ANZCTR search results

End stage kidney disease is increasing in incidence and many patients in Australia and New Zealand require renal replacement therapy. In 2014, 9147 patients were managed with haemodialysis (HD), and an additional 2207 patients were on haemodiafiltration (HDF) (ANZDATA 2016). Although the uptake of HDF relative to HD has increased considerably, HDF remains underutilized in Australia, especially when compared to uptake in Europe and some parts of Asia. HD performs solute clearance and volume removal by the process of diffusion, with minimal contribution from convection. HDF enhances small and middle molecule clearance through convection and diffusion, which may theoretically improve patient-level clinical outcomes. The safety of HDF has been confirmed by recently published meta-analysis. Solute clearance by convection requires substantial volumes of ultrafiltration, which in turn necessitates the administration of exogenous fluid replacement. This fluid has traditionally been reinfused either before (pre-dilution HDF) or after (post-dilution HDF) the dialyser. Post-dilution HDF is highly efficient in terms of solute clearance, but concerns have been raised regarding haemoconcentration with an increase in theoretical risk of clotting. Pre-dilution HDF minimizes the risk of haemoconcentration but provides less efficient solute removal. In recent years, two novel HDF techniques (mixed- and mid-dilution HDF) have been developed, which permit simultaneous pre- and post-dilution delivery. Mixed-dilution HDF appears to offer the most optimal balance between solute clearance efficiency and haemoconcentration compared to other forms of HDF. However, its uptake has been limited in Australia in spite of its availability. Few studies have assessed the clinical efficacy of mixed dilution HDF. Existing literature is limited by small patient numbers and limited outcome measures. This randomised crossover trial will compare convection volume, clotting, small/middle/large molecule clearance, circuit clotting and post dialysis recovery time between mixed and post dilution HDF

Atrial fibrillation (AF) is the most common abnormal heart rhythm occurring after surgery and acute medical admissions. Postoperative AF patients, discharged home in normal heart rhythm, have 5 times the stroke risk of those without postoperative AF. Postoperative AF after general surgery has been little studied. After cardiac surgery, patients frequently attend cardiac rehabilitation, and are routinely followed by cardiac professionals. The same support is seldom available after non-cardiac surgery, New AF, secondary to acute medical illness, is associated with higher long and short term mortality & stroke rates, & increased length of hospital stay. New AF occurs in 7.2% of medical ICU patients; 10% with sepsis; 44% with septic shock; & 10% with acute respiratory distress syndrome. Patients with infections have increased risk of developing new-AF (odds ratio [OR] 1.54), specifically: pneumonia OR 2.6, urinary tract infection OR 1.4, and intra-abdominal infection OR 1.6. We predict that if AF recurrence is identified early after discharge, strokes can be prevented by effective treatment. Currently, monitoring for recurrence falls mostly on the patient recognising AF symptoms. Unfortunately, AF recurrence is largely asymptomatic or has non-specific symptoms confused with normal recovery and therefore unlikely to be identified by the patient. We hypothesise patients can self-identify early recurrent secondary AF post-discharge, by taking multiple daily recordings for a month using a simple handheld smartphone ECG which provides an accurate, immediate AF diagnosis. Before commencing a larger expensive trial it is necessary to test the feasibility of the intervention, and provide an estimate of the rate of symptomatic and asymptomatic secondary AF. Results from this feasibility study will inform and refine the design of a larger intervention study. Primary aims are to provide data regarding feasibility of patient self-monitoring for AF recurrence post discharge using an iECG. The secondary end-points relate to the incidence of secondary AF following non-cardiac surgery or acute medical illness, and the incidence of AF recurrence following discharge. This cross sectional feasibility study will recruit 50 patients with new-onset post-operative AF following non-cardiac surgery, who have returned to normal sinus rhythm prior to discharge. Participants will be provided with a handheld smartphone; and will record an ECG ~5 x/day for 4 weeks. Participants experiencing possible AF symptoms will keep a diary of these and perform additional ECG recordings. Each ECG is analysed by the ‘on-device algorithm’. If ‘possible AF’ is diagnosed, the participant will take additional ECG recordings, and contact their treating doctor for review as soon as practicable. The research assistant will review each ECG and the algorithm diagnosis, and will contact participants to ensure they have appropriately followed up any abnormal ECG’s.

