ANZCTR search results

When children are hospitalised, they often require fluid through an intravenous line (or “drip”). This is usually because they can’t eat or drink enough to stay hydrated. The fluid is made up of water, sugar and some salts. There is uncertainty regarding the ideal sodium concentration for fluid given through a drip. Sodium is a salt which is naturally contained in the body. However, when sodium levels in the body rise or fall suddenly, it is dangerous. In rare cases, this has led to brain damage and death. Currently, when children need intravenous fluid, they are usually given a fluid that contains about half the concentration of sodium that the blood in the body naturally contains. This fluid is called 0.45% sodium chloride. For most children, this doesn’t have a bad effect. However, in some sick children, this fluid “dilutes” the blood, causing the blood sodium level to drop quickly. This side effect is rare, but is potentially very serious. We believe that we can make the fluid safer by increasing the sodium concentration. This should make it less likely that the sodium level in the blood will drop suddenly. This, in turn, should reduce the number of children who have bad side effects. We will conduct a study that compares the fluid we currently use (0.45% sodium chloride) with a fluid that contains more sodium (Plasmalyte148). Plasmalyte148 contains approximately the same concentration of sodium as is naturally contained in the blood. This is approximately double the concentration of sodium when compared with 0.45% sodium chloride. Children at the Royal Children’s Hospital who require fluid through a drip will be asked to participate in the trial. They will be randomly allocated either to 0.45% sodium chloride or to Plasmalyte148. The participants will not know the type of fluid they receive, nor will their doctors. The participants will be monitored with regular blood tests. The children will stay in the study for three days, or until they no longer require most of their hydration through a drip. We will compare blood test results for the children in each group (the 0.45% sodium chloride group compared with the Plasmalyte148 group). We will determine whether Plasmalyte148 results in more normal blood sodium results when compared with the fluid we currently use.

There is promising evidence that acupuncture improves pregnancy and live birth rates for women when administered as an adjunct to IVF on the day of ET. The aim of this study is to build a research framework to further investigate the evidence for acupuncture administered within an integrated care setting in reproductive health care. The integrative care proposal is a partnership between IVF Australia, The Acupuncture IVF Support Clinic and The University of Western Sydney. We will conduct early phase research to examine a potential mechanism for acupuncture when administered as an adjunct to IVF.

A pilot randomised study (ACTRN12609000452291) has been conducted and this current study is a larger multi-centre randomised controlled trial (RCT). This RCT will further evaluate a novel telephone-based intervention for carers of patients with advanced gastrointestinal cancer. The intervention involves five structured calls from a nurse to the carer over 10 weeks, aiming to improve psychosocial outcomes for carers. This study aims to assess the effectiveness of the intervention on carers quality of life, unmet supportive care needs, psychological distress and carer burden. This study will also ascertain effectiveness of the carer intervention to improve patient outcomes (patients unmet needs, psychological distress, quality of life and unplanned health service utilisation).

The study is designed to assess the effectiveness of removing polyps in the colon using a common technique, the biopsy forceps.

The main purpose of the study is to compare two different instruments that are used to assess and treat conditions of the small bowel.

The main purpose of the study is to test whether a faecal test done before capsule endoscopy can identify those patients that are likely to have a significant result on the capsule endoscopy.

12/11/2009. A pilot study checking the sensitivity of the Painmatcher is currently underway. This involves 20 healthy male volunteers who are randomised to receive either 100mls Normal Saline intravenously or 1g Paracetamol intravenously in a blinded crossover fashion. Pain thresholds are checked using the PainMatcher at T0, T30, T60, T120, T180, T240. Each volunteer has been trained four times prior to the first clinical session in the use of the PainMatcher. 18/07/2010. The pilot study has now been completed.

Background: Studies have demonstrated usefulness of cognitive-behavioural therapy (CBT) in managing distress in inflammatory bowel disease (IBD); however, few have focused on IBD course. The present trial aimed to investigate whether adding CBT to standard treatment prolongs remission in IBD in comparison to standard therapy alone. Methods: A 2-arm parallel pragmatic randomised controlled trial (+CBT – standard care plus either face-to-face (F2F) or online over 10 weeks versus standard care alone (SC)) was conducted with adult patients in remission. IBD remission at 12 months since baseline was the primary outcome measure while the secondary outcome measures were mental health status and quality of life (QoL). Linear mixed-effect models were used to compare groups on outcome variables while controlling for baseline. Results: Participants were 174 