ANZCTR search results

Approximately 1% of all patients (around 95,000 per year), who go to hospital acquire a urinary tract infection (UTI). It has been suggested that up to 80% of hospital associated UTS’s are caused by the use of a urinary catheter. Insertion of the catheter is an important part of reducing the risk of infection. There is wide variation in practice relating to cleaning the urethral meatus area before catheter insertion. This study intends to ascertain if cleaning the urethral meatus with saline 0.9% (Control) or an antiseptic chlorhexidine 0.1% (Intervention) reduces the instances of infection. The benefits relating to the outcomes of this study are to reduce the risk of infection and therefore it’s associated cost savings. The research hypotheses 1. When undertaking meatal cleaning prior to indwelling urinary catheter insertion, there is no difference between the use of normal saline (0.9%) and chlorhexidine (0.1%) solution on the incidence of catheter-associated urinary tract infections (CAUTIs). 2. The use of chlorhexidine (0.1%) solution for meatal cleaning prior to urinary catheter insertion is not a cost-effective intervention to reduce CAUTI. Study design A multi-site stepped wedge randomised controlled trial will be undertaken in three large tertiary hospitals (approximately 2640 participants) over a 32-week period, with a random sequential allocation of the intervention to three hospitals. The study design enables each hospital to act as its own control, which removes the potential for some confounders such as variations in hospital size and case mix and differences between public and private hospitals. Staggered commencement and duration of the intervention, either 2,4 or 6 months, supports feasibility while maintaining the rigour of the study. The number of catheter associated UTIs will be analysed using Poisson regression, with the number of cases as the dependent variable and number of patient catheter days as the denominator. This denominator will help control for changes in catheter use during the study period. The key independent variable will be the intervention.

This study aims to improve sleep and pain post operatively after rotator cuff repair. It will compare three well known medications used for pain and sleep management post operative.

Mild cognitive impairment (MCI) causes a slight but noticeable decline in cognitive abilities, and is conceptualised as a transitional prodromal stage between healthy ageing and dementia. It is estimated that up to 35 % of Australians aged 70 and older have MCI, and 15 % of those individuals will go on to develop dementia within a year. Currently, there are no treatment options for MCI, and anti-dementia pharmaceuticals are largely ineffective as they act on a single therapeutic target, which does not address the multifaceted pathophysiology of MCI. The project aims to evaluate the mechanisms of action and test the efficacy and safety of a novel multi-target treatment for MCI due to Alzheimer's disease: Sailuotong (SLT), a standardised herbal medicine formula. SLT capitalises on the multi-system approach of Chinese herbal medicine, containing multiple standardised active components including Panax ginseng, Ginkgo biloba, and Crocus sativus (saffron), and has already shown promise as a potential treatment for vascular dementia. This project will involve a 12 week randomised, double-blind, placebo-controlled trial of 180 mg/day SLT for cognitive function in people with MCI due to Alzheimer's disease. The co-primary outcome measures are episodic memory as measured by Logical Memory Story A - Delayed Recall, perceptual processing speed as measured by Digit Symbol Coding, and executive function as measured by the D-KEFS (Delis-Kaplan Executive Function System) Trail Making Test Condition 4 and the Rey Complex Figure Test (RCFT). Secondary outcome measures include: the Montreal Cognitive Assessment (MoCA), Block Design, Digit Span, Logical Memory Story A - Immediate Recall, D-KEFS Trail Making Test Condition 2, Rey Auditory Verbal Learning Test (RAVLT), Benton Visual Retention Test, 15-item Boston Naming Test, Semantic Fluency, the Controlled Oral Word Association Test, the Functional Activities Questionnaire (FAQ), Quality of Life in Alzheimer's Disease scale (QoL-AD), and the 21-item Depression, Anxiety, Stress Scale (DASS-21). We will also examine the mechanisms of action of SLT in people with MCI by assessing brain activity via electroencephalograph (EEG), autonomic activity via skin conductance and electrocardiograph (ECG), cerebral blood flow via carotid artery ultrasound, and serum inflammatory markers including IL-6, IL-1beta, and TNF-alpha.

The MOST+ project will pilot the implementation of an enhanced moderated online social therapy model within the eheadspace youth mental health services. The project aims to determine the feasibility, acceptability and safety of the MOST+ intervention for young people (16-25 yeas) who have accessed eheadspace services for mental health support. Secondary aims will assess changes in key psychosocial outcomes (i.e., psychological distress, functional impairment, satisfaction with life) and collect qualitative data for subsequent intervention refinement, using a participatory design framework. The MOST+ intervention is expected to demonstrate feasibility, acceptability and safety among the pilot cohort.

This study will be conducted in three parts: the first part will investigate the effect of a single dose of ABN019 on healthy participants; the second part will investigate the effect of a single dose of ANB019 on psoriasis patients and the third part will investigate the effect of multiple (weekly) doses of ABN019 for 4 weeks on healthy participants. The single dose study will explore different doses of the study drug given either via a subcutaneous (under the skin) injection (SC) or via an intravenous (into the vein) infusion (IV). The results from this part will be used to determine the dose and route of administration to be used for the psoriasis patient part and the multiple dose part of the study. Over the entire study a total of 87 people will be enrolled over 10 dosing groups/ cohorts. In each group of 8 healthy participants, 6 will receive the active drug, ANB019 and the other 2 will receive an equivalent placebo (an injection/ infusion that looks identical to the active drug, but contains no active drug). In the psoriasis patient group, out of the 15 patients, 10 will receive the active drug, ANB019, and the remaining 5 will receive placebo. This study is a dose escalation study meaning that the first group/ cohort will receive the lowest dose of study drug. Results will be reviewed by a safety monitoring committee after each dose strength has been tested to make sure that it is safe to continue with the next higher dose strength in the next group. The next group will not be enrolled until the safety monitoring committee have confirmed it is safe to do so. The study can be stopped at any time, based on evaluation of the side effects of the study drug. As this is a first in human study, the primary objective of the study is to assess the safety and tolerability of single and multiple doses of ANB019 administered to healthy humans.

