ANZCTR search results

Introduction and Background: Intravenous access via peripheral intravenous catheters (PIVC) in the hand or arm is frequently required during hospital care to administer hydration fluids, medicines, blood transfusions and nutrition, and to withdraw blood for testing, It is estimated up to 85% of hospital patients require infusion therapy with up to 70% of patients requiring a PIVC. Historically, research and practice has focused (understandably) reducing blood stream infection rates, particularly in central venous catheters (CVCs). Catheter related blood stream infection (CRBSI) rates in PIVCs are extremely low (0.01)6, whereas PIVC failure rates due to dislodgement, occlusion, infiltration or phlebitis sit at 26% in Australia, 38% in Spain and 53% in the USA. Occlusion and infiltration account for 35% of failure. Australian and US Standards of Practice on PIVC maintenance include statements pertaining to securement, monitoring and flushing to maintain patency and function. A range of strategies to prevent or reduce PIVC complications exist. These include preventing failure through continuous or intermittent flushes of saline or heparin saline solution, and use of heparin, antibiotic and/or ethanol locks left inside the PIVC in between uses, continuous infusion and intermittent flushing. The Infusion Nurses Society's Infusion Nursing Standards of Practice clearly define three purposes of catheter flushing; to assess catheter function, to maintain catheter patency, and to prevent contact between incompatible medications or fluids that could produce a precipitate. For effective catheter flushing, the nurse must have an understanding of technique and the equipment used within his/her institution as well as the type of catheter in use. Specific to flushing current practice recommendations included aspiration of blood prior to flush administration to ascertain patency, flushing pre and post drug administration, use of 0.9% sodium chloride solution, amount of flush to at last equal that of device, use of single dose prefilled device, administration via syringe no smaller than 10mL to minimise applied pressure. There were varied recommendations for frequency of flushing. However, clinical trials and practice surveys have identified little if any adherence to these recommendations. Translation and evaluation of current evidence for flushing of PIVCs is urgently required to reduce the unacceptably high failure rate of PIVCs. Aims and Hypothesis. The aim of this implementation study is to evaluate the impact, feasibility and acceptability of a multifaceted intervention tailored to improve post insertion PIVC maintenance - specifically, patency and flushing. Primary hypothesis: the rate of PIVC failure (as measured by a composite of occlusion , infiltration, dislodgement, phlebitis and infection) in patients who receive recommended flushing practice will be lower than those patients who receive standard care.

Objectives - The aim of this study was to evaluate the effectiveness of pharmacists completing the medication management plan in the medical discharge summary for preventing medication errors. Design - We conducted a cluster randomised controlled trial comparing pharmacist completed medication management plans in the discharge summary to standard medical discharge summaries among patients discharged following an inpatient stay under a general medical unit. Setting - This trial was conducted at an adult major referral hospital in metropolitan Melbourne, Australia with an annual Emergency Department (ED) attendance of approximately 60,000 patients Participants The evaluation included patients’ discharge summaries written in the period of 16th March 2015 to 27th July 2015. Interventions - Patients randomised to the intervention had their medication management plan completed by a pharmacist. Main outcome measures - The primary outcome variable was an erroneous discharge summary related to a medication error as identified by an independent assessor, who was not part of the patient’s admission process.

Discs in the spine are shock absorbers and are the subject of wear and tear, and on occasions collapse and pinch nerves that deliver severe pain into the leg or arm. This research is designed to look for "germs" that may be present in disc fragments that are removed at surgery. If a connection is found between "germs" and disc wear then a larger study will be planned to verify the finding. Ultimately a therapy may be used to counter the infiltration.

Patients with inflammatory bowel disease (IBD) are prescribed medications used to treat inflammation. Infliximab is an effective intravenous therapy that is used in the treatment of Crohn’s disease and ulcerative colitis. Conventionally, infliximab is given as an infusion every 8 weeks. The dose of infliximab is calculated according to weight and may differ between patients. Despite initially responding to infliximab, some patients will lose response over time, such that the drug no longer continues to work as well as it once did. Studies have demonstrated that patients on a maintenance treatment are more likely to continue to show positive responses to infliximab therapy when the blood level of infliximab, measured just prior to the next scheduled infusion (referred to as a ‘trough level’), is within an optimal range (referred to as ‘therapeutic range’). Infliximab levels are measured from a blood sample. In the past we measured infliximab levels only occasionally. This is partly because the results took time to be processed and were not available on the same day. In this project a blood test will be taken to measure the infliximab level every time patients are due for your infliximab infusion. The test to be used is able to measure the drug level within an hour at the point of care. We will then be able to modify the infliximab dose immediately, in small increments, according to the infliximab level with the aim of ensuring that infliximab levels remain within the ideal therapeutic range. The infliximab blood test and dose modification, if needed, will occur at each visit for the duration of the study (for 12 months, or 6-7 infusions). At each visit, 10mL (about 2 teaspoons) of blood will be taken from your peripheral access line to measure the level of infliximab in your blood along with other blood tests normally conducted when you have your infusion. The information from the blood tests will be used by the researchers to adjust the infliximab dose and to validate the dosing guide. Participants will be asked to provide faecal samples to measure faecal calprotectin, a protein that is secreted in the intestine of patients with inflammation of the gastrointestinal tract (this is a test we currently perform periodically; during this study we will do this test at the second visit and at the end of the study). Participants will be asked to complete a brief survey that assesses quality of life at the beginning and the end of the study, and to answer some short questions about their Crohn’s disease or ulcerative colitis

