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Cardiac surgery is one of the most common complex operations conducted on millions of patients worldwide every year. Advances in bypass technology and surgical techniques improved mortality and outcomes after cardiac surgery. Patients presenting to cardiac surgery are older, suffer multiple comorbidity and likely to undergo more complex operations. Therefore, significant morbidity continues to be associated with cardiac surgery including acute kidney injury and failure, neurological injury such as stroke, delirium or cognitive dysfunction, cardiac failure and arrhythmias such as atrial fibrillation and respiratory failure. These complications, in combination or individually, leads to increased hospital stay and increased disability and functional dependence. Dexmedetomidine is a strong sympatholytic agent that has been used as a sedative and adjunct for procedural sedation. Animal models of global hypoxic brain injury, myocardial ischaemia reperfusion and contrast induced kidney injury showed potential protective effects, possibly due to reduced apoptosis and inflammatory response. A Cochrane systematic review concluded that the perioperative use of Alpha2 agonist reduced mortality and myocardial ischaemia with most pronounced effect seen in vascular and cardiac surgery. In the context of cardiac surgery, randomised trials of dexmedetomidine has been shown to reduce delirium, acute kidney injury and postoperative ventilation time. Retrospective propensity score analysis suggested that dexmedetomidine reduced hospital and 1 year mortality in patients undergoing cardiac surgery. In concert, these studies suggest that perioperative use of dexmedetomidine may reduce cardiac surgery associated complications, including mortality and likely to days home and disability free following high risk cardiac surgery. Aims: 1. Assess the safety and efficacy of perioperative dexmedetomidine in high risk cardiac surgery. 2. Inform the design and conduct of a phase III multicentre study on the clinical effectiveness of dexmedetomidine in cardiac surgery Design: Multicentre Single blind placebo controlled RCT Population and sample size: 80 patients in 4 sites Inclusion criteria: consenting adult patients undergoing on bypass cardiac surgery with 1. Combined surgery (CABG + valve) or (valve) or aortic arch surgery OR 2. Chronic Kidney disease class III and IV with estimated GFR 1559 mls/min/1.72m2. Intervention: Dexmedetomidine infusion at 0.7 mcg/kg/hr will commence at the induction of anaesthesia and be continued throughout the surgery. Dose will be reduced by 0.4 mcg/kg/hr at skin closure and continue until clinically not required. Concomitant intervention: Standard anaesthesia. Primary outcomes: A composite outcome of number of days home, alive and disability free at 28 days following surgery will be the primary study outcome.

There is currently a lack of high quality evidence to inform the management of prosthetic joint infections (PJI), an uncommon, but potentially devastating complication of joint replacement surgery. Prosthetic Joint Infection in Australia and New Zealand Observational Study (PIANO) is a multicentre, prospective observational study of prosthetic joint infections in Australia and New Zealand. The study aims to describe the clinical, laboratory, microbiological and radiological features of patients presenting with prosthetic joint infections and their management and subsequent outcomes.

This is a cross body trial to compare the safety and efficacy of topical tranilast in morphea. This agent is an established pharmaceutical with a good safety record which has been available in Japan and Korea for 20-30 yrs but has never been marketed in Australia. It has approval for the management of keloid and hypertrophic scars in these countries. There are publshed reports of efficacy in morphea. The trial involves the application of a corticosteroid cream to one involved site on the body with the application of a cream containing both corticosteroid and the trial agent at an alternate site for a period of 3 months. Monthly clinical and laboratory assessments will be performed over this time. All currently prescribed treatments will be continued during this period.

This research project is being conducted to look at how safe and well tolerated a new drug called DUR-928 is when given as an oral dose to subjects with Nonalcoholic Steatohepatitis (NASH), when compared to healthy volunteers. The study will look at the study drug’s effect when given as a single dose at 2 different dose levels. The pharmacokinetics of DUR-928 will also be studied; this is done by measuring the amount of DUR-928 in the blood at different times throughout the dosing periods, allowing us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream). The pharmacodynamics will also be studied; this is done by measuring the amount of selected biomarkers in the blood at different times throughout the dosing periods, allowing us to evaluate the effect of DUR-928 on the body.

Sucralfate has some weak evidence of being effective in the management of posttonsillectomy pain in paediatric populations. However, the current literature is limited and has not reported side effect profiles. This pilot trial aims to identify any major side effects that would prevent the use of sucralfate as adjunct analgaesia. For this pilot, 10 children will be recruited preoperatively and randomised to either receive sucralfate or placebo solution. This will be in addition to the standard Monash Health posttonsillectomy analgaesia protocol. The children will gargel and swallow 5 mLs of the study mixture four times a day. Parents will be provided with a set of questionnaires to complete for each postoperative day, consisting of the parents’ postoperative pain measure, the functional limitation scale and the FACES pain scale – revised. They will also be asked about their child’s quality of sleep, how much analgaesia the child has received, any contact with medical practitioners required, whether their child tolerates the study mixture and any side effects they notice.

