ANZCTR search results

There is considerable concern internationally about chlamydia treatment failure. Studies have found that chlamydia treatment failure may be at least 8%, considerably higher than the 2-3% failure expected based on results of previous chlamydia treatment trials that with the exception of one trial, all used the less sensitive culture to measure antimicrobial cure. A treatment failure rate of 8% rather than 2-3% means a further nearly 3,000 in Australia and 70,000 women in the USA were inadequately treated for chlamydia in 2009, leading to longer duration of infection, increased risk of developing sequelae and continued transmission. It remains uncertain if this treatment failure is because of (1) re-infection by an untreated partner; (2) failure of the drug itself due to poor absorption from the stomach or low concentrations in female genital tissue where it is needed to work (3) the body’s immune system’s inability to fight the infection. We have received NHMRC funding to conduct a large cohort study of 450 women that aims to estimate azithromycin treatment failure for genital chlamydia infection. In order to understand failure due to (2) above (poor absorption), we propose to develop a test to measure the concentration of the drug in female cervical cellular material. We wish to determine whether azithromycin is present at the cervix in sufficient concentrations to kill chlamydia. This was done by Worm and colleagues in the early 1990s. The purpose of this study is to develop a test and specimen collection method that measures azithromycin absorption in cervical cellular material (mucus and cells) using a specimen that is practical and acceptable to women – self-collected vaginal swabs.

The purpose of this study is to determine whether there is a correlation between the height at which the veins on the back of the hand collapse, and the pressure measured by a central venous catheter in the heart (central venous pressure).The central venous pressure is used to guide how much fluid should be given to a patient, but is currently only available using invasive procedures performed in special departments within hospitals, such as intensive care. It would therefore be very helpful to be able to obtain this pressure using a non-invasive technique that could be used anywhere. This study will be performed on patients in intensive care with a central venous catheter already in place as part of their treatment. After the participant has provided consent, the head of the bed will be positioned at a slight angle (45 degrees), and the participant assisted to slowly raise their arm above the level of their chest. The veins on the back of the hand will be observed as the arm rises, and the height at which the veins collapse will be recorded. At the same time, the pressure reading via the central venous catheter that is constantly displayed on the monitor will be noted. The total time required should not be more than 15 minutes. A biostatistician will then analyse the readings to determine if there is correlation between the two measurements in each participant. There are no additional risks to participants in this study. All the risks associated with this study are related to use of the central venous catheter, which will already be present as part of their standard care.

Fibromyalgia is a complex chronic disorder affecting 2-4% of the population. It is a debilitating condition that has substantial consequences for the individual, their family and the economy. Current treatments are predominantly pharmacological interventions with either no evidence or little support for efficacy and/or associated with significant side effects. There is therefore an urgent need to develop non-pharmaceutical treatments. One potential option is pain cognition training, which is thought to work via the reconceptualization of maladaptive pain cognitions. Although a promising area, research in this field has shown only moderate effects at best. In this study, we will examine whether combining transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, to pain cognition training enhances treatment outcomes by acting on synergistic neural processes. If successful in finding that the combined treatment is better than pain cognition training alone, this study has the potential to offer better patient care than is currently available. Forty adult participants with a diagnosis fibromyalgia will be recruited for this randomized, double-blind, placebo-controlled study. Participants will be randomized into one of two treatment groups (active tDCS with pain cognition training, or sham tDCS with pain cognition training) for a 4 week daily (Monday-Friday) treatment course. At each treatment session participants will receive 20 minutes of active tDCS or sham (placebo) tDCS, followed by 30 minutes of cognition training, 3 times per treatment week (i.e. tues-thurs for each of the four weeks). Participants will complete symptom-related questionnaires and undergo a pain assessment at baseline, at the end of each treatment week (1-4), as well as at a follow-up appointment one-month following the completion of treatment. Data collected from these questionnaires and the pain assessments will be compared between the active tDCS group and placebo tDCS group using repeated measures analysis.

In Alzheimer’s disease, a peptide called amyloid-beta is elevated and aggregate forms amyloid-beta (senile) plaques/ deposits in the brain and potentially in the retina. Curcumin (an ingredient of turmeric) may increase the ability to detect the plaques in the retina. Participants will be recruited from the existing AIBL study. Images will be taken of the participants retina using a camera, Participants will then be asked to take 3 days of Vitamin E supplements and 3 days of Curcumin powder. At visit 2 (after the curcumin dosing), images will be again taken of the participant's retinas. A comparison will be made of the participants retinas pre and curcumin post dosing to determine if it is possible to detect the presence of plaques. These results will be compared to the participant's PET scan conducted during the course of the AIBL study.

Early rehabilitation of intensive care (ICU) patients is essential to reduce the residual burden of ICU-acquired weakness. While various guidelines have been published regarding safety criteria for mobilizing ICU patients (eg Hodgson et al 2014), there is little clarity regarding the safety of mobilizing patients receiving drugs which support blood pressure (vasopressors). At Canberra Hospital ICU, we have a well-established routine practice of mobilizing ICU patients (eg Green et al 2016, Leditschke et al 2012, Green et al 2009), including those receiving vasopressors. Note that ‘mobilisation’ can include standing people in a relatively passive way (eg with tilt table equipment) and / or sitting patients over the edge of the bed etc. Thus we can mobilise even sedated and / or delirious patients if required. There is very little data about the relationship between vasopressor dose and mobility level that is achievable in ICU. We wish to describe our usual practice in detail, including accurate quantification of frequency of mobilisation and corresponding dosage of vasopressors. This information will be useful not just to inform our own future practice, but also to other ICU clinicians around the world who seek more clarity on safety criteria for mobilizing patients in ICU. This study is a simple retrospective audit of our usual practice which will allow us to describe our mobilisation practices across a 3 month period. All the information required for this study is already collected routinely in the Metavision computer program in ICU, thus this study will not pose any additional burden to patients or staff. It is intended that the results of this study would be published in a reputable critical care journal, as well as presented at scientific meetings.