PURPOSE The primary purpose of this study is to determine the efficacy and safety of elotuzumab when combined with cyclophosphamide, thalidomide and dexamethasone (E-CTD) when compared to a standard cyclophosphamide, thalidomide and dexamethasone (CTD) triplet for the treatment of relapsed and/or refractory multiple myeloma (RRMM) WHO IS IT FOR? You may be eligible to join this study if you are over 18 years, have been diagnosed with RRMM, have had between 1-3 prior lines of therapy (may include autologous or allogeneic stem cell transplant (induction followed by ASCT and maintenance is one line of therapy), and do not have central nervous system involvement with the disease. STUDY DETAILS Enrolled participants who meet the eligibility criteria at registration will be randomised in a 2:1 ratio with 2 patients randomised to the E-CTD arm for every 1 patient randomised to the CTD arm. Treatment in both arms will include a combination of weekly intravenous infusions, and daily and weekly oral tablets. Patients will receive treatment in 28 day cycles until disease progression, unacceptable toxicity, or withdrawal or consent. Patients will be followed up every 4 weeks for MM response until disease progression, and then every 12 weeks for survival. The trial duration is estimated at approximately 4.75 years. OUTCOMES It is hoped that the findings of this trial will determine whether the addition of elotuzumab to a standard cyclophosphamide, thalidomide and dexamethasone triplet will improve progression free survival in relapsed and/or refractory multiple myeloma patients

Weight cycling (yo-yo dieting) is an ongoing battle for many obese individuals and is commonly believed to impair energy metabolism and promote future weight gain. However, scientific evidence for this idea remains scarce and mechanisms of how this occurs has not been examined in humans. The aim of this study is to investigate whether weight-cyclers have impaired energy metabolism, greater fat deposition and greater circulating and fat tissue inflammation compared to non-cyclers. 100 overweight/obese women undergoing bariatric surgery will be recruited into this study. 60 women (30/group) will be classified as weight-cyclers or non-cyclers using a validated questionnaire. Blood and fat tissue samples will be collected at the time of surgery and markers of inflammation measured in the laboratory. Clinic visits will be performed at baseline prior to surgery and at 6, 12 and 24 months after surgery. Measurements include anthropometry, body composition, resting metabolic rate and circulating markers of cardiometabolic disease (glucose, insulin, HbA1c, lipids, inflammation). Using a rigorous scientific approach and comprehensive clinical phenotyping we will address whether individuals who weight cycle have reduced energy expenditure and greater fat deposition. These results will assist in tailoring personalised weight loss treatment strategies for the over 70% of Australians affected by overweight and obesity.

The aim of the project is to examine the effect of nitrate-rich beet juice on leg blood flow during reactive hyperaemia and passive leg movement. During reactive hyperaemia and passive leg movement, blood flow is known to be highly dependent on the availability of the nitrate derivative, nitric oxide. The results of this study will determine if beet juice can enhance leg blood flow and thereby provide an effective adjunct to therapeutic exercise. The proposed study will use a placebo controlled, cross-over design to determine if beet juice can increase leg blood flow and femoral artery dilation for older adults. Specifically, we will examine leg blood flow and femoral artery diameter during reactive hyperaemia and passive hyperaemia, two tests which are known to be highly dependent on NO availability, thereby demonstrating the mechanism. Participants will attend the laboratory on three occasions: visit 1 will include participant screening, consent, and familiarisation; visits 2 and 3 will involve nitrate-rich beet juice and placebo trials (in random order). During each of the experimental visits, before and after ingestion of the beet juice or placebo, the following will be measured: blood pressure, blood plasma NO3-/NO2-, arterial stiffness, femoral artery dilation capacity, femoral artery blood flow capacity, and blood flow during passive leg movement. The results of this study will determine whether or not nitrate supplementation increases leg blood flow and vessel dilation during a reactive hyperaemia test and during passive leg movement. Ultimately, this experiment will demonstrate whether leg blood flow increases in response to improved NO availability for older adults. These findings will help to guide treatment for individuals with chronic diseases that limit exercise capacity, such as peripheral arterial disease, pulmonary disorders and heart failure. This study will also clarify the mechanism by which a simple dietary intervention may enhance leg blood flow, providing an effective adjunct to therapeutic exercise.

