ANZCTR search results

We aim to determine whether a purse string suture to a patients groin is more or less effective than manual pressure in preventing complications such as bleeding and bruising following ablation procedures. We intend to randomise patients in a 1 to 1 fashion to either use of a purse string suture or manual pressure over the femoral vein to achieve haemostasis following ablation procedures. We intend to randomise patients in this fashion who need anticoagulation for their procedure with the hypothesis that the purse string suture is a more efficient and more effective way to provide groin haemostasis for patients post ablation.

There is evidence that oxidative stress contributes to the pathogenesis of hypertension. The primary objective of the study was to determine if vitamin C and polyphenols, alone or in combination, can lower blood pressure in hypertensive individuals.

Summary The purpose of this study is to determine the effect of adding mitomycin (a chemotherapy drug) to best current treatment in patients with high-risk non-muscle invasive bladder cancer. Who is it for? You may be eligible to join this study if you are at least 18 years of age and have been diagnosed with non-muscle invasive bladder cancer. You should have undergone transurethral resection of the bladder tumour (TURBT) within 8 weeks prior to enrolment with no visible disease remaining. Trial details Non-muscle invasive bladder cancer is common, causes substantial suffering, and requires radical removal or irradiation of the bladder within 5 years in over 30% of people with high risk tumours despite best current treatment. Recent preliminary studies show promising results from adding mitomycin, a chemotherapy drug, to best current treatment with BCG. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current standard treatment. This involves direct instillation of the drug, Bacillus of Calmette-Guerin (BCG) into the bladder weekly for 6 weeks, and then monthly for 10 months. Participants in the other group with receive BCG and the chemotherapy drug, mitomycin, via instillation into the bladder weekly for 9 weeks, and then monthly for 9 months. Participants will be regularly assessed for up to 5 years in order to determine the effects of adding mitomycin on cure rates, survival, side effects, and quality of life.

The study is evaluating the safety and feasibility of zoledronic acid to prevent joint complication (osteonecrosis) following chemotherapy for acute lymphoblastic leukemia or lymphoma in children and adolescents. Who is it for? You or your child may be eligible to join this study if you/they are aged between 5 and 16 years and have been diagnosed with acute lymphoblastic leukemia or lymphoblastic lymphoma. Trial details: In participants more than 10 years of age the drug zoledronic acid will be intravenously infused (i.e. administered directly into the vein) on day 8 of chemotherapy and again 6 weeks later (Group 1). Children between 5-10 years of age will not receive zoledronic acid (Group 2). Both groups will be regularly monitored by blood tests and radiological interventions for up to 2 years post treatment in order to determine the feasibility and safety of zoledronic acid and the incidence of osteonecrosis (joint complication of cancer treatment).

Recent investigations into a range of native Australian species grown commercially for the food industry have emphasised the need for further research into the potential health benefits of these species, in particular, Davidsonia pruriens (Davidson Plum). An open label exploratory pilot study is proposed to investigate the anti-inflammatory and antioxidant effects of an extract of Davidson Plum in humans. Additionally, a range of physical and cognitive screening tests will be trialled that incorporate known markers of health status, including lung function, grip strength, mobility impairment, mood and quality of life. It is hypothesized that the oral administration of the study medication over 2 weeks will result in a statistically significant change in markers of antioxidant and anti-inflammatory status. Both smokers and non-smokers will be enrolled. The analysis will look at the total population and then at smokers and non-smokers separately.

We hypothesize that ICU patients have changes in the structure of their small intestinal cells that predisposes them to malabsorption of nutrients. To investigate this, we are comparing biopsies from 15 ICU patients and comparing them to biopsies from 15 healthy patients. We will analyse the samples with an electron microscope.