Shoulder disorders are a leading cause of pain and disability in our society with 1 in 3 people experiencing shoulder pain at some stage in their lives. Recurrence is common and symptoms are often persistent. The rotator cuff muscles are considered the prime source of symptoms with a diagnosis of rotator cuff tendinopathy/sub-acromial pain syndrome (SPS) accounting for approximately 30% of all diagnoses made by GPs. Physiotherapy, particularly involving structured exercises, has been shown to be as effective as surgery in this patient group and is associated with less time off work and reduced adverse events. However, definitive conclusions have not been drawn regarding which specific types of exercise are most effective in the treatment of this condition. The aim of this study is to compare the effects on pain and function of three different rehabilitation programs, each incorporating one of three types of strengthening exercises - (i) isotonic concentric (ii), isotonic eccentric and (iii) isometric rotator cuff contractions - into a structured exercise-based physiotherapy rehabilitation program in patients diagnosed with rotator cuff tendinopathy/SPS.

Successful peripheral venous catheter (PVC) insertion and the decrease of catheter related complications that result in device failure is an important clinical objective and patient outcome. Although previous studies have identified the level of skill of the PVC inserter as a risk factor for catheter failure there is a paucity of information investigating the impact of a Vascular Access Specialist (VAS). We will use a single centre, randomised controlled trial to compare the clinical and economic outcomes of PVC inserted by a VAS against those inserted by a generalist inserter (standard care). As this is a pilot study, the primary aim of this study is to establish feasibility of the protocol and the planned processes. This will help to budget and plan correctly for the larger definitive trial. We will collect data on the success of screening and recruitment strategies; test our data collection processes and technology; cost the Research Nurse time required for the trial; and finalise sample size requirements for the larger trial. Participants will be eligible for inclusion in this trial if they are a medical or surgical patient over the age of 18 and are having a peripheral intravenous catheter inserted as part of their therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to have their PVC inserted by either a Vascular Access Specialist or a generalist inserter. Daily follow ups will then be carried out by a (blinded) Research Nurse until the time of device removal.

Sucralfate has some weak evidence of being effective in the management of posttonsillectomy pain in paediatric populations. However, the current literature is limited. For this trial, 170 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 gargle 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.

Debilitating fatigue; unrefreshing sleep and poor daytime functioning are core features of many neuropsychiatric conditions including chronic fatigue syndrome (CFS) and major depression. Understanding of the aetiologies of these conditions is still incomplete and symptom management strategies have only limited efficacy. Accumulating evidence suggests that abnormalities in the function of the autonomic nervous system play a role in the sleep disturbance and chronic fatigue in these conditions. In particular, autonomic activity is characterized by neural hyper-vigilance and a marked loss of parasympathetic, vagus nerve activity that persist even during sleep. Measures of beat-to-beat heart rate variability (HRV) provide well-established, reliable indices of autonomic functioning, which consistently correlate with the severity and outcome of a spectrum of fatiguing disorders, including autoimmune and cardiovascular disease, chronic pain, depression, and CFS . For example, low HRV was repeatedly found to be a strong correlate of unrefreshing sleep, daytime fatigue and cognitive impairment in CFS. Mindfulness-based stress reduction and relaxation methods are increasingly utilised with the aim to restore autonomic balance. It is believed that the beneficial effects of these approaches are mediated via their impact on neural circuits involved in self-regulation, and on key stress-response pathways. However, individuals can have very different responses to different relaxations methods; and recent analyses revealed that some patients do not respond optimally to some. The main of the current study is to conduct a randomized control trial (RCT) to determine the efficacy and specific benefits of a 4 week personalised relaxation intervention, pre-tested to optimise the individuals' own HRV. Subjective health outcomes and parasympathetic autonomic activity (indexed by HRV) in patients with CFS and depression will be compared to a ‘monitoring only’ control condition. We anticipate that daily practice of a personalised relaxation method before sleep will be substantively more effective in improving sleep quality, daytime fatigue and functioning in both patient groups compared to treatment as usual with symptom monitoring. We further anticipate that restoration of HRV will contribute to positive health outcomes. The findings from this research will facilitate a better understanding of the pathophysiological mechanisms operating in chronic fatigue conditions.

The conservative fluid feasibility study is a phase II, prospective parallel-group (1:1) randomised controlled study (N=100). The aim is to determine if a conservative fluid management strategy, compared to usual care, can achieve a clinically significant reduction in intravenous fluid intake in critically ill adults admitted to ICU for more than 48 hours. Most general adult intensive care unit (ICU) patients who are expected to remain in ICU for more than 2 days will be eligible. Patients in the intervention (conservative) group will receive intravenous fluid therapy according to a succinct fluid practice guideline comprising bolus fluid, maintenance fluid, replacement of lost fluid, and fluid administered with drugs or other infusions. Patients in the control group will receive fluid in a usual way using a basic guideline. The primary outcome is mean hourly fluid intake from the time of randomisation until the morning of day 2 after randomisation. Secondary outcomes include adherence to the fluid guidelines and fluid balance