There is significant interest from researchers, general practitioners and the public re: the administration of Vitamin D3 supplements for health maintenance or disease treatments. The aim of this study is to evaluate the absorption characteristics of a selected group of U.S. MARKETED OVER THE COUNTER (OTC) PRO-HORMONE (D3) PRODUCTS. These products are not commercially available in Australia. As such this study proposes to evaluate the absorption characteristics of these products.

Posttraumatic stress disorder (PTSD) is a common and serious mental health problem that can have a profound impact on the person’s functioning and quality of life. Although we have effective treatments for PTSD, there are still many veterans who do not benefit from these approaches. New and innovative treatments are required. Phoenix Australia and the Monash Alfred Psychiatry Research Centre (MAPrc) are conducting a pilot study of a new intervention for PTSD known as Theta Burst Stimulation (TBS). Previous research has shown that people with PTSD may have an imbalance in the excitability, or ‘activity levels’, of cells in the brain. TBS involves the application of magnetic pulses to the head to try and change the activity level of cells in the brain. The aim of TBS treatment in PTSD is to improve the way different parts of the brain that are affected by PTSD communicate with each other, thereby reducing the symptoms of PTSD and leading to improvements in memory and thinking. To be potentially eligible to participate in the study, individuals must be a veteran, have a current diagnosis of PTSD, and be aged 18 years or above. Participation in the study involves a number of interviews, assessments and a course of TBS treatment given Monday to Friday, 15 minutes a day for four weeks at MAPrc in Prahran, Victoria. All eligible veterans will receive active bilateral TBS treatment. Participants will be assessed prior to, following and 3 months after treatment. A total of 15 participants will take part in this pilot project. This study was initiated by Professor David Forbes, Professor Paul Fitzgerald and Ms Jane Nursey and is funded by a Defence Health Foundation Grant for Medical Research.

PURPOSE This study will determine the safety and pharmacokinetics of oral arsenic trioxide (ATO) in consolidation therapy for Acute Promyelocytic Leukaemia (APML) WHO IS IT FOR? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with APML, and are in complete remission following induction with ATRA + ATO, or ATRA + ATO + idarubicin (high risk APML patients). STUDY DETAILS Enrolled participants will have achieved haematological remission following standard induction therapy with ATRA + ATO, or ATRA + ATO + Idarubucin. Patients will then undergo consolidation therapy, which will consist of two phases: Phase (i)- Approximately 8 patients will receive 7 cycles of ATRA (cycle= 7 days/week for 2 weeks; 2 weeks between cycles) + 4 cycles of IV ATO (cycle= 5 days/week, for 4 weeks; 4 weeks between cycles) with the exception of week 1 of ATO cycle #2, and week 1 of ATO cycle #4, when oral ATO will be used. The total time of consolidation treatment will be 28 weeks (7 months). Patients may have their oral doses adjusted throughout phase (i), with adjustments based on blood and urine results. The treatment regimen is designed so that patients will still receive effective doses of ATO, even if the oral ATO is completely unabsorbed by the body. Phase (ii)- The remaining 20 patients will receive 7 cycles of ATRA (cycle= 7 days/week for 2 weeks; 2 weeks between cycles) + 4 cycles of IV ATO (cycle= 5 days/week for 4 weeks; 4 weeks between cycles) with the exception of week one of either ATO cycle #1 or ATO cycle #2, and week one of either ATO cycle #3 or ATO cycle #4, when oral ATO will be used (the sequence will be determined by randomisation). The total time of consolidation treatment will be 28 weeks (7 months); Pharmacokinetics will be assessed by blood samples collected on days 1 to 2 and days 4 to 5, and urine collected on days 4 to 5 of the first week of each cycle of ATO consolidation. Safety will be assessed using Common Terminology Criteria for Adverse Events. Participants will be followed-up annually for a minimum of 3 years following the 4th cycle of ATO consolidation. OUTCOMES This trial is primarily a bioavailability study; however the efficacy and safety will be also evaluated, with the aim to determine the recommended phase 2 dose of oral ATO for use in a subsequent phase 2 trial to study efficacy.