ANZCTR search results

Background: Sepsis and the systemic inflammatory response syndrome (SIRS) characterises up to 80% of critical illness in children. The fundamental pathophysiological features underpinning sepsis/septic shock (and SIRS) are changes to the vascular endothelium, which include:1) increased permeability to fluid and protein ("leaky") and, 2) increased activation ("sticky"). Therefore, monitoring the permeability of the vascular endothelium should inform clinicians about the stage and severity of sepsis and assist in clinical decision making regards fluid resuscitation and fluid balance management. Positive fluid balance i s a poor prognostic sign, but without clear science, opinion on fluid management in septic shock i s divided. We recently published data which confirms a direct role for Eph/ephrin signalling in endothelial leakage both in a mouse gut ischaemia/reperfusion injury model and in vitro in TNF-a induced vascular leakage in human umbilical venous endothelial cells. Hypotheses: That vascular endothelial function can be monitored in the intensive care unit by: (a) quantifying interstitial protein levels by microdialysis; and (b) measuring plasma levels of Eph/ephrins as endothelial activation markers. Aims: The aim of this project is to determine whether it is feasible to monitor the integrity of the vascular endothelium in critically-ill children by: a) using microdialysis to quantify interstitial protein levels; and (b) measuring plasma levels of Eph/ephrin proteins as endothelial activation biomarkers. Objectives: Our experiments are designed to improve monitoring of vascular endothelial activation and integrity, in order to guide rational fluid therapy and thereby, reduce ventilator bed days and lower mortality. Methods: In previous experiments in paediatric cardiac surgical patients, we have tested the feasibility of monitoring interstitial protein, fluid and cytokines. In these experiments, we will prospectively identify infants and children admitted to the paediatric intensive care unit (PICU) of Lady Cilento Children’s Hospital (LCCH) with sepsis/septic shock. Briefly, a microdialysis catheter (CMA60) will be inserted subcutaneously into the forearm of septic children (n = 100), and perfused with electrolyte solution and the dialysate collected for protein and cytokine determination. Serial routine blood tests will be analysed for biomarkers of endothelial activation. Approximately 100 infants and children are admitted annually with sepsis/septic shock to LCCH PICU, and are treated according to the paediatric Surviving Sepsis Guidelines. Control patients will be healthy children (n = 20) undergoing routine elective surgery at LCCH. Significance: We will introduce new diagnostic test to identify endothelial activation and a new tool (i.e. microdialysis) for monitoring vascular endothelial integrity. This may improve supportive care in the ICU and result in reduced ventilator days,

Contrast-induced nephropathy is a relatively common complication for chronic kidney disease patients who are undergoing a procedure involving contrast dye, such as a coronary angiogram, affecting around 15% of patients in this population. This condition is characterised by kidney damage that occurs a short time, usually within three days, after having the contrast procedure. We know when a patient experiences contrast-induced nephropathy by observing the levels of creatinine, an enzyme produced by the kidney, in the blood. Creatinine levels are observable from a blood test. Rates of contrast-induced nephropathy can likely be reduced using hydration and forced diuresis (increased urine output using medication). Currently, we try to reduce the incidence of contrast-induced nephropathy by hydrating patients with intravenous saline before and after the angiogram. However, it may be possible to reduce the rates of contrast-induced nephropathy even further by implementing a new regime of hydration and forced diuresis. This research project aims to identify a new, effective method of reducing rates of contrast-induced nephropathy in patients with advanced stage III, IV and V chronic kidney disease who are having a coronary angiogram at the Lyell McEwin Hospital. Patients who consent to participate in this research project will be randomly sorted in one of two groups: the control group (patients who will receive the current usual standard of care, which involves receiving saline through an intravenous drip) and the experimental group (patients who will receive a dose of furosemide for forced diuresis and euvolemic fluid replacement). Participants will not be randomised into a group until they have provided written informed consent agreeing to participate. The primary outcome for this study is development of contrast-induced nephropathy. The secondary outcomes is length of hospitalisation.

