ANZCTR search results

The purpose of this trial is to investigate whether Aspirin and Ticagrelor have different effects on blood vessel and heart function in the setting of heart failure.

This study is a prospective, single centre, observational pilot study examining the clinical relevance and outcomes of changes in cerebral vascular autoregulation during general anaesthesia in patients presenting for non-cardiac surgery. Primary outcome is post-operative quality of recovery, and secondary outcomes are patient mortality and major morbidity. This study is a sub-study of a larger, multicenter study on the effect of depth of anaesthesia on patient outcomes (BALANCED study). Recent animal and human studies have investigated indices of cerebrovascular autoregulation (CVAR), including the tissue oxygenation index (TOx), cerebral oximetry index, haemoglobin volume index, and pressure reactivity index. These indices are derived from measuring different surrogates of cerebral blood volume or cerebral blood flow, and calculating a moving correlation coefficient between the surrogate and mean arterial pressure. Specifically, the TOx index measures cerebral tissue oxygenation using non-invasive near infrared spectroscopy (NIRS) as a surrogate of cerebral blood flow and correlation with mean arterial pressure (MAP). Thus, a TOx index can reflect CVAR changes in blood vessel diameter to maintain a constant cerebral blood flow despite changes in systemic arterial blood pressure. The TOx index is thus a novel measure of adequacy of cerebral perfusion. We hypothesise that patients who have impairment in CVAR may be exposed to episodes of cerebral ischaemia resulting in end organ dysfunction. In a number of prospective observational studies recruiting cardiac surgical patients undergoing cardiopulmonary bypass, impaired autoregulation has been associated with cerebral injury, stroke and acute kidney injury. These studies have also defined a threshold level of MAP when autoregulation is lost, as well as a range of MAP when autoregulation is optimised. However, our understanding of this association is incomplete. This study will improve this understanding in a non-cardiac surgical population who are at higher risk of complications after anaesthesia. Elderly patients greater than or equal to 60 years old admitted for major non-cardiac surgery will be monitored using NIRS to derive a real-time TOx index. We will prospectively measure patient outcomes including post-operative quality of recovery, symptoms and signs of major organ dysfunction, and mortality. Statistical analysis will be performed to determine the strength of association between patient outcomes and episodes of cerebral ischaemia as detected by TOx. This study will also provide essential data to help design a future randomised clinical trial. We would plan an interventional arm using the TOx index and the optimal autoregulation MAP value, as goal-directed therapy to minimise the time that patients are exposed to potential cerebral ischaemia.

This study will be conducted as a retrospective audit at the Townsville Hospital and will utilise existing hospital records and databases to answer a number of important clinical questions including: 1. What are the identified aetiologies for pneumonia in children in Townsville? 2. In what proportion of cases does the treatment of pneumonia conform to the published guidelines? Where it is not, is a reason for this identified? 3. Are the empirical antibiotics used in the Townsville Hospital for treatment of pneumonia in children appropriate? In what percentage of cases are organisms not sensitive to initial treatment identified (or change of antibiotics required when the patient does not respond)? 4. Are there clinical, demographic, geographic or other features which would indicate that empirical antibiotic treatments recommended in the guidelines are inappropriate in our setting?

The HeadStrong program is a mood disorders prevention program delivered to Years 9 and 10 secondary school students in NSW. The program is delivered by teachers within Personal Development, Health, and Physical Education (PDHPE) classes. Schools will be randomly allocated to the intervention or control condition with measures being administered at baseline, immediately post program completion and 6 months follow up. The goal is to determine whether the HeadStrong program causes lasting improvements in students’ knowledge, attitudes, intentions, and symptoms, with regard to mental health, well being, and help-seeking.

This project is a pilot randomised controlled trial. The main aim is to test whether it is possible to recruit and follow trial procedures in addition to working out how much benefit may come from the treatment in order to make sure enough participants are recruited for a future large randomised controlled trial. The main hypothesis is that adding cardiovascular (or fitness) training to normal rehabilitation in people who have had a stroke will be possible to do and safe for the patient. The next aim is to test the effect of the fitness training on cardiovascular fitness, walking speed and endurance; quality of life (QOL) and depression. The objective of the future randomised controlled trial will be to determine whether the moderate-intensity CV training program significantly improves the defined outcomes compared to ‘usual’ rehabilitation care. The trial will be run in an outpatient rehabilitation service of a tertiary public hospital in metropolitan Melbourne. People will be eligible to be in the trial if they have been diagnosed with a stroke more than six weeks prior; are over 18 years old; able to walk by themselves with or without a gait aid or supervision of another person; and do not have medical or other limitations to exercise. Participants currently taking medications that may affect heart rate response to exercise will be included in the trial. 20 people will be selected to receive either the treatment or normal care. People measuring outcomes won't know which group the patient is in. All participants will be tested for fitness (VO2 peak); walking speed; and quality of life and depression. The treatment group will receive two supervised sessions of moderate-intensity fitness training each week for twelve weeks. Exercise will commence at 10 minutes, and progress incrementally, as tolerated, to 30 mintues duration, prior to progression of exercise intensity. Progression of duration and intensity will be determined by trained physiotherapists, using the Karvonen method (ACSM 2010). People will either exercise with a recumbent or standard stationary bike, treadmill, stepper or cross-trainer. Participants currently taking heart rate control medications will utilise a scale of how hard they are working to monitor exercise intensity. A home exercise program of CV training will be prescribed, and gradually increased in frequency. People should progress to doing a total of 150 minutes of CV exercise in weeks 9-12 of the trial, as recommended by the NHF guidelines for aerobic exercise (Briffa et al 2006). People assigned to the usual rehab group will receive two sessions per week of a light strengthening and balance exercise program. These participants will have heart rate monitoring at five-minute intervals to maintain low-intensity exercise. Session length will be progressed from 10 minutes for 4 weeks, to 20 minutes for 4 weeks, and 30 minutes for final 4 weeks. A general home exercise program will also be given to this group.

