ANZCTR search results

While there is currently a paucity of evidence to guide this practice, frusemide is routinely administered IV to patients presenting to Flinders Medical Centre (FMC) with either decompensated heart failure or pulmonary hypertension on the basis that expert opinion considers oral frusemide ineffective for managing these conditions. This study will assess the impact of congestive cardiac failure (acutely decompensated and compensated) and pulmonary hypertension on the oral and intravenous (IV) pharmacokinetics of frusemide, and determine whether altered pharmacokinetics may explain the variability and perceived lack of efficacy of oral frusemide in managing these conditions. It is hypothesised that these conditions will differentially affect the rate of oral frusemide absorption (i.e. the time to maximal concentration / response will be delayed), but that neither will affect the extent of absorption (i.e. bioavailability will remain unchanged). By improving the understanding of the impact of these conditions on frusemide pharmacokinetics, this study will form a framework to facilitate future research here at FMC to deliver more personalised and optimised dosing of frusemide that may combine oral and IV routes of administration, which will provide more effective management of symptoms, while reducing the time to hospital discharge.

The aim of CORE is to test if a structured co-design method (Mental Health Experience Co-Design, MH ECO) optimises psychosocial recovery outcomes for people affected by mental illnesses. MH ECO is a purposefully designed process to engage consumers, carers and service providers of adult community mental health services in re-designing aspects of services. MH ECO involves talking with consumers and carers to identify the positive and negative aspects of service and care experiences. Focus groups and interviews are conducted with consumers, carers and service providers to explore these negative aspects of care and experiences in-depth. Collaboration and co-design groups comprised of staff, consumers and carers are formed to identify ways to improve services, develop action plans and implement these. CORE is designed as a stepped wedge cluster randomised controlled trial (SWCRCT). This means that the intervention will be rolled out sequentially to participating mental health teams three clusters at a time over three waves. By the end of the trial though all clusters will have received the intervention.

Considering the background of physical and emotional stressors in labour, it is clear that there are ethical considerations in obtaining consent for research from women at this time. Although there is some literature on the validity of informed consent by women in labour, much of it is from an anaesthetics perspective only. Additionally, despite the availability of literature on women’s opinions of pregnancy and labour, there is a gap in knowledge about women’s ability to comprehend and retain information during labour. The proposed study focuses on addressing this gap and providing an evidence base regarding ethically obtaining consent, including research consent, in labour. Given the current paucity of evidence in this area, the study initially proposed is pilot in nature to ascertain the feasibility of a larger, comprehensive study and to confirm the utility of our proposed study methodology. The primary purpose of the study is to determine the capacity of pregnant women to comprehend (pregnancy and non-pregnancy related) and retain information during labour. This will be assessed, using healthy pregnant volunteers (pregnant women with no major pregnancy complications who are willing to undergo testing at approximately 36 weeks of pregnancy, in labour, and approximately 24 hours after the birth of their baby), through administration of standardised information and word lists, followed by testing of comprehension of the information and recall of the word lists. Participating women will be allocated to one of four groups: 1) Information given at both 35-37 weeks of pregnancy (at time of study enrolment) and during labour, information in written format 2) Information given at both 35-37 weeks of pregnancy (at time of study enrolment) and during labour, information in verbal (spoken) format 3) Information given only during labour, information in written format 4) Information given only during labour, information in verbal (spoken) format. Testing of immediate comprehension/recall will occur at enrolment at 35-37 weeks of pregnancy (if participant is allocated to one of the first 2 groups) and during labour (all participants). Testing of later recall (of information given during labour) will occur approximately 24 hours after the birth of the baby. The main study hypothesis is that the ability of women to comprehend and retain information will not be significantly affected by labour. Secondary aims of the study include comparing the efficacy of written versus verbal information format, and efficacy of provision of relevant information at approximately 36 weeks of pregnancy then again in labour versus information provision in labour only. The study will also consider the effect of other factors (e.g. epidural analgesia vs not, first baby or subsequent baby, woman's baseline behavioural state score) on information comprehension and recall.