The study aims to delineate the electroanatomical remodelling in obese patients with atrial fibrillation. Importantly, it will analyse the impact of contiguous epicardial fat deposits on the electrophysiological properties of adjacent atrial tissue. It is a retrospective study based on the analysis of prospectively collected database. The patients underwent cardiac MRI prior to the ablation. Electrical remodelling and fat deposits and their association will be analysed

This observational study will evaluate smoking cessation and its impact on treatment outcome and survival in patients with head and neck cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have a confirmed diagnosis of Stage I-IV squamous cell carcinoma of the oral cavity, pharynx, larynx, nasal cavity or paranasal sinuses, for which you are deemed suitable for curative treatment at Townsville Cancer Centre. Study details Participants will undergo cancer treatment and may participate in the existing smoking cessation program as per standard of care at Townsville Cancer Centre. They will then be followed up at 3 months, 6 months, 9 months, 1 year, 2 years, 3 years and 5 years post treatment to evaluate a number of outcomes, including smoking cessation rate among smokers, treatment toxicities, and clinical response to treatment. It is hoped that the results of this study will help inform patients and health care providers and facilitate improvement in quality of care and patient compliance leading to improved disease control, survival and quality of life.

In Australia, 35,000 people have cerebral palsy (CP), and between 60-70% of these have difficulties with movement on both sides of their body. There are currently no effective interventions for children with CP that affects both sides of their body to improve their ability to use their hands, walk and perform daily life tasks. We will test the efficacy of Hand Arm Bimanual Intensive Training Including Lower Extremity (HABIT-ILE), in 126 children with cerebral palsy and compare results to usual care.

We know that asthma is a common but serious illness that causes deaths in otherwise healthy people, including young people and children. While asthma can’t be cured, it can be managed but this does require regular review of symptoms and medications, particularly because the disease can vary in severity over time, with different triggers affecting this. One strategy to improve asthma management is an asthma action plan. This is a written document that outlines how a patient’s asthma can be managed. It is individualized for each patient, and for different levels of asthma severity. It has been shown that having an asthma action plan reduces asthma mortality, yet many patients with asthma do not have a current up-to-date action plan. Part of the reason for this is that many patients with asthma only attend when they are unwell and do not attend for a planned visit to review their asthma care. Our aim is to see if a simple short messenger service (SMS) sent by the GP clinic (Banyo Clinic) increases the number of patients who attend for a planned asthma review, and as such get a current asthma action plan as part of this. To do this, we plan to design and use a computer program to search the existing general practice database and identify those patients with asthma who are eligible. Performing such a search and identification is a usual part of good practice care and clinicians regularly carry out similar audits of their databases. In this project, we additionally wish to send a SMS message to half of the population identified, inviting them to book an appointment for an asthma review. The other half of the population won’t receive an SMS and therefore will receive usual care. After two months, we will send a follow up reminder SMS to those who haven’t attended for an asthma visit with the same SMS reminder. After data collection, we will analyse the data to see if the group who received the SMS attended at a different proportion to the control group for asthma visits and supply of action plans. Our hypothesis is that, compared to usual care in the control group, receiving an automated SMS reminder prompting patients to attend for an asthma management review will: 1: Increase the attendance at the clinic for a planned asthma review 2: Increase the proportion of patients with asthma management plans The population target will be active patients with asthma who have attend the Banyo Clinic at least twice in the preceding two years who have a mobile phone number attached to their file. Eligible participants will be defined as those who have asthma in their active past history. Participants will be identified from the clinic's data base and recruited by mail from the clinic. It is estimated that there will be approximately 300 eligible people in both the control group and the intervention groups. The participants will be randomized by computer to either the intervention (SMS receiving group) or the control (care as usual) group.

