ANZCTR search results

Intensive care admissions, particularly for prolonged periods are often associated with muscle weakness, deconditioning, malnutrition and impaired long-term functional status. Nutrition is a potential modifiable factor to attenuate this deterioration. However defining what optimal nutrition is for critically ill patients in order to improve their outcomes remains controversial and needs further investigation. Despite feeding protocols, internationally and at the Royal Melbourne Hospital (RMH), patients continue to receive inadequate energy and protein compared to recommended targets. Results from our recently completed observational study in Intensive Care at RMH showed that accumulating an energy debt over an Intensive Care Unit (ICU) admission is associated with decreased muscle strength, physical function and the diagnosis of ICU Acquired Weakness (ICUAW). Patients with poorer strength and suboptimal physical function had a longer ICU length of stay and a higher requirement for inpatient rehabilitation, which is associated with increased health costs. This pilot randomised controlled trial aims to determine if a feeding protocol based on energy and protein targets, using a volume approach decreases muscle wastage and improves muscle strength and functional outcomes at discharge from the ICU compared to standard care. Patients will be randomised to standard care or the targeted feeding protocol which aims to provide 25kcal per kilogram and 1.5g protein per kilogram, which is in line with international best practice guidelines. The study period is from day of enrolment until ICU day 15 or discharge from ICU. Data collection will be the same for both groups and will include demographic data, the amount of energy and protein delivered, nutritional markers; such as weight and nutritional status and outcome such as length of stay and length of mechanical ventilation. Muscle strength and physical function will be assessed by the physiotherapist using standardised methods, which have been validated in the ICU. Muscle mass will be measured using ultrasound, which is a non-invasive technique, which has been safely used in the ICU. Data from this study will assist in informing future research studies to answer important clinical questions, including; should higher protein recommendations be targeted and what are the effects of improved calorie and protein delivery on functional outcomes for patients. This study will provide feasibility data to inform large multicentre randomised control trials.

This is a prospective cohort study for patients undergoing bariatric surgery who have risk factors for NAFLD, to investigate efficacy of non-invasive tests in diagnosing and monitoring NAFLD. Patients who are already scheduled for bariatric surgery who fit criteria for likely NAFLD will be recruited to undergo an intraoperative liver and adipose tissue biopsy. Each participant will be required to attend regular follow-up appointments (0, 1, 3, and 12 months), blood tests (0, 1, 3 and 12 months), FibroScan (0, 3 and 12 months) and MRS (0 and 12 months) over a 12-month study period. Patients with significant liver disease on initial biopsy (NAFLD activity score (NAS) greater than 4, any fibrosis, any inflammation or greater than 33% steatosis) will be offered a follow-up liver biopsy at 12-months post-operatively. Liver tissues and serum will be investigated for markers that may indicate disease presence and prognosis.

This is a prospective cohort study for patients undergoing bariatric surgery who have risk factors for NAFLD, to investigate the impact of surgical weight loss on the liver. Patients who are already scheduled for bariatric surgery who fit criteria for likely NAFLD will be recruited from The Alfred Hospital, to undergo an intraoperative liver and adipose tissue biopsy. Patients with significant liver disease on initial biopsy (NAFLD activity score (NAS) greater than 4 or fibrosis score greater than F1) will be offered a follow-up liver biopsy at 12-months post-operatively. Liver tissues will be investigated for markers that may indicate disease prognosis and underlying pathophysiology, particularly immune cell markers.

This research study will assess the safety and effectiveness of a THVD-102 which is a combination of 2 currently marketed drugs, oxybutynin (7.5mg) and pilocarpine (7.5mg). The study will investigate if oxybutynin and delayed release pilocarpine together will reduce or eliminate the dry mouth side effect, whilst still reducing the symptoms of hyperhidrosis This study will look at how effective THVD-102 is in reducing excessive sweating, as well as how safe and tolerable it is compared with either oxybutynin by itself or a placebo.