Atrial fibrillation (AF) is estimated to affect at least 0.25 million adult Australians and is the commonest cardiac arrhythmia world-wide. It accounts for an estimated $1.8 billion in annual direct ($1.25B) and indirect ($0.55B) healthcare costs locally. Annual hospital admissions have risen exponentially over the last 15 years, with costs for AF arrhythmia episodes alone in 2008-9 amounting to $430 million. AF causes a substantial lifetime socio-economic burden, as it causes 7,500 ischaemic strokes in Australia each year. Because the risk of stroke is determined largely by the quantitative burden of arrhythmia, treatments to lower arrhythmia burden are critically important. Obstructive sleep apnoea (OSA) is an independent risk factor for AF and more than triples the risk of stroke in AF, over and above other established risk predictors. Up to 80% of patients with AF have OSA. Current AF treatment strategies are ineffective in >50% of cases overall, particularly among individuals with OSA. Observational studies suggest that treatment of OSA may reduce arrhythmia recurrence, but no large RCTs have directly addressed this question. Reducing the >50% arrhythmia recurrence rate may only be possible when combined with structured OSA treatment. This randomised clinical trial is assessing whether routine OSA treatment in addition to a weight management program reduces AF arrhythmia burden.

The aim of this study is to examine the effectiveness of a wearable activity tracker combined with digital behaviour change resources to promote physical activity in inactive adolescents attending schools in socioeconomically disadvantaged areas. This 12-week intervention will include a commercially available wearable activity tracker and accompanying app, digital behaviour change resources delivered via social media, weekly individual and/or team 'missions', and alerts to new content and 'missions' delivered via emails and text messages. Physical activity, sedentary time, leisure time behaviours and potential mediators of behaviour change will be assessed. Assessments will be undertaken at baseline, post-test and at 6-month follow-up. Process evaluation assessments will also be undertaken.

The main purpose of this study is to investigate the efficacy of intra-nasal oxytocin (IN-OT) as a single dose and in repeated dosage as an adjunct to nutritional rehabilitation in anorexia nervosa. We specifically want to determine the effects of IN-OT on weight gain, food-related anxiety, eating behaviour, core psychopathology eating concern, weight concern, shape concern and eating restraint) and cognitive rigidity additional to the effect of weight gain over 28 days then to assess these effects at six months follow up along with changes in body mass index (BMI) and health service utilisation.

Colonoscopic polypectomy reduces morbidity and mortality from colorectal cancer. A proportion of patients undergoing colonoscopic polypectomy are on antiplatelet agents such as clopidogrel/prasugrel and ticagrelor. Current recommendations about peri-endoscopic management of these medications is individualized with guidelines generally recommending temporary interruption although the evidence behind this is poor. This randomized controlled trial aims to determined whether these antiplatelet agents can be continued for screening colonoscopy, mitigating the cardiovascular risk of temporary interruption of clopidogrel/prasurgrel or ticagrelor.

The primary purpose of this trial is to evaluate the safety and efficacy of a combination of ixazomib, thalidomide and dexamethasone (ITD) for the treatment of multiple myeloma which has progressed despite one to three lines of previous therapy. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over, and have been diagnosed with relapsed/refractory multiple myeloma for which 1-3 prior therapies have been administered. Study details All participants enrolled in this trial will receive ITD therapy, which involves taking a specific regime of oral tablets across four 28-day cycles. Participants will be assessed for adverse events and progression and survival outcomes until all patients remaining on study have been followed up for at least 12 months. . It is hoped that the findings of this study will provide information on whether the addition of ixazomib to thalidomide and dexamethason (TD) therapy is safe and effective for the treatment of relapsed/refractory multiple myeloma. Individual patients will remain on study until disease progression, unacceptable toxicity or consent withdrawal, whichever occurs first.