For this acute hemodynamic study, we will measure pressure within the main pumping chamber of the heart (the left ventricle) with a plastic tube (called catheter) after treating the heart attack. In the intervention group, we will give increasing doses of a medication (Glyceryl trinitrate) through the drip for 10 minutes if there are no contraindications or concerns and will simultaneously measure the pressure within the main pumping chamber. Patients will also be given 40 mg of a fluid medication (frusemide). In the control group, pressure in the main pumping chamber will be measured for 10 minutes but no trial medication will be administered. The aim of this study is to find a dose of these medications that will reduce pressure within the main pumping chamber of the heart without affecting blood pressure or causing any side effects. These medications are routinely used during all the angiography and stenting procedures but have never been used to reduce the pressure within the heart.

Australian Medicare expenditure will continue to increase at potentially an ever-increasing rate with more complex and expensive health care and an aging population. Older people are more prone to hip fractures. In 2013, there were 23,000 cases with direct health care costs estimated at $762 Million, which is forecast to reach 32,000 cases with a cost of over $1 billion by 2022. Of this, most are spent on hospital treatment but these expenditure estimates do not include informal community care and productivity loss due to fractures. Despite advances in perioperative care, the death rate remains high in the elderly after hip fracture surgery. In Australia, there unfortunately exists a gap in this regard, since local data on such outcomes are limited in literature. Up to date, only a handful of small studies reported death rates with little research on the “dollar”. Given that hip fracture imposes such heavy medico-economic burden on our health system and current evidence base is weak, particularly in relation to its financial implications, a recent editorial has called for more international large observational studies so that cost-effectiveness analysis is possible for this population. Since identifying risk factors (and then, risk adjustment) may improve patient outcomes, a pilot study was designed for patients over the age of 70 who underwent hip fracture surgery between July 2011 and July 2015 at a Victorian Metropolitan Hospital. This study intends to find out whether some variables are independent risk factors, being increased risk of death, greater hospital costs or both. After institutional ethics approval, the hospital Database identified 1163 eligible patients and their data were retrieved. The investigators will then break down these data and assess the impact of perioperative variables on the early (30-day) deaths and associated hospital costs. To achieve the study goals, it is necessary to clearly define those to-be-tested variables, since there exist diverse definitions for certain variables, for example, early surgery is recommended in the current guidelines, but its definition varies from 24h to 72h. This is unsatisfactory because such inconsistent definitions could lead to different interpretations, and thus, inconclusive results. Accordingly in this instance, delayed surgery will be defined as operations undertaken after 48h post orthopaedic admission and then to examine whether such delay causes more deaths and/or costs, if so, delayed surgery is an independent risk factor and should be avoided in future practice. This pilot study is expected to provide valuable local data on some potentially unfavorable perioperative variables and also to fill the gap by estimating associated hospital costs for each fracture. Based on this information, a future multi-center study should facilitate and guide further research into potentially modifiable variables that may reduce the death rates and/or hospital costs of elderly hip fractures

Research Question: What are the acute (less than or equal to 7 days) effects of a single session of hot, cold or thermonetural water immersion on the time-course of inflammatory adaptive responses following a single bout of resistance training (RT) in athletes? Title: The acute effects of a hot, cold or thermoneutral water immersion strategy on the time-course of inflammatory adaptive responses to RT in athletes Specific Hypothesis: CWI will attenuate; HWI will further enhance and NWI or a passive seated rest strategy at room temperature (i.e. no-treatment control condition) will not alter the acute inflammatory adaptive responses to RT. This project seeks to enhance performance in athletes by optimising muscular adaptation and physical preparation through the periodization of post-exercise (resistance training) recovery practices (water immersion).

This study will be a prospective, multicentre, clinical study examining clinical outcomes of Knee Replacement using the Oxford Knee Score (OKS), in patients receiving Total Knee Replacement using the Triathlon Total Knee System performed using Stryker’s robotic-arm assisted surgery system Mako. Functional and radiographic outcomes will be additionally collected as part of this study. The study will be conducted in patients with non-inflammatory degenerative joint disease who require a primary Total Knee Replacement, with a minimum 2 year patient evaluation period.

The primary aim of this project is to evaluate the effect of cognitive training has on cognitive performance in older people with mild to moderate dementia. Additionally we will examine the effect cognitive training has on physical and functional performance and quality of life (participant and carer), as well as adherence to the intervention. Eighty community-dwelling older people with mild to moderate dementia will be recruited from routine health services and randomised to either intervention or control. Participants will be over 60 years old and have a carer with a minimum of 3.5 hours face-to-face contact each week. Consent will be gained from both the participant and their carer/person responsible. The intervention will consist of six months of home-based cognitive training. The cognitive training will target executive function, processing speed and attention. Both the participant and the carer/person responsible will be trained in how to use the program. Participants will be encouraged to train three times per week for 10 – 30 minutes depending on cognitive ability. The control group will receive usual care and healthy living information. Participants will be assessed at baseline, at six months (at completion of CT for intervention group) and at 12 months (six months after completion of CT for the intervention group). Falls will be recorded prospectively for 12 months using diaries (with the assistance of carers) and telephone calls. This study will provide valuable evidence in relation to the effect of cognitive training on cognitive, physical and functional performance measures in community-dwelling older people with dementia. Further, this study will also act as a pilot/feasibility study for a future study more suitably powered to determine whether cognitive training can reduce falls in community-dwelling older people with dementia.