ANZCTR search results

Chronic kidney disease (CKD) affects approximately 10-15% of the population in developed countries. Cardiovascular disease (CVD) is the greatest risk faced by CKD patients compared to the general population, with an increased mortality that parallels the decline in renal function. Traditional strategies to reduce the risk of CVD, such as lipid lowering and blood pressure control, have had limited impact in the CKD population. This is likely because much of the excess risk of CVD has been attributed to non-traditional risk factors such as anaemia, inflammation and accelerated vascular calcification (VC) and arterial stiffness, related to abnormal phosphate and calcium metabolism in this population. Vitamin D deficiency has been linked to vascular calcification in epidemiological studies. Our aim is to assess as to whether vitamin D supplementation can delay or decrease the progression and incidence of vascular calcification in this population. At this stage there have been no clinical trials assessing the impact of vitamin D therapy on improving CV outcomes or altering the natural progression of surrogate CV markers such as VC and arterial stiffness in the CKD population.

We are conducting a trial to systematically evaluate if 14-24 year old young people are more likely to complete a telephone interview if they receive a guaranteed movie ticket upon completion compared with a 1/500 chance of winning a bigger prize ie an iPod. This trial is nested within a larger randomised controlled trial (RCT) ("Health risk screening and counselling of adolescents and youth friendly practice: a cluster randomised controlled trial in primary care" - ISRCTN16059206) which is exploring the effects of a systems level intervention encouraging youth friendly practice in primary care.

The life expectancy gap for Indigenous people in Australia is 13 years and most of this gap is due to preventable chronic disease (diabetes, heart, lung and renal problems) in adults. Once people have these conditions, many complications can be prevented with good primary-level chronic care. This project aims to introduce and evaluate a new strategy for integrated community-based, intensive chronic condition management in rural and remote Indigenous primary care services: Diabetes, hypertension, coronary heart disease (CHD), renal disease and chronic obstructive pulmonary disease (COPD). Proposed strategy: An intervention in 3 phases over 5 years: 1. A trial of intensive locally delivered chronic care in 6 out of 12 participating sites in FNQ with clear clinical and quality-of-life outcomes; 2. Review of lessons learned in the first phase trial, modified as necessary to reflect findings, a discussion about generalisability to the “control” sites in the trial, with an implementation plan and the development of a curriculum package for the program and; 3. In collaboration with the trial partners(QH, Apunipima CYHC and local AMS where relevant), a more general system rollout of lessons learned, with potential regional implications of a patient-centred service delivery model, including workforce and funding applications.

The aim of this clinical study is to determine the safety and effectiveness of the Cementless Total Hip System (CL2 stem/C2 cup). This will be done by collecting information and data on measured outcomes on the Total Hip System, using the Radiostereometric Analysis (RSA) method to provide early results on the implant. The intended use of this implant is for patients with degenerative joint disease who require a primary total hip replacement.

This study aims to determine if some women with early breast cancer can avoid radiotherapy treatment after breast surgery. If radiotherapy treatment can be omitted without there being any more than a very small risk of the cancer coming back in the same breast, more women may be able to avoid radiotherapy in the future. This means that these women would avoid 5 weeks of daily radiotherapy and the possible short term side effects; including, fatigue, skin redness, discomfort. Radiotherapy is associated with long term side effects which also may be avoided: discomfort in the breast, thickening of breast tissue, and very occasionally possible lung problems (pneumonitis and lung scarring), heart problems and a very small risk of radiation-induced cancer. Who is it for? This study is for women with early breast cancer that must be positive for the oestrogen receptor and/or progesterone receptor and/or human epidermal growth factor receptor. Prior to entering the main study, patients must have a magnetic resonance imaging (MRI) scan. All treatment is standard treatment except that radiotherapy after surgery to remove the breast cancer will not be given. Trial Details The study will use magnetic resonance imaging (MRI) to select women with early breast cancer for whom radiotherapy is not needed because the risk of a local recurrence (cancer coming back in the same area) is low. We are investigating whether the abnormalities found by MRI are in fact the reason that local recurrence sometimes occurs, so if nothing is found on MRI, radiotherapy may not be required.

Procalcitonin (PCT) is a marker of bacterial infection, severity of infection and response to therapy. This study aims to examine the use of this biomarker to guide antibiotic therapy in intensive care patients. We assume that a 25% reduction in exposure to antibiotic days can be produced by using a PCT guided algorithm.

