ANZCTR search results

One-third of youth presenting to GPs and paediatricians complain of physical/somatic problems (e.g., recurring headaches, stomach-aches) that have no physical cause. These complaints are termed functional somatic syndromes (FSS). Importantly, up to 80% of youth with FSS also experience emotional disorders. However, to date, FSS interventions have solely focused on pain management, whilst overlooking the co-occurring anxiety and depressive disturbances. This is problematic given these children are at high-risk for experiencing chronic psychopathology into adulthood. The aim of this RCT is to test the efficacy of the CoolKids and Adolescent Health (psychological therapy) program which is a newly developed program specifically tailored for distressed children (7-17 years) struggling to cope with somatic-health complaints. Given the CoolKids and Adolescent Health program is also designed to concurrently manage both somatic and anxiety/depression symptoms, it is hypothesized that this program is expected to: i) lead to significant reductions in somatic, anxiety and depressive symptoms and improvement in quality-of-life compared to a wait-list control group. ii) The effects will be retained at 6-months and 9-months follow-up.

Orthopaedic surgeons frequently claim that the administration of muscle relaxants (NMBA) in patients under general anaesthesia facilitate surgery, especially when significant forces may be required (e.g. dislocation of hip joint, femoral realignment during operation of femoral fractures). However, despite the fact that NMBA are frequently used during general anaesthesia for orthopaedic surgery, no evidence for their benefit on operating conditions exists. Therefore, this trial aims to investigate the influence of NMBA on traction forces during hip replacement surgery. 20 Patients scheduled for hip replacement surgery under general anaesthesia will be included in this trial. Patients will receive a standard general anaesthetic. Patients for this form of hip replacement surgery are generally operated on a special operating table with the patients feet placed in shoe-like brackets. This allows the application of significant tension and torque to the patients operated leg in order to enable the surgical preparation of the hip joint for the prosthesis. With the help of a measurement instrument (Newton Meter installed within the traction mechanic of the operating table) we will measure the forces required to extend a patient's leg to facilitate surgery. Thereafter, an NMBA (rocuronium = most often used NMBA at RPH) will be slowly administered to finally achieve muscle paralysis. During the time of paralysis development, traction forces on the leg will be measured. Aim is to investigate whether NMBA can significantly reduce the forces required during hip replacement surgery.

The aim of this study is to evaluate the impact of a change to universal patient decolonization in ICU based on emerging evidence. Universal decolonization is the therapeutic administration of bathing with a chlorhexidine impregnated cloth daily to all ICU patients with the goal of decreasing hospital-acquired bloodstream infections and the acquisition of multidrug resistant organisms. Recent studies have shown that such administration of daily chlorhexidine bathing to ICU patients is more effective than targeted decolonization or screening and isolation in reducing rates of MRSA clinical isolates and bloodstream infection from any pathogen. In response to these findings there is now consensus among ICU specialists, infectious diseases specialists and the Pharmacy Department that a policy of universal decolonization should be implemented in the Austin ICU beginning in early 2014. Bathing will be completed according to manufacturer instructions. In brief, washcloths will be used in sequential order to rinse all body surfaces with the exception of the face during bathing with the 2% chlorhexidine-impregnated cloths in order to avoid exposure of the mucous membranes to the eyes and mouth. A manufacturer-produced video will be used to instruct nurses on the application of these cloths. Such washing will be applied within 4-6 hours of admission and, thereafter, daily at practically convenient times and at intervals no greater than 24 hours. Our primary outcome is the incidence of ICU acquired blood stream infections during the observation period. All relevant data on patient characteristics, diagnoses and illness severity will continue to be collected as is routine in ICU. All microbiological data will continue to be collected as is routine or clinically indicated in ICU.