Pain is a common presenting symptom in the emergency department. For moderate to severe pain, standard treatment is an intravenously administered opioid. But this can be associated with pain, inconvenience and delay as it requires the insertion of an intravenous cannula. The intranasal route of administration of opioids offers an attractive alternative as it is non invasive and does not require intravenous access. It also provides an alternative where intravenous access is difficult or not required and where nausea and vomiting prevent oral drug administration. In a number of patients intravenous access may then be completely avoided. IN Fentanyl is already commonly used in the paediatric population where more invasive methods of drug delivery (intravenous or intramuscular) may result in significant discomfort, anxiety and increased stress during a hospital visit. For adults who require larger doses of fentanyl, there is a concentrated version available (CINF), hower it is not generally used in emergency departments due to its cost. (An ampoule of concentrated INF (300mcg/mL) is $28.14 and the standard INF (50mcg/mL) is 56 cents. We have recently completed a pilot study of concentrated INF in 41 adult patients presenting to Frankston ED with moderate to severe pain. (CINF was specifically purchased for this study funded by a grant by the PHREC). Our results showed that CINF was a safe, well tolerated and efficacious in this patient population. The standard INF which is inexpensive and widely available has not been studied in adults in the acute setting as has been done in children. We are proposing a randomised equivalence study of CINF versus the SINF, which is readily available in the ED at a fraction of the cost. If equivalence is proven then standard concentration can be recommended for IN use in adults. A similar study was performed by Borland et al. in children and found that the two formulations of IN fentanyl were equally effective at reducing pain scores. Hypothesis: standard intranasal fentanyl (SINF) and concentrated intranasal fentanyl (CINF) are equally effective and safe in reducing moderate to strong pain in adult patients in the ED.

This tissue collection substudy aims to store primary tissue samples at the Breast Cancer Trials (BCT) Tissue Bank in Newcastle, NSW, for use in future research projects to investigate various aspects of cancer. Who Is It For? Patients who are randomized to the ANZ 1501 POSNOC study in Australia and New Zealand. Trial Details: If you decide to take part in the main POSNOC study, you will be asked to sign and date a consent form. As part of the study, researchers will take samples of your tumour from your breast cancer surgery for use in future research. You will not need to have any additional tissue biopsies taken as a result of giving your permission to use your tissue for this purpose. All primary tumour tissue samples will be stored at the BCT Tissue Bank for use in future research projects to investigate various aspects of cancer. All future research on stored tissue will have ethics approval and will be conducted under the supervision of the BCT Scientific Advisory Committee. Research conducted on the tissue samples will not be used for commercial gain. Tissue banking is a way of securely storing samples for use in future research when new tests may become available, so we expect to keep your samples for a long time. The use of banked tissue in future research may help researchers learn more about different types of cancers and how to treat them. The diversity within cancer tissue means that the most reliable information about breast cancer is obtained from clinical trials, as these often look at very specific types of breast cancers. Therefore, they can aim to tailor treatments to the individual patient to find the best outcome for that patient. Translational research (looking at what happens in tissue/tumour cells and then translating the findings to find the most effective way to treat a patient) is best conducted when linked to the information gained from a clinical trial. Patients will not be identified by name. The only identification of tissue will be by a patient study number, hospital or clinic number, patient initials and date of birth. All testing performed on tumour tissue will be performed anonymously. Tumour tissue will be stored indefinitely.

We wish to demonstrate that in adult patients with thoracic trauma requiring tube thoracostomy, the insertion of a sterile, flexible endoscope into the intercostal catheter at the time of insertion will allow direct visualization and guided placement of the catheter into the ideal position. The aim of this small, prospective, preliminary Phase 1 equivalent study is to refine the set-up, procedure, logistics and Trauma Team mechanics related to video-assisted ICC placement. It will be the basis for a larger, randomized trial to determine whether this new technique will remove the commonest complication of ICC insertion for trauma and lead to improved outcomes and a reduced length of hospital stay.