Many patients admitted to the Intensive Care Unit (ICU) with a critical illness suffer from acute kidney injury. Acute kidney injury often requires the use of an artificial kidney therapy known as Continuous Renal Replacement Therapy (CRRT). CRRT requires the establishment of a blood filled circuit (tubing) to enable the pumping of blood through an artificial kidney (also called a filter). This artificial kidney system often fails to work because blood clotting occurs. Ideally, this artificial kidney should function without clotting for at least 24 hours. Some recent clinical observations and studies have suggested that premature clotting of the circuit may be due to interruption to blood flow by mechanical factors such as the position of the vascular access device, patient movement and positional changes. These mechanical factors cause reductions in blood flow or cessation of blood flow. This reduction in blood flow causes blood flow stasis promoting clot formation and eventual circuit failure. There is great variability in the setting for the speed of the blood (blood flow rate) through the circuit amongst ICU’s in Australia. The blood flow rate may be influential in the promotion of clotting due to the mechanical factors described earlier. We proposed to make some comparisons between two blood flow rates (150 mL/min vs. 250 mL/min) currently being used within the ICU at Austin Health. The aim of this audit is to prospectively collect information and identify any advantage (if any) of one particular blood flow rate setting over another. This pilot and feasibility study completed data collection in Feb, 2015. Statistical analysis has required more advanced support than originally anticipated but is now complete. Only preliminary study results have been disseminated via presentation at the Annual Scientific Meeting of Intensive Care in Auckland.

The primary purpose of this study is to develop and implement an integrated eHealth platform to support and enable cancer survivors to achieve and maintain improved health and well-being and better cancer outcomes, and to assess the feasibility and acceptability of the system. Who is it for? You may be eligible to join this study if you are aged 18 or over and are either currently receiving cancer care (including follow-up care), or have recently been diagnosed with cancer and scheduled to commence cancer treatment at one of the participating sites. Study details Participants will have access to the eHealth system which assesses symptoms, emotional well-being and unmet needs. Participants will have access to a range of self-management websites based on their survey responses. Staff will receive a patient report with clinical recommendations. Patients and oncology staff will have access to the system for 3 to 4 months. Patients will then be asked to complete a survey and an interview regarding their use and acceptability of the eHealth system. Staff will be asked to complete an interview only. It is hoped that the findings of this pilot trial will provide information on the feasibility and usefulness of such a tool in improving the health and well-being in cancer patients.

A Randomised control single centre trial for patients undergoing bilateral TKR for the treatment of osteoarthritis performed at the Mater Health Services North Queensland between December 2013 and June 2015. The trial is comprised of 2 phases, phase 1 focuses on the economics of Conventional Dry Dressings (CDD) for patients undergoing TKR. Phase 2 captures the cost of Negative Pressure Wound Therapy (NPWT) vs CDD as well as patient satisfaction in patients undergoing Bilateral TKR under three surgeons. Each knee shall be randomised to receive either dry dressings or negative pressure wound dressings. Surgeons and patients will be blinded to which leg will receive the CDD and the NPWT until wound closure and the dressings are to be applied. Patient satisfaction will be assessed in the form of a diary and questionnaire. Economy of dry dressing changes on the ward and in clinic is to be calculated with ward checklists. Data in regards to BMI, American Society of Anaesthesiologist Physical status classification, and Charlson Comorbidity Index will be collated as well. The follow up period is two weeks or untill the first outpatient review as per surgeons standard of care.

The purpose of this research study is to learn more about the safety and tolerability of a new experimental drug, SM04646 This is the first time that SM04646 will be administered to humans. Samumed Pacific is developing this small molecule inhibitor (SM04646) of the Wnt pathway to be used for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The pathway is a network of switches in the body that helps to determine what cells become. For this study, a solution containing SM04646 will be nebulised, or made into a fine mist, for inhalation in up to 25 healthy subjects. This study will try to find out the maximum dose of SM04646 that can be safely inhaled by healthy subjects without causing a strong cough response. The purpose of this study is to learn more about the safety and activity of SM04646. to obtain information on how the body absorbs, distributes and removes the drug from the body (pharmacokinetics), blood samples will be taken to measure the concentration of the study drug over time in the body. This study will check safety by measuring heart, lungs, liver and kidney function, number of blood cells and vital signs. Subjects will be treated with a single inhalation of study drug SM04646, on Day 1 be observed for safety for a total of 90 days. The first subject will be administered SM04646 and observed for a minimum of 7 days. The safety of the first subject dosed will be assessed before further subjects are dosed. Subjects will be enrolled into 4 dose groups, with 4 - 5 subjects in each group. Each group will receive a single inhalation of nebulised SM04646 inhalation solution (10 minutes) at doses ranging from 0.7 mg to 20.0 mg. . Eligible subjects will be dosed in a staggered fashion such that no more than two subjects will receive study drug on the same day.

The injury of the anterior cruciate ligament (ACL) is a typical injury of the knee joint that occurs during sports. According to recent studies, ACL injury mechanisms are multifactorial, resulting from the interplay of various factors. One potential injury risk factor of the ACL is limited ankle dorsiflexion. Dorsiflexion range of motion may alter lower-extremity landing mechanics in a manner, which predisposes athletes to injury. Our purpose is to clarify the effect of stretching by evaluating landing task biomechanics related to ACL injury before and after ankle dorsiflexion stretching.