Admission to an intensive care unit occurs due to the either major trauma or critical illness. Approximately 12% of admissions to intensive care unit (ICU) are for sepsis and a further 20% will develop sepsis, which has major immediate and long term effects on morbidity and mortality. If the patient survives the initial illness, a combination of the detrimental effects of the major illness stress response, nutrition, glucose levels, inflammatory mediators, immobility, hospital acquired infections and certain pharmacological agents can result in the loss of large amounts of muscle mass attributed to a proteolytic or protein degradation process or specific critical care weakness syndromes. This all results in further inability to sit, walk, swallow and breathe and a decrease in endurance in respiratory muscles, necessitating a longer time on the ventilator, increased stay in ICU, increased potential for nosocomial infection and subsequent increased morbidity and mortality. These patients are frequently depressed and anxious which has been shown to be associated with an inability to wean from the ventilator and be readmitted to intensive care when eventually discharged. Readmission will result in a further increase in morbidity and mortality. Combined, these factors escalate health care resource use during and beyond the initial hospital stay. Studies investigating the quality of life of critically ill patients on discharge from hospital have found severe psychological and physical problems. Overall ICU survivors have been found to have a lower health related quality of life. ICU patients specifically with sepsis can have a worse outcome. Preliminary evidence suggests that simple physical interventions may prevent detrimental effects of intensive care stay. Muscle stretch and passive movement can decrease levels of inflammatory markers. These indicate there is potential to prevent protein degradation and loss of muscle mass. Oxidative stress which refers to stress of any kind, in the event of limited oxygen supply, is known to induce inflammatory responses and destroy cells in critically ill patients that can lead to an increased mortality rate. In trying to prevent oxidative stress, many critically ill patients are not mobilised in the early stages of ICU admission which contributes to loss of muscle mass and decline in functional ability upon ICU discharge. During rehabilitation in the ICU, it is hard to predict the level of exhaustion or fatigue the intensity of the exercise induces on the patients. There has been some evidence to support that both locomotive and breathing muscles in sepsis show dramatic decreases in mitochondrial content, causing an acute lack of energy when the muscle is activated again following discharge. This highlights the importance of maintaining the use of respiratory and skeletal muscles during the disease process. In surviving septic patients, energy expansion is limited and exhaustive exercise can worsen this condition. Patients with sepsis demonstrate high levels of lactate in the blood which can cause fatigue. Understanding the effects of acute exercise on lactate levels in septic patients can help predict a safe rehabilitation scope. Early use of skeletal muscles can contribute to lactate clearance. Regular low intensity exercise training can also increase the rate of lactate clearance . This suggests there is potential that low intensity exercise can control lactate levels and even help reduce it. This study will investigate the associations between early rehabilitation and fatigue. When a patient initially develops sepsis it is recommended that they do not receive physiotherapy intervention (even passive movements) as it is believed that during an inflammatory process they are too unstable. Some ICU's do not include rehabilitation either in the belief it is unsafe or due to insufficient staffing levels. This study will determine whether early rehabilitation for septic patients with sepsis in ICU is clinically effective and appropriate. It will provide insight and evidence on physiological outcomes that will determine the safety of early mobilisation in critically ill patients. With evidence for early targeted rehabilitation in the ICU, there can be facilitated early functional recovery in the critically ill patients and decreased stay in the ICU.

This study aims to find out whether a method of monitoring asthma with the potential to improve adherence and control is feasible and acceptable in the general practice environment. It is hoped that this study will lead to improvements in asthma control. Prospective asthmatic patients will be invited to participate in the study and those who meet the eligibility criteria will proceed in the study. The study will involve 3 visits of no more 2 hours duration, each visit being 6 weeks apart. There will be some flexibility in that the visits can occur 2 weekdays before or after the exact scheduled date. See Attachment 1 for the study timeline. Subjects will be seen by Dr James Turton (study coordinator) who will conduct all clinical visits. Subjects will have their lung function tested and will be tested for asthma using an inhaled mannitol challenge test (Aridol (trademark)). During clinic visits, subjects will complete questionnaires relating to asthma quality of life, control and symptoms as well as being asked about their experiences during the testing process. In order to measure whether the subjects are using their inhaled medication as prescribed, subjects who use “puffers” (pressurised metered dose inhaler) will be issued with an electronic dose counter (Smartinhaler (trademark)). The Smartinhaler (trademark) device will time and date stamp each actuation – subjects will be informed of this feature of the device. Those who use an alternative dry powder inhaler type of medication will have the built-in dose counter on such devices checked at each visit. As this is a feasibility and acceptability study, both general practitioners and practice nurses will be invited to give their impressions of the monitoring process in brief semistructured interviews. The information obtained in the pilot study will inform the development of a formal research protocol to test this intervention.

This trial is a research study into an alternative treatment for calf vein blood clots (Deep Vein Thrombosis).The purpose is to investigate whether treatment with Enoxaparin produces better outcomes than standard treatment with Warfarin. We will be looking at how much of the time patients are receiving optimal doses of each of the drugs (therapeutic dose), patient satisfaction with each of the treatments and the costs associated with each of the treatments. The patients who participate in this trial will be ‘randomised’ to receive either; 1. Warfarin treatment group: Patients receive tablets of Warfarin but you will also receive Enoxaparin (fine needle injections) for the first few days while their body adjusts to Warfarin. The dose of Warfarin needs to be customised for each patient. This is done with blood tests called INR tests every few days to start with and then once per week or once per fortnight depending how your body responds to the warfarin. This is standard treatment and will probably be managed by their general practitioner (GP). 2. Enoxaparin group: patients assigned to the Enoxaparin group will receive daily injections with a very fine needle into the skin of their abdomen or legs. Most patients will be able to learn to give themselves these injections. Alternatively we could teach a friend or relative to give them to the patient, or in some cases we may be able to provide someone to come to their house to give them the injections. We think that treatment of symptomatic calf Deep Vein Thrombosis with enoxaparin may result in a higher chance of receiving therapeutic treatment (resulting from their being less variability in how patients bodies respond to be drug), a higher level patient satisfaction due to the decreased number of doctors visits, blood tests and dietary restrictions, and lower costs to the health care system than treatment with warfarin.

This National Health and Medical Research Council (NHMRC)funded clinical trial will assess the effect of an exercise-based self-management program for older people who have suffered a lower limb or pelvic fracture in the last two years. The intervention involves a combination of physiotherapy home-visits to establish a home-exercise program and the group-based the Stepping On program. Motivational interviewing and goal setting will be used to encourage behaviour change with regard to exercise and safe community mobility. Three hundred and fifty participants will be recruited from hospitals, health professional practices and general advertising. Primary outcomes are mobility-related disability, community participation and falls. Cost-effectiveness analysis will be undertaken for the primary outcomes.