Post-operative care usually includes an overnight hospital stay, to ensure adequate analgesia, satisfactory haemostasis. Patients with an abscess drained will stay until the next morning with examination of the wound and the removal of the haemostatic pack. It is the fact that there is a logistic reason to keep the patients postoperatively. Baker et al illustrated their similar experience in NZ about theatre access (Baker 2009). Drainage of an abscess received a relatively low priority since it can be done by more junior staff after hours. Patients tend to have prolonged stays if access to theatre is an issue. There is currently no evidence to keep post abscess drainage patient in the hospital otherwise (Akkapulu 2014). It is time to encourage a better use of hospital resources in managing this common condition. The proposed change is to perform the drainage procedure early at the start of the ASU theatre list with minimal anaesthesia. There is evidence that for lower torso procedures, a smaller dose of spinal anaesthesia enables early ambulatory and shorter recovery period from anaesthesia. The patient is then referred to Acute Care at Home service for observation and to be discharged on the next day. Adequate analgesia and antibiotics will be dispensed prior the patient is being discharge from recovery. The ASU team can be contacted if concerns are raised by the Acute Care at Home service. The patient is then referred to Community Wound services for post-operative wound care. The complication and re-admission rate post drainage are very low (<1%) in the current management of abscesses, according to the ASU internal audit. It is important to ensure this low complication and re-admission rate continue in the new management model. The purpose of this trial is to demonstrate the safety of this new management.

AIMS To investigate the effectiveness of ketamine for the treatment of pain associated with red-back spider envenoming HYPOTHESES Ketamine will result in a significant change in the level of pain experienced by patients envenomed by red -back spider. RESEARCH DESIGN This pilot study will test the effectiveness of subanesthetic, intravenous ketamine infusions for red-back spider envenoming in a small single centre pilot trial. All patients will also receive standard opioid and nonopioid analgesia. Patients will be over 18 years old with moderate to severe red-back spider envenoming. The primary outcome will be clinically significant reduction in pain 30 minutes after administration of the ketamine infusion (compared to baseline). Informed written consent will be obtained from the patient using usual procedures prior to trial entry. All participants will receive analgesia according to a standardised protocol, commenced prior to administration of the trial drug. Patients will be cared for in an acute care area with physiological monitoring and if required intravenous parenteral analgesia as rescue medication. STUDY INTERVENTION A standard analgesia protocol will be followed prior to receiving the study intervention. The analgesia protocol will be as follows in all patients: paracetamol 1g orally PLUS oxycodone 10 mg orally. After the standard analgesia has been administered, the trial drug will be given to the patient. Subjects will be given an IV infusion with ketamine 15 mg in 100 mL of normal saline over 15 minutes. Clinical observations and patient pain score will be recorded at baseline and then post treatment at 30 minutes, one hour, two hours, four hours and on discharge. OUTCOMES: The primary outcome will be a clinically significant reduction in the severity of pain 30 min after the commencement of the ketamine infusion using the VNRS

Improving support for people with bipolar disorder is an important priority. Worldwide, bipolar disorder causes more pain and suffering than well-known conditions like heart disease and Alzheimer's. Feedback from people with bipolar disorder tells us that recovery is a personal journey about hope, understanding, empowerment and living a meaningful, satisfying and purposeful life alongside their experience of mental health conditions. Even with the right medication, people often have symptoms that continue to affect their everyday lives. Research is needed on an approach that improves individual recovery outcomes and that is useful and easy to access. This study will develop and test an eight session recovery focused group therapy programme for adults with bipolar disorder. An important focus of the project is combining what is currently known about what works with feedback from experts, including consumers. Being recovery focused, the group is an opportunity to learn from one another. Group discussion, activities and at-home tasks will be used to help group members a) increase their awareness of what matters to them; b) strengthen their ability to notice the things they are already doing that bring meaning to their life; c) identify the way(s) they respond when strong thoughts, feelings and/ or sensations show up (to help decide when/ whether these things are useful) and d) take steps towards changing the things that are less helpful in the long run and doing more of the things that bring meaning, purpose and direction. This initial study will involve 24 people with bipolar disorder. All participants will be offered the new group treatment alongside any other treatment they are already using. We will measure key signs (recovery, quality of life, symptoms) several times before and after treatment (baseline, post-treatment and 3 months post-treatment). We will also ask people to give feedback on their experience of participating in the study and the treatment they received. This will help to improve the treatment and inform a larger trial of its use in practice.