ANZCTR search results

The monitoring of fluid status in critically ill patients is challenging. Fluid balance is often incorrect and does not take into account insensible fluid losses, which in febrile patients can add up to a litre or more/day. Weighing with beds equipped with electronic scales has been shown to be unreliable and inaccurate in ICU patients. Intravascular filling pressures are not reliably related to extravascular fluid accumulation. Oedema can only be detected once up to 4-5 litres of excess fluid have accumulated. These shortcomings in fluid assessment are particularly problematic in patients who stay in ICU for a longer period of time, where daily errors in assessment accrue to make estimates of fluid status particularly inaccurate. These technical problems are potentially clinically significance as fluid accumulation has been repeatedly identified as an independent risk factor for mortality in ICU patients. The development of novel bio-impedance vector analysis (BIVA) has recently been shown to provide a reliable, reproducible, robust, safe, and non-invasive assessment of hydration which can be performed at the bedside of critically ill patients by evaluating the bioelectrical impedance of the human body. This approach uses the administration of alternating (AC) microcurrents (microamperes) a low frequency (50kHz) with a standard four-electrode system. Such microcurrents are well below the sensation threshold for human beings. The resistance (R) and reactance (Xc) adjusted for height of the whole body provide information on the ability of the microcurrent to move from ankle electrodes and reach sensor wrist electrode. The relationship between resistance (dependent of body fluid volume) and reactance (dependent on the capacitance of membranes and tissue interfaces) allows the construction of a vector on an X-Y plot. This vector can be related to vectors obtained from >18,000 normal subjects which have been used to define reference values. These values identify states of low resistance and low reactance (fluid overload). Such individual vectors can then also be used to monitor changes in the fluid status of an individual. This approach has been applied to identify fluid overload in dialysis patients, cardiac failure patients, and, in pilot work, in critically ill patients. In this study, we propose to compare fluid management in mechanically ventilated patients expected to stay in ICU until the day after tomorrow treated with standard care during a period when clinicians are not informed of the bio-impedance measurement followed by a period in which they are informed of the measurement.

Aim: To determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of convulsive status epilepticus (CSE) in children. Design and Methods: A randomised controlled trial (RCT) comparing levetiracetam (40mg/kg, maximum 3g) with phenytoin (20mg/kg, maximum 1g) in 200 children, aged between 3 months and 16 years, presenting with CSE who are still seizing after two doses of benzodiazepines. The study will occur over three years in 13 Emergency Departments (EDs) in New Zealand and Australia associated with the Paediatric Research in Emergency Departments International Collaborative (PREDICT) research network. The primary outcome for the study is clinical cessation of seizure activity five minutes following infusion of the study drug. Secondary outcomes include; time to clinical cessation of seizure activity, need for intubation with rapid sequence induction (RSI)/intensive care unit (ICU) admission, serious adverse events, length of hospital stay, health utility, health costs, and long-term outcome.

The research aimed to develop and examine the efficacy of a selective prevention program consisting of eight sessions of online self-help which targeted clinical perfectionism. A randomised controlled trial involving 94 females without eating disorders aged 14 to 19 years was conducted. Participants were randomised into one of three groups: online cognitive behaviour therapy (CBT) for perfectionism (CBT-P), online CBT for nonspecific stress management (CBT-S) or waitlist control. CBT-P resulted in large reductions in clinical perfectionism (CPQ Factor 1 [Perfectionistic Strivings] and CPQ Factor 2 [Perfectionistic Concerns]), moderate decreases in eating disorder, anxiety and depressive symptoms, and large increases in self-esteem, with changes maintained at 6 month follow- up. Changes in clinical perfectionism, eating disorder symptoms, depressive symptoms, anxiety symptoms and self-esteem were significantly larger in CBT-P than CBT-S and waitlist control. Some clinically significant prevention effects were found, with CBT-P being superior to CBT-S in preventing deterioration of clinical perfectionism (CPQ Factor 2 [Perfectionistic Concerns]), and depressive symptoms, and CBT-P being superior to waitlist control in preventing deterioration of eating disorder symptoms over 6-month follow-up. The findings support the notion of clinical perfectionism as a transdiagnostic process and suggest that it may be a useful target for prevention of eating disorders in female youth. The use of technology to promote and engage young women in prevention programs are increasingly popular and accessible, suggesting that online programs may be useful for the prevention of eating disorders, particularly in a stepped care model.

Disability free survival after major abdominal surgery is of importance to patients and their care givers. Replacement fluid given to patients is likely to make a difference to this outcome. The RELIEF study looks at a low volume compared to a high volume fluid replacement technique to determine which results in the best outcome. What is relatively unknown is how these two different fluid replacement techniques change the cardiovascular signs that are frequently monitored as part of general anaesthetic care. These cardiovascular monitored signs can include the volume the heart pumps each beat (stroke volume) or the changes in cardiac volume over time (stroke volume variation). These cardiovascular signs are often used to guide how much fluid to give. This is because we know that if the cardiac function does not meet the needs of the extra demands from surgery, it can result in harm to the patient. For example, the patient may require additional drugs to support their circulation or suffer from poor wound healing. We aim to recruit 100 patients who are part of the RELIEF study to observe the changes in cardiovascular function using cardiac monitors. These cardiac monitors are used as part of routine monitoring care and represent established approved devices in clinical monitoring. The information from this study will help determine the usefulness of these signs for the specialist anaesthetic doctor looking after the patient. Careful and accurate monitoring of a patient’s condition can help a clinician tailor the fluid resuscitation for the patient. It can also help identify patients who may need extra support through additional drugs or closer monitoring. As this is an observational study, there will be no direct benefit to the patient. However, the information gained from the study would be of use to clinicians better look after future patients.

This trial will establish a large multi-centre prospective cohort and tissue bio-bank of unaffected first-degree relatives (FDR) of probands with RA designed to examine the role of genetic, environmental and microbial factors influencing the development and progression of RA-related autoimmunity. FDRs will be followed annually with an expected 15% likely to develop asymptomatic autoimmunity and to progress to RA within 5 years. This population cohort with accompanying genetic, environmental and immunological data will characterise more precisely people at risk of RA, allowing detection and risk stratification prior to symptoms becoming apparent.

The aims of this study are to (1) evaluate the differences in the inflammatory cytokine response to burn injury between women and men (2) determine if obesity/ adiposity contributes to the inflammatory cytokine response to burn injury. We hypothesise that (1) a quantifiable difference in inflammatory cytokines exist between women and men with burn injury, and this correlates with clinical markers of outcome (2) obesity/ adiposity influences the inflammatory cytokine response to burn injury, and this correlates with clinical markers of outcome and survival.

Neurocognitive impairments in Obstructive Sleep Apnoea (OSA) are likely related to a combination of factors including low oxygen levels during sleep (hypoxia), sleep fragmentation and possibly elevated carbon dioxide levels (hypercapnia). The latter, unlike hypoxia, has not been explored in depth and is often viewed as an innocent bystander. Early detection of hypercapnia may be an important step in the prevention of neurocognitive dysfunction in Obesity Hypoventilation Syndrome (OSA/OHS). In this study, neurocognitive function of patients with sleep disordered breathing will be assessed before and after 3 months of positive pressure mask therapy. Hypothesis 1. Patients with OHS exhibit greater cognitive impairment than obese patients with obstructive sleep apnea (OSA), but without daytime hypercapnia. 2. Patients with sleep hypoventilation have less sleep fragmentation but greater neurocognitive impairment arising from a longer exposure to hypercapnia. 3. Although correction of hypercapnia with PAP treatment will at least partially improve cognitive function, patients with OHS may remain impaired relative to treated OSA patients without hypercapnia.

Background Impaired exercise capacity and activity due to chronic obstructive pulmonary disease (COPD) is a major threat to the health of the individual and impacts on the community at large. About 330 million people have COPD worldwide and 235,000 people have moderate or severe disease in Australia alone. These people often suffer from disabling symptoms and reduced physical capacity for many years despite best medical management. Pulmonary rehabilitation is first-line treatment in people with symptomatic COPD with a strong evidence base for improved functional status, better exercise tolerance and better longer term outcomes. Recent laboratory data show that regular, low dose opioids (such as morphine) may decrease exertional breathlessness without impairing exercise capacity. Regular, low dose sustained release morphine is a potential new approach to improve further the established outcomes of pulmonary rehabilitation in COPD. Such an intervention has not been tested in a randomised clinical trial. It is important to establish that the overall net effect is positive and that benefits outweigh any harms encountered. A particular concern for many clinicians is the theoretical risk that opioids may cause respiratory depression. In steady state, at the relatively low regular doses proposed, there are no data to support this concern, but this study will specifically monitor this issue through careful collection of non-invasive measures of respiratory function, including end-tidal carbon dioxide, regularly throughout the study. Study design This is a phase III, multi-site, randomised, double-blind, parallel arm, fixed dose, placebo controlled trial of sustained release morphine (20 mg every 24 hours) or placebo during eight weeks of pulmonary rehabilitation for COPD. Randomisation will be stratified according to the mMRC score. During the study period, therapy for constipation is also given to participants with active therapy and identical appearing laxative placebo is given in the placebo arm. Data on 260 people will be required in order to complete the study with adequate power for the primary endpoint. Study population Suitable people with spirometry-verified COPD and breathlessness (between grade three and four on the mMRC scale), who are eligible for pulmonary rehabilitation and are able to give informed consent, will be recruited to participate in the study, provided they have no contraindication for opioid use. Objectives During eight weeks of pulmonary rehabilitation, the primary objective is to compare the efficacy for improving exercise capacity measured using the six minute walking test (6MWT) of sustained release morphine compared with placebo. Secondary objectives include effect on daily activity measured using an accelerometer, safety, breathlessness, quality of life (QOL), health care resource utilization, clinical and pharmacogenomic predictors of which individuals will achieve the greatest benefit from morphine, and to establish any blinded participant treatment preference. Treatment schedule Every day, participants will take three capsules (one Kapanol 20mg or placebo in the morning, and two capsules of docusate with senna or placebo). This will occur without titration and participants will continue the allocated treatment during eight weeks of pulmonary rehabilitation. ‘As needed’ open label docusate with senna will also be provided to all study participants. Assessments Week 1: demographic and clinical data, blood sample, 6MWT, daily activity (accelerometer for seven days), severity and characteristics of dyspnoea, twice daily diary, adverse events, quality of life, and blinded treatment preference. Outcome measures are repeated at the end of week eight of pulmonary rehabilitation. For 24 hours each week throughout the study: daily diary and adverse events. Definition of response: A response will be defined as an increase of 55m or more on the 6MWT. Primary endpoint: Change between week one and week eight of pulmonary rehabilitation in distance on a standardized 6MWT. Analysis: Longitudinal repeated measures mixed models with unstructured covariance matrices, two-sample t tests, and multivariable regression models will be used. Economic analysis: This will estimate incremental costs, effects and net benefit of oral sustained release morphine relative to placebo in addition to pulmonary rehabilitation from participant level data collected over eight weeks of follow up (survival to eight weeks or death, whichever is shorter) for: * resource use including bed days spent in hospital for inpatient admissions (index admission and readmissions); * professional community support utilised at home if discharged from hospital or enrolled at home, including general practitioner and specialty care service visits, * concomitant medication use; and * effects including days of survival with response, toxicity, adverse events, health related quality of life, and compliance. Bootstrapping of patient costs and effects data will be used to model decision making uncertainty related to the net benefit of oral sustained release morphine relative to placebo.

This study aims to develop, provide and evaluate a new group based activity for people who provide care for someone with Motor Neuron Disease. The purpose of this group based activity will be to create a supportive environment to share personal experiences about changes to the caregiver's life associated with caring for a person with Motor Neuron Disease. It will also provide a supportive environment to learn about mindfulness, problem solving and other support resources available. The intervention will be administered by two psychologists to a small group of caregivers.

Currently there are low rates of employment amongst people with high functioning autism/Asperger's Syndrome (HFA/AS). This project aims to develop a protocol to assist adolescents with HFA/AS in planning what they will do when they leave school. We anticipate this will result in more individuals with HFA/AS in successful long term employment. The results from this study will inform vocational rehabilitation approaches, education practices, occupational therapy practice and employment related interventions for adolescents with HFA/AS.