This study aims to reduce student experience of pain, fear and anxiety associated with school-based vaccinations. Our previous research in Perth, Adelaide and Sydney has identified that needle related anxiety is a common experience, and that for some adolescents vaccination can be very distressing. This study will determine if using an iPad application (‘app’), called BrightHearts, during the school vaccination process can improve this experience for students. It will also explore feasibility, acceptability and implementation issues associated with students using the app in this setting. BrightHearts is an award-winning artwork and mobile ‘app’, (2012 Australian Business Arts Foundation: Arts and Health Foundation Award, and 2012 National New Media Art Award, Queensland Art Gallery) developed at The Children’s Hospital at Westmead, NSW, for the purpose of teaching children relaxation techniques to cope with pain. It uses an iPad to display a colourful geometric artwork and also plays musical sounds that respond to changes in heart rate transmitted by a wireless pulse monitor worn on the child’s earlobe. Decreases in heart rate animate the sounds and visuals on the app, which is achieved by focusing on relaxing thoughts and taking big slow breaths. This gives the child feedback that their body is more relaxed. We will be inviting at least 120 Year 8 students from three schools in WA to trial the BrightHearts app during a routine school vaccination day. Students will be assigned by chance to either use the BrightHearts app or to be vaccinated without the app (as would usually occur). After vaccination we will ask all students to complete a short questionnaire on an iPad. Students will be asked questions about how they usually feel and how they felt before and during vaccination, including whether they experienced any pain, fear or anxiety. If they used the BrightHearts app they will also be asked what they thought about this. Researchers will also observe the school vaccination days and invite one immunisation nurse and one school staff member from each school to participate in an interview, which will assist in understanding whether BrightHearts is useful and to identify any implementation issues.

Despite increasing use of non-caloric sweeteners in western diets, it is not known whether habitual high intake alters glucose absorption in healthy subjects. This is critical knowledge, as an increased risk of developing type 2 diabetes may occur in regular, heavy consumers of non-caloric sweeteners, potentially due to increased uptake of glucose in the intestine. The outcome of this diet supplementation study will, accordingly, be of enormous public health interest as it determines whether intestinal sensors for sugars and artificial sweeteners (intestinal sweet taste receptors) set absorptive capacity in humans.

The aim of the study is to determine to effectiveness of a lower limb home-based exercise program compared with an upper limb home-based exercise program to prevent falls and upper limb dysfunction in older people. A definitive pragmatic randomised controlled trial (n=576) will be undertaken. People will be eligible to participate if they are: 65 years and older; not participating in an exercise program similar to either the lower limb or upper limb exercise program twice per week; do not have a cognitive impairment that would stop them providing informed consent and being able to follow instructions and understand program materials; able to speak and read English; and obtain medical clearance to participate. Recruitment will be via paid advertisements in local papers. Participants will be randomised into the lower limb exercise group or upper limb exercise group after providing informed consent and after completion of the baseline assessment (eg strength, balance and physical activity measures; self-administered questionnaire). Outcome assessors will be blinded to group allocation. The exercise programs will be delivered in three workshops (weeks 1, 4 and 12) by experienced physiotherapists. The lower limb group will be given exercises to improve balance and lower limb strength. The upper limb group participants will receive exercises designed to prevent upper limb dysfunction. All participants will be provided with a calendar to record their exercises and falls on a monthly basis; a program manual and weights. Participants in the lower limb exercise group will also receive a book/booklet about preventing falls. Participants will receive a 5-10 minute booster phone call at nine months after participation commencement. Participants will be asked to complete their exercises at home three times per week for 12 months. The weight to be used at the beginning of the program and progression of exercise intensity will be individualised and determined by the physiotherapists. Participants will be asked to return their calendars to the research team at the end of each month in the supplied reply paid envelopes.