Primary lymphoedema occurs in people with a genetic predisposition and manifests as long-term swelling of a body part. Current assessments provide little understanding of the composition of the underlying tissues and how they respond to treatments. No information has been available about the difference between those with and without lymphoedema with respect to age and skin properties. This study will use high frequency ultrasound (HFU) to investigate differences in skin composition and thickness in people with and without primary lymphoedema. The measures to be used include clinical tools which measure dermal properties (skin resistance and elasticity, and measures of water content and limb volume). The response of the skin to compression, a standard lymphoedema intervention, will then be assessed with HFU and clinical assessment tools, following the application of intermittent pneumatic compression. Children and adults with and without primary lymphoedema, aged between three and 40 years old, will be included. Analysis of clinical tools for a measure of equivalence with HFU findings will inform the use of clinical tools and enable translation of study findings to the clinical setting. Compression is used in healthy populations to support limbs during travel and sport: inclusion in this study of both the healthy population and the understudied childhood lymphoedema population will add to the understanding of the effect of compression on the skin for all groups and form the basis for targeted treatment guidelines. Most lymphoedema research has investigated secondary lymphoedema, despite there being strong growing evidence of underlying genetic predisposition or covert primary lymphoedema in those who develop secondary lymphoedema. The findings of this study will provide a basis for understanding the progression of primary lymphoedema and inform future primary and secondary lymphoedema research.

This clinical trial will look at which of the two therapies works best in improving thinking skills (e.g. memory and attention) which influence real world functioning. The two therapies are Cognitive Symptom Management and Rehabilitation Therapy (Cogsmart) and Computerised Interactive Remediation of Cognition – Training for Schizophrenia (CIRCuiTS). Cogmsart is a group therapy that aims to improve real world thinking skills for functioning. CIRCuiTS is a computerized program with modules including tasks of a wide range of cognitive functions. It also includes “bridging” were participants in the group reflect on how the program relates to thinking skills needed in real world functioning. What are the possible benefits of taking part? We cannot guarantee or promise that you will receive any benefits from this clinical trial; however your participation will help us better understand if Cogsmart and CIRCuiTS are effective in improves thinking skills that help in every day functioning for people who suffer from psychosis. What does participation in the study involve? This clinical trial will randomise participants in a 1:1 design, which means there is an equal chance of being in either the Cogsmart or CIRcuiTS group. Step 1 Screening Process To determine Initial study eligibility you will partake in a screening interview which will take approximately 30 minutes. Step 2 Contact You will be asked to attend group sessions either once a week for 12 weeks, with each session lasting approximately 2 hours, or twice per week for 12 weeks, with each session lasting approximately 1 hour. You will also be asked to attend three sessions as an individual. At each individual session a clinical trial research assistant/psychologist will conduct a series of clinical assessments. This will involve asking questions about your thinking and problem solving skills, thoughts, symptoms, and relationships.

The Victorian Healthy Homes Program will focus on better understanding the combined health and energy outcomes of household energy efficiency retrofit programs targeted at vulnerable householders. The evaluation will also include health economics analyses. The two overall aims for the outcomes evaluation of the Victorian Healthy Homes Program are to: (1) measure the health and energy co-benefits of improved thermal comfort among low-income households where at least one person has an existing health need and (2) provide a monetarised estimate of these health and energy co-benefits to inform future government household energy efficiency policy and programs.

The MEMO study is a randomised controlled trial that will evaluate the effects of a physical activity intervention on short-term maternal and neonatal outcomes, as well as maternal physical activity levels at 6 months and 1 year postpartum. Women up to 18+6 weeks of gestation attending the Liverpool Hospital antenatal clinic will be recruited. The primary maternal outcome is the incidence of gestational diabetes mellitus (GDM) and the primary neonatal outcome is the incidence of macrosomia (>4000g). Secondary outcomes include: physical activity level (distance walked and number of steps taken weekly), percentage of participants with GDM requiring pharmacological treatment, gestational weight gain, incidence of labour induction, mode of delivery, incidence of third or fourth degree tears, incidence of pre-eclampsia, incidence of gestational hypertension, incidence of placental abruption, incidence of postpartum haemorrhage, HbA1c at 36/37 weeks in women with GDM. The Edinburgh Postnatal Depression Scale will be administered at 24-26 weeks of gestation and again at 34-36 weeks of gestation. At 24-26 and 34-36 weeks of gestation, as well as 6 months and 1 year postpartum, maternal exercise habits and patterns will be assessed using a survey. Patient satisfaction will be assessed using the MEMO Study Patient Satisfaction Survey to be administered at 8-10 weeks postpartum.