AIM: The aim of this study is to assess the safety, feasibility, and efficacy of using vascular isolation chemotherapy to deliver treatment directly to the pancreas, bypassing the main blood supply throughout the body. WHO IS IT FOR? You may be eligible for this study if you are aged over 18 years, have proven locally advanced unresectable adenocarcinoma of the pancreas, and have received no prior systemic chemotherapy. Study details Once enrolled, patients will have baseline scans and will have the AVAS device implanted. The patient will be admitted to hospital up to twice per 10 day period to be treated with the pancreas directed therapy until they have received up to 12 treatments of gemcitabine + oxaliplatin, after which the device will be explanted. Gemcitabine is approved in Australia as a chemotherapy treatment for pancreatic cancer. Oxaliplatin is a component of the FOLFIRINOX regimen, which is approved in Australia for the treatment of metastatic pancreatic cancer. Neither agent has been approved for intra-arterial infusion to the pancreas using the study method and AVAS device.The patient’s tumour will be scanned 4-6 weeks after the final infusion, and the patient will be followed up for 12 months. The treatment proposed in this study is based on the hypothesis that direct arterial infusion of chemotherapy to locally advanced pancreatic adenocarcinoma whilst the blood flow to the organ is isolated could potentially yield benefits that cannot be achieved with existing treatment regimens.

To assess the capacity of a vigilance promoting agent (modafinil) to ‘perpetrate’ metabolic drug interactions that may lead to adverse effects.

This research examines the utility of Let’s Talk About Children intervention for its application in Australian mental health services. The objectives of the project are to determine the effectiveness of the ‘Let’s Talk’ program, an innovative, evidence-based program which involves training clinicians in talking to mental health clients about their children. The research will investigate the impact of Let’s Talk on parenting confidence and family functioning along with aspects of recovery (e.g. self worth, relationships, independent living) and quality of life, as compared to a control group receiving standard treatment.

Conditions of temporary glucose intolerance - such as gestational diabetes - identify people who are at risk from subsequently developing type 2 diabetes. This is important as the prompt diagnosis of glucose intolerance allows earlier treatment and a consequent reduction in complications associated with prolonged and untreated hyperglycaemia, dyslipidaemia and hypertension. The possibility that critical illness-associated hyperglycaemia (CIAH) could be a risk factor for subsequent type 2 diabetes has only been evaluated in one study. This study however has substantial limitations, which severely restrict interpretation of these data. If CIAH is a risk factor for development of type 2 diabetes, and the mechanisms underlying any glucose intolerance elucidated, survivors could be screened for diabetes and prompt appropriate therapy instituted.

The aim of this pilot study is to investigate whether pelvic floor muscle relaxation by maintaining the epidural infusion in the second stage of labour may reduce maternal birth trauma. The primary outcome measure will be pelvic floor trauma namely perineal tears, vaginal tears, anal sphincter injuries and levator ani avulsions. Secondary outcome measures include the length of first and second stage of labour, rate of instrumental delivery and caesarean section, and the clinical efficacy (analgesia, motor and sympathetic block) of the two epidural regimes to be tested. RESEARCH HYPOTHESES 1. Maintenance epidural infusion of 0.2% Ropivacaine + Fentanyl 2microgram/ml throughout the second stage of labour can reduce pelvic floor trauma. 2. Maintenance epidural infusion throughout second stage does not increase duration of labour, rate of instrumental and operative delivery. 3. Maintenance epidural infusion throughout second stage of labour provides effective analgesia with a low complication rate.

Gabapentin and pregabalin are anticonvulsants used in the management of both acute and chronic pain. They offer a potentially useful analgesic adjunct to women in the post-partum period. However, there is limited information about the transfer of these drugs in to breast milk which has lead to safety concerns over their use in breastfeeding mothers. By assigning post-partum mothers not intending to breastfeed to receive a dose of either gabapentin or pregabalin, measurements of plasma and breast milk concentrations can be made without risk of drug transfer to the newborn. This data will then be used to create pharmacokinetic models to estimate absolute and relative infant doses if used in breastfeeding mothers.

This study evaluated the effectiveness of a school-community program on Health-Related Quality of Life, physical activity, and a range of potential mediators of physical activity among adolescent girls living in low-socioeconomic rural and regional settings.