ANZCTR search results

Insulin delivery via an insulin pump can mimic the normal action of the pancreas more closely than multiple daily injections of short and long acting insulin. With the development of continuous glucose monitoring devices, glucose levels can be measured continuously over 24 hours. These two devices have now been linked by a computer to create an “artificial pancreas” or Closed Loop system. The computer’s function is to calculate accurately the amount of insulin to be delivered by the pump based on the sensor glucose readings. Overnight Closed Loop systems have been tested in both children and adults with Type 1 diabetes. Overall, the results show that the systems are safe and effective. However, important gaps in our knowledge remain to be explored. For example, while exercise is healthy for people with diabetes it can result in unpredictable changes in glucose levels that may challenge an artificial pancreas. In addition, different types of exercise have differing effects on glucose levels in people with Type 1 diabetes. Short intense bursts of exercise (anaerobic exercise) may initially increase glucose levels while less intense exercise (aerobic exercise) tends to reduce glucose levels. This study aims to collect information about how well the Closed Loop system is able to control glucose levels of people with type 1 diabetes when they undertake aerobic and anaerobic exercise. Outcomes of interest will include the risk of hypoglycaemia and time in healthy glucose range. Insulin and counter-regulatory hormones will also be measured providing insights into changes in glucose levels with exercise in Type 1 diabetes patients.

This RCT investigated the efficacy of massage therapy as a non-pharmacological, non-invasive treatment for people with SCI. It found that massage therapy can provide improvements in secondary conditions of SCI such as pain and fatigue

The aim of this study is to identify obese patients who are at risk of developing Obesity Hypoventilation Syndrome (OHS) by investigating the relationship between daytime measures (including supine hypercapnia (elevated carbon dioxide levels when lying flat), distribution of body fat, and lung volumes) with the presence of hypoventilation during sleep. Hypothesis: Supine hypercapnia is a useful marker for identifying sleep hypoventilation, an early sign of the development of OHS.

Alcohol consumption by Australian women, especially younger women, has been steadily increasing together with the prevalence of episodic or binge drinking by such subjects. The increase in alcohol intake has been occurring in the setting of an increased public health recognition that the regular consumption of 1-2 standard alcoholic drinks per day may confer protection against coronary artery disease. However, the balance of potential risks and benefits for alcohol consumption have, more often than not, been generated on the basis of data from studies in men. This is especially true with respect to the effects of alcohol on blood pressure and hypertension. There is continuing controversy with respect to the amount of alcohol which will influence blood pressure in women and uncertainty as to the direction of any effect. Population-based epidemiological studies suggest that low level alcohol consumption (4-7 drinks per week) may lower blood pressure in women while higher levels of consumption (2 or more drinks per day) have been associated with higher levels of blood pressure. The present proposal will directly test these assumptions by measuring BP over 24 hr on a carefully controlled basis in women who are drinking at these levels over 4-week periods. The results will be compared to levels of BP measured after 4 weeks of abstinence from all alcohol.

The current epidemiological literature suggests that regular higher consumption of alcohol raises blood pressure (BP). In view of the well-known association between BP and cardiovascular disease (CVD), and the fact that patients with diabetes have increased risk of CVD, this trial tests the hypothesis that a reduction in alcohol intake in Type II diabetic patients who are regular drinkers, will reduce cardiovascular risk.

ARI in children is a leading cause of hospitalisation and preventable death and repeat episodes in infancy are associated with an increased risk of chronic lung disease. Cough in children, commonly triggered by a viral ARI is a substantial cause of morbidity and associated health and societal economic costs. Chronic wet cough in children implies increased airway secretions and lower airway infection. This novel proposal aims to determine whether a validated evidence-based cough algorithm initiated at the development of chronic cough, defined as >4 weeks duration, following an ARI improves clinical outcomes in Indigenous children compared to standard care.

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.