The aim of this research is to determine the way to obtain the best possible images of the chest, abdomen, and pelvis with Computed Tomography (CT) that delivers the lowest amount of radiation to patients. We will be comparing the standard way we take images to a new protocol (protocol means the way the images are taken). The standard CT protocol of the chest, abdomen and pelvis is done in two steps, the chest and abdomen is scanned followed by the lower part of the abdomen and the pelvis. This results in a part of the abdomen being scanned twice. The new protocol that we would like to test takes all the images in one step, from the chest to the pelvis with no overlap. This is why the amount of radiation used can be reduced. The image quality of your CT using the new protocol will be compared to the image quality of the CT which was done with the standard protocol. If the image quality of this research protocol is deemed optimal, it may be adopted as the standard way of performing CT of the chest, abdomen and pelvis.

Patients undergoing surgery for mechanical heart valve replacement require post-operative anticoagulation with warfarin as they are at a higher risk of thrombosis and clot formation. To monitor for therapeutic or optimal anticoagulation status, the extent of blood-thinning is measured by a blood test called the International Normalised Ratio (INR). Depending on the type of heart valve surgery, there are two distinct recommended therapeutic INR ranges, either from 2 to 2.5 for patients receiving mechanical aortic valve replacement, or 3 to 3.5 for patients receiving mechanical mitral valve replacement. There are two issues with post-mechanical valve surgery patients that distinguish them with respect to warfarin management: (1) Their immediate post-operative warfarin sensitivity is about 50% higher than normal; (2) This increased sensitivity to warfarin returns slowly to normal over the 12 week post-operative period. Using the current empirical dosing method, that is, dosing by the prescriber using his/her clinical judgement, some patients require up to 3 weeks monitoring, when the average for attaining a stable therapeutic INR in patients other than post heart valve surgery with warfarin is less than 1 week, using the current, proven initiation protocols. We therefore propose that two revised age-adjusted, warfarin management protocols be used, specifically designed to meet the needs of the post-mechanical aortic and mitral heart valve surgery patients. These protocols, designed to cover the 12 weeks post-surgery period, will include the first four days of warfarin dosing not previously discussed by Meijer, where we will reduce warfarin dosing by 30% for patients receiving a mechanical aortic valve replacement, so as to achieve an INR range of 2 to 2.5, and reduce warfarin dosing by 25% for patients receiving a mechanical mitral valve replacement so as to achieve an INR of 3 to 3.5. Then from day 5, if the optimal anticoagulation status or therapeutic INR has reached a relative degree of steady-state or stability, we have added to the protocols the incremental dose adjustment approach described by Meijer et al., whereby dosing is adjusted up or down on a percentage basis depending on the INR. For patients not in the therapeutic INR range by day 5, empirical dosing will be recommended until INR steady state is achieved before the incremental dose adjustment approach as defined by Meijer et al, is applied.

The overarching aim of this study is to examine the process of organ donation decision-making and to determine whether changes in requesting practices may effect changes in consent for donation, and family-based outcomes. This study uses a single arm design with current ‘controls’ to explore an intervention, the procedure for providing information and requesting consent for donation, that uses new agreed best practice procedures led by specially trained intensive care health professionals. Discussing the possibility of organ donation with families of patients who are potential organ and/or tissue donors is usual care by staff in the intensive care unit. The study intervention is a staff education and training module intended to provide a framework and preparation for select critical care staff to conduct organ donation discussions in line with best practice. Donation decision-making processes will be compared before (‘control’) and after (‘intervention’) staff have received this training. In addition to standard bereavement follow-up provided by the hospital, senior next of kin who declined donation will be offered bereavement aftercare provided by the NSW Organ and Tissue Donation Service. This longer term bereavement support is usual care for those who agreed to donation and will be offered to those who declined donation. Evaluation of the intervention will include audit data on adherence to core elements of the requesting process. Critical care staff will be asked to complete a form to record details of request conversations and procedures. Clinical and administrative data will be collected from databases and paper records. Senior next of kin who agreed to bereavement aftercare will be invited to participate in a structured telephone interview 90 days post bereavement to evaluate their perceptions of their donation decision, and to provide some personal information. A sample of 400 potential donation scenarios are possible over the intervention study period from approximately 10 NSW hospitals.

Pneumonia, an infection of the lung, is a common reason for admission to hospital, and worldwide is still the leading cause of mortality in children under 5 years. Relatively rarely, a complication of this is infected fluid surrounding the lung, termed an empyema. Empyemas are very rare in metropolitan areas, but anecdotally are more common in rural and remote regions. This is currently unreported. This audit will help us to find out exactly how many children are at risk, and which mode of management appears to confer the shortest hospital stay and with minimal complications.

At 7-10 years after total hip replacement, this study will determine the incidence of bone loss around a primary total hip prosthesis with a metal head and polyethylene liner, as determined by CT, as well as the wear of the polyethylene and the movement of the acetabular cup, as determined by plain radiographs. The study will also examine the incidence of dislocation and other symptoms of hip instability, as well as the reasons for revision or re-operation. In addition, the study will show if there are any differences in these outcomes between prostheses with standard 28 mm and large 36 mm femoral heads.