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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.

Hypothesis: Relapsed diffuse large B-cell lymphoma (DLBCL) patients who received R-CHOP as their primary therapy have a poor outcome compared to patients who received CHOP as their primary therapy. The objective of this study is to assess the impact of R-CHOP on the overall survival of autologous stem cell transplant for patients with relapsed DLBCL. The information gained may benefit patients by altering standard therapy for this patient population.

Heart failure is a deadly condition with a 5 year survival rates of 35% following index admission, exceeding the rate of many cancers Population based study in elderly patients (>65 years of age) indicates that among Heart Attack survivors over 70% patients develop heart failure by 5 years, more than 60% of which occurs in the first year. Currently there are no sufficient data to support an intensive medical treatment in patients after heart attack with normal or only mildly abnormal heart function. We hypothesize that an optimised medical treatment in patients with initial normal or mild heart dysfunction but elevated Left Ventricle size (volumes) and serum cardiac hormone levels (BNP) as markers of heart remodelling (progressive weakening) may reduce the progression of the disease, delay the onset of heart failure and ultimately reduce the risk of death.

The study aims to evaluate the natural history and health outcomes of patients with chest pain who have non-obstructive coronary artery disease. These patients traditionally have been though to have a benign prognosis and frequently have their symptoms trivialized. Despite this, persistence of chest pain symptoms is common and limited therapeutic strategies cause significant morbidity in these patients. This is in contrast patients who have obstructive coronary artery disease, who although are at increased risk of mortality, receive attention and experience symptom relief with medication and surgical interventions. There is limited longitudinal data available assessing and evaluating patients with non-obstructive coronary artery disease, especially utilizing valid and reproducible health status assessments and also comparing them to other patients who experience similar symptoms but have a clear etiology for their pain. This is important since the incidence of non-obstructive coronary artery disease may be as high as 30% of angiograms performed. Thus this study aims to evaluate the health status of patients who undergo coronary angiography for chest pain who show non-obstructive coronary artery disease and compare these to patients who undergo the procedure and show obstructive coronary artery disease, for a period of 12 months following index angiography.

The coronary sinus shares similar morphological and electro-anatomical characteristics to pulmonary veins, which have already been established as arrhythmogenic triggers of AF, but the former structure has received relatively sparse attention. The coronary sinus has been indirectly implicated in atrial arrhythmias; however, no one has systematically assessed the clinical efficacy of ablating this structure in addition to the conventional AF ablation approach. The study aims to establish irrevocably, in a blinded randomised controlled comparison, whether or not the coronary sinus plays a role in maintaining AF in non-lone/long episode paroxysmal and persistent AF.

This study is planned to investigate the effect of food on the absorption of EMA401 when EMA401 Sodium Salt is administered orally in healthy adult males (18-55 years of age inclusive) at a dose level of 50mg.

The purpose of this research project is to evaluate a plan of action designed for general practitioners and practice nurses to safely and efficiently start patients with Type 2 diabetes on insulin injections who have high sugar (glucose) levels despite taking tablets. To be eligible to take part in this study subjects must have Type 2 diabetes; be aged between 18-80 years old; are on at least two diabetes tablets at the highest doses that they are able to tolerate and that these doses have been unchanged over the last 3 months, or based on the opinion of the general practitioner who normally cares for the patient insulin, is required to ensure ensure their health health. The subject must have a HbA1c (a simple laboratory measurement on blood that reflects average glucose levels in a person's blood over the previous three months) between 7.5-10.5% which indicates less than satisfactory diabetic control; and must have never taken insulin before. Women of childbearing age must not get pregnant during the study. There will be up to 142 subjects recruited for this study across 16 sites in Victoria Australia only. Participating subjects will be commenced on insulin initially with a single injection of an insulin (Glargine) which lasts for 24 hours. The dose will then be adjusted to match the subject’s needs. If necessary, because sugar levels rise after meals despite providing an appropriate dose of the long acting insulin, a second injection of a short acting insulin (Glulisine) will be added in to coincide with the subject’s biggest meal for the day. A second purpose of this study is to determine if a new device that provides information regarding a patient’s glucose levels continuously is helpful in guiding treatment that results in better control of diabetes when compared to current methods for monitoring glucose levels by finger-prick readings. The study will be looking to see if the protocol used improves sugar levels as measured by a fall in HbA1c which will be measured at the start of a subject's involvement in the study, at 12 weeks and at 24 weeks.