Numerous animal studies have shown that bolus or fast fluid infusion increases blood loss and mortality compared to a slow fluid infusion. Consistently, a high quality human randomised controlled trial also demonstrated that rapid crystalloid infusion increased mortality and complications in children with severe infections compared to those who received no bolus infusion. To date, no human studies have explored the effects of bolus fluid infusions and the duration of these effects on haemodynamic changes, biochemical, immunological and hormonal responses compared to those effects induced by slow infusions. This study is the first human randomised controlled trial to investigate the effects of bolus (fast) and slow infusion of crystalloid (clear) fluids in healthy volunteers. Participants will be randomly assigned to either a bolus (fast) infusion or a slow infusion group. The controlled venesection (removal) of 10 ml/kg Ideal Body Weight of blood will be conducted over a 15 minute period. Following that and after 30 minutes, participants will be resuscitated with 13 ml/kg of a either a bolus (fast) infusion (10 minutes), or a slow infusion (30 minutes) with a balanced crystalloid solution. After a 60-minute measurement period, the participants’ blood will be re-infused over a further 30-minute period. After 2 weeks, the participants will be crossed over to the other arm. Primary end point: Oxygen delivery, which can easily be measured by using a validated non-invasive haemodynamic monitor (Edwards Life Science ClearSight Device), a device that is used routinely as standard of care at Austin Health. Secondary endpoints: The effects of the rate of fluid resuscitation on mean arterial pressure, systemic vascular resistance, vascular reactivity index, biochemical, immunological and hormonal responses will also be investigated in similar timeline. Study Hypothesis: A slow crystalloid infusion has a more beneficial effect on oxygen delivery than a bolus (fast) crystalloid infusion in healthy volunteers (age 18 to 45 years) with induced compensated shock. No of participants: 9 Setting: A single centre University teaching hospital. Safety: Detailed and stringent safety guidelines will be followed in accordance with advice from the Department of Haematology at Austin Hospital, Austin Hospital Blood Bank, Victorian Red Cross, and the Department’s of Anaesthesia and ICU. Each experiment will conducted by a senior anaesthetist, in a theatre environment, with the appropriate monitoring and safety equipment to effectively and safely conduct this study. Clinical significance: These results will used to generate hypotheses and establish outcome benchmarks for future controlled trials that will directly influence how patients with haemorrhagic shock are optimally resuscitated.

To continuously evaluate glucose concentrations and electrocardiogram changes in patients with pre-existing diabetes who are discharged from the Intensive Care Unit (ICU), so as to evaluate whether a relationship exists between asymptomatic hypoglycaemia and cardiac arrhythmias in this cohort.

Many variables impact upon a patient's satisfaction with the way their pain is managed in the Emergency Department (ED). These include the length of time before they receive analgesia, the nature of the analgesia, ancillary means of managing pain (e.g. ice packs), staff courtesy etc. In three studies, we have observed that a high level of patient satisfaction with their pain management is associated with the provision of ‘pain advice’ i.e. being told by the ED staff that ‘pain management is important and that the patient should tell the staff if they have pain’. Providing pain advice (as above) should be part of the routine management of patients with pain. However, this does not always happen and standard care may be sup-optimal. In this study, we will randomize patients into two groups: 1) standard care, 2) standard care plus provision of pain advice (as above). We hypothesize that the provision of pain advice will result in increased patient satisfaction measured ~48 hours after discharge from the ED. If demonstrated, this will be powerful evidence that will inform the development of best-practice pain management guidelines. This is a low risk study. All patients will receive at least standard care. The intervention arm will receive a component of care that should be provided as part of standard care but is often not provided.

The next few decades will see a substantial increase in the prevalence of diabetic retinopathy, a common and debilitating microvascular complication of diabetes that progresses largely as a result of poor blood sugar control. Our study responds to the urgent need to assist patients with type 2 diabetes and early diabetic retinopathy to achieve optimal blood sugar control to reduce the risk of irreversible vision loss. We expect our novel personalised routine eye consultation, which is based on evidence-based approaches for behaviour change, to educate and promote long-term behaviour change and lead to clinically significant reductions in blood glucose in a cost effective manner. In this project, we will conduct a randomised controlled trial to investigate the clinical, cognitive and behavioural outcomes of our novel personalised eye consultation model, using the individual’s own retinal images and evidence-based strategies for behavioural change, to motivate and support patients with diabetic retinopathy and poor blood glucose control.

The aim of this study is to assess the safety and tolerability of the HSV-2 DNA vaccine. We will also investigate whether the vaccine is immunogenic i.e. if it has any effect on the immune system and what type of response is induced. The study will also investigate the vaccine’s effectiveness in combating and/or treating HSV-2 infection

This study assesses the impact of Clonidine a commonly prescribed medication for the treatment of Attention Deficit hyperactivity Disorder (ADHD) on behavioural and brain imaging measures of cognition. Specifically, it measures the impact of Clonidine on key behaviours that are altered in ADHD including, response inhibition, attention and error processing.

The study will assess the relative and combined effects of volunteering on seniors’ physical and mental health. Comparisons will be made between a cohort undertaking volunteering activities and a cohort in a control condition (customary activity). A multi-method intervention approach will be used to obtain experimental and attitudinal data from individuals aged 60+ years. Data will be collected over six months to capture information relating to activity initiation, continuance, and attrition. The study will identify the health benefits for older people of different levels and types of volunteering and the major factors impacting the recruitment and retention of older volunteers.