Postnatal depression and anxiety in women are associated with disability and diminished caregiving capacity and are of national concern. The 2009 National Perinatal Depression Initiative addresses identification of and treatment for currently symptomatic women. However, a comprehensive health service response also requires strategies to promote mental health and prevent mental disorders. To date, interventions to prevent postnatal mental health problems have had limited success, perhaps because they focused only on women and did not include fathers or the baby; addressed needs for support by providing increased professional care rather than attempting to enhance a woman’s intimate relationships, and did not take history of mental disorders into account. The common agenda of the Victorian Department of Education and Early Childhood Development; the Mental Health Division of the Victorian Department of Health, the Parenting Research Centre and the Jean Hailes Research Unit, Monash University is to optimize maternal mental health and wellbeing through evidence-based universal approaches. This inclusive Partnership is essential to the implementation and testing of a novel intervention to meet these needs. What Were We Thinking (WWWT) is a well-theorized, salient, structured, gender-informed, couples-based early postpartum psycho-educational intervention provided in maternal and child health services. It addresses the intimate partner relationship, infant behaviour management, and the mediating effects of occupational fatigue. We have promising early evidence from a controlled before and after study that WWWT prevents postpartum mental health problems in women. This cluster randomized controlled trial will establish whether WWWT is effective in reducing the 30 day prevalence of depression, anxiety and adjustment disorders in primiparous women and improving infant behaviour, mother-infant relationship and partner relationship at six months postpartum.

Clinicians consider arterial oxygen saturation (SpO2) of at least 88-90% as an acceptable target for most patients undergoing mechanical ventilation (MV). Although several experimental and clinical studies report that high levels of oxygen (O2) may be injurious, and recent RCTs show that O2 therapy titrated to lower SpO2 targets (88-94%) improves clinical outcomes in some patient groups, major observational studies show that ICU patients often receive much higher levels of oxygenation in the first 24 hours of ICU admission. Indeed, in a recently completed observational study in ICU patients on MV, we observed that high oxygenation levels were usually achieved with the use of liberal amounts of O2 in routine practice. At a teaching hospital, the 95% confidence interval for the mean time-weighted average SpO2 for the first 7 days of ventilation was 96.8-97.4% and the mean FiO2 of 0.40 or more was used to achieve mean SpO2 of >95% on 40% of the ventilated days. There are no data in literature, for adult ICU patients receiving MV, to demonstrate whether or not higher oxygenation targets (SpO2 >95%) lead to different outcomes than the alternative lower targets (SpO2 88-94%). We aim to systematically evaluate whether liberal O2 therapy is beneficial or harmful compared to a more conservative O2 therapy in critically ill patients. To help us determine the optimal size and design of a suitable trial, a pilot study will be first performed to assess feasibility of the two oxygenation strategies. Our hypothesis for this pilot study is that in critically ill patients on invasive MV, an effective separation of SpO2 levels can be achieved between the two (conservative vs. liberal oxygen targets) groups, without any significant problems or safety concerns in implementing the study protocol in different critical care settings. 100 eligible patients, will be randomly allocated to either a liberal oxygenation strategy with target SpO2 of at least 96% or a conservative oxygenation strategy with target SpO2 of 88-92%. The treating team will set PEEP as per usual practice. When FiO2 requirements are >0.80, SpO2 targets will be determined by the treating clinicians. The pragmatic nature of the trial allows flexibility in management decisions and allows the treating clinicians to alter oxygenation targets if necessary according to patient’s current clinical state. Other co-interventions such as sedation, nutrition and weaning from ventilation will follow standard practices. This pilot study will provide crucial preliminary information on the likely effects of two different target levels of oxygenation in ICU patients on invasive MV. If feasibility and safety are demonstrated, we will follow this study with a definitive RCT, the results of which will have the potential to substantially influence clinical practice in relation to O2 therapy in critically ill patients.

Anaemia associated with Chronic Kidney Disease (CKD) is due to the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin (EPO), as well as, the shortened lifespan of red blood cells (RBCs), iron and other nutritional deficiencies, infection, and inflammation. The prevalence of anaemia increases with progressive deterioration of renal function, and affects more than 90% of people with end stage renal disease. Anaemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function and exercise capacity, and increased left ventricular hypertrophy and heart failure. Treatment of anaemia reduces morbidity and may improve quality of life (QoL). Erythropoietin Stimulating Agents have been established as an effective treatment for anaemia associated with CKD and have improved the management of anaemia over alternatives such as blood transfusion. The first approved recombinant human erythropoietin, epoetin alfa, is administered 2-3 times/week for maximum efficacy. Darbepoetin alfa, has a longer half life allowing for less frequent dosing. Methoxy-polyethylene glycol-epoetin beta is a pegylated product that can be administered once monthly. PSA-EPO is a polysialylated form of erythropoietin (EPO), which is being developed for the treatment of anaemia of CKD. It is thought that polysialylation might produce an improved form of EPO, requiring a lower frequency of injection, have a slower onset of action than EPO, and potentially avert some of the side effects noted for EPO (e.g., thrombotic cardiovascular events). This is a phase 2, open-label, multi-centre and sequential dose finding trial with up to 6 treatment cohorts of 12 pre-dialysis participants per cohort will enrol between 24 and 90 participants >18 years of age with anaemia secondary to CKD, and not had treatment with an ESA in the prior 10 weeks. Two dose level cohorts are initially planned to be sequentially enrolled. Depending on the observed safety profile and pharmacological response, up to four additional open-label cohorts of 12 participants per cohort may be subsequently added to study additional and/or repeat dose levels of PSA-EPO, as determined by a safety review committee. Each participant will receive an open-label dose of PSA-EPO every 2 weeks in the correction phase, and every 4 weeks once the target haemoglobin level has been achieved, for a total of up to 8 doses. The first cohort will receive a starting dose of 1 microgram/kg body weight administered subcutaneously every two weeks. Each participant who completes the study is expected to participate for at least 17 weeks following the screening and attend weekly visits (unless advised differently by the local principal investigator) during that time.

We are implementing the WSC for residential aged care adults with dementia in the Brisbane and Toowoomba area. This project aims to rekindle positive memories of swimming in people with dementia and get them involved in a safe, regular physical activity. Swimming is an activity that has the capacity to address physical health needs, because it involves exercise; psychological health needs, because it is fun and relaxing; and social health needs, because it involves interactions with other people. Further, we aim to investigate whether participation in an evidence-based aquatic exercise program leads to changes in adults’ quality of life for adults with dementia living in residential aged care facilities, in terms of behavioural and psychological symptoms, depression and physical health. In our pilot study, conducted in Toowoomba in 2011, we showed that the WSC has the potential to positively influence sleep, appetite, pain, falls resistance, behavioural and psychological symptoms of dementia, depression, physical strength and flexibility and social functioning. The results of the pilot study showed that the WSC intervention improved left hand grip and psychological well-being, decreased the number of behavioural and psychological symptoms of dementia expressed and decreased the extent to which these behaviours distressed staff. In our current research project, we are predicting that there will be greater improvements to the quality of life of adults participating in the WSC, compared to adults receiving usual care. (For information about the pilot study, please see the following publications: (1) Neville, C., et al. (2013). "Watermemories: a swimming club for adults with dementia." Journal of gerontological nursing 39(2): 21-25; (2) Henwood, T., et al. (2012). "The Watermemories Swim Club for people with dementia." Australasian Journal on Ageing. 31(S2): 13, 23-24, 41; (3) Neville, C., et al. (2012). "The Watermemories Swim Club for People with Dementia." Journal of Ageing and Physical Activity. 20(August): S8 - 10.) Finally, we aim to create a sustainable, cost-effective, evidence-based exercise program that can be easily accessed and implemented by RACFs, independent of a research environment. To achieve this objective, we intend to disseminate manuals describing the WSC program and outlining in detail how it can be implemented, so that it may be incorporated into RACFs in other areas of Australia