsequent length of stay for acute stroke patients in comparison to patients who did not receive the testing. The secondary aims are to evaluate to the clinical feasibility of implementing cough reflex testing as part of standard initial swallowing assessment for all new stroke patients, the patient’s tolerance and clinician satisfaction. It is hypothesised that individuals who receive the testing will demonstrate reduced rates of aspiration pneumonia and decreased average lengths of stay in comparison to patients who did not receive the testing. This hypothesis is based on the assumption that those at a high risk of silent aspiration, will be identified from the cough reflex testing prior to receiving any oral diet or fluids, thus preventing aspiration from occurring. It is also hypothesised that implementation of the cough reflex testing will result in minimal cost to the organisation, high patient tolerance and high clinician satisfaction. Therefore it is anticipated that cough reflex testing will be a clinically feasible and viable tool when implemented as standard practice for all swallowing assessment in stroke patients.

This was a multicentre multisurgeon prospective doubleblinded randomized and controlled trial looking at the effectiveness of single dose intravenous administration of Tranexamic Acid (TXA) in patients undergoing shoulder arthroplasty. The aim of this study was to extend Level I category evidence of the known benefits of TXA to shoulder arthroplasty. The primary objective of this study was to test the hypothesis that systemic use of Tranexamic acid improves operating conditions, decreases blood loss, postoperative pain and complications such as haematoma and need for transfusion. The secondary objective was to carry out subgroup analysis between reverse and anatomical shoulder arthroplasty with the hypothesis that reverse causes more blood loss than anatomic. All consecutive patients presenting to an elective orthopaedic consultation with a failed nonoperative management of shoulder arthritis indicated for shoulder arthroplasty were considered eligible for this study. After having been screened for inclusion and exclusion criteria, read the information sheet and signed the consent form, patients were blindly randomized to one of 2 groups: Systemic TXA or Control. Patients’ general demographic characteristics such as age, sex, dominance, diagnosis, BMI, American Society of Anaesthesia (ASA) score and other relevant comorbidities were collected in a deidentified database locked on a password-protected computer. During the surgery, patients were administered either 2mg of intravenous TXA or a placebo equivalent (saline solution). Analysed outcome variables included: surgeon’s rating of surgical field visibility and overall appreciation of the complexity of the procedure, operative time, pre- and postoperative haemoglobin and haematocrit levels, drain output at 6,12 and 24 hours, need for transfusion, occurrence of postoperative haematoma, postoperative pain Visual Analog Scale (pVAS), time spent in recovery room and hospital room.

In Australia, 1800 new cases of dementia are diagnosed each week (Alzheimer's Australia, 2015). Despite the alarming prevalence of dementia no medications are available that reverse, or even slow the effects of the disease on the brain. This bleak outlook is only brightened by the likelihood that some dementia is preventable. Modifiable risk factors—including lifestyle practices such as smoking, exercise and a healthy diet—have recently been proposed to be responsible for 66% of all Alzheimer's, which is the most common form of dementia (Xu, Wei et al, 2015). In 2014, a large group of dementia experts asserted that if the population were to adopt a healthy lifestyle, 20% of dementia would be prevented (Yaffe, Kristine et al. 2014). Specifically, regular exercise and diets high in plant foods have been shown to reduce the risk of cognitive impairment (Ahlskog et al, 2011; Lourida et al. 2013). The proposed full trial seeks to be the first to examine in a controlled fashion whether Intensive Therapeutic Lifestyle Change (ITLC), specifically in the form of a lifestyle intervention known as the Complete Health Improvement Program (CHIP), can affect the progression of Cognitive Decline in people with newly diagnosed dementia or mild cognitive impairment. The study will be conducted over a four-year period and will involve people with newly diagnosed dementia, or MCI, self-selecting to participate in an ITLC group (who will participate in a 2 month intensive CHIP intervention followed by monthly follow-up sessions). Cohort randomisation is proposed, the control group receiving care as usual. The pilot study is to test the feasibility of conducting the larger study and assess issues of implementing ITLC with cognitively impaired individuals. ITLC, because of the “number and difficulty of behaviours required by those delivering and receiving the intervention” is a complex intervention according to the UK Medical Research Council guidance. Therefore this pilot study will specifically test the feasibility of recruitment techniques and the appropriateness and acceptability of the intervention (are numbers of people with cognitive decline and their supporters willing to change their lifestyle?), the feasibility of the logistics and timing of adherence and coaching methods, and retention rates in the 10 months after the intense intervention. The pilot will assess the utility of the ad hoc instruments used to measure adherence and the domains of dementia. Data integrity and handling will be assessed. Finally the quality of the results recorded by the researchers in the intended primary outcome of the full trial, the change in cognitive decline and behaviour, will be assessed by the geriatrician. Because this is a pilot study with no control group and the number of participants is expected to be small, the results will be reported without analysis. Results will not be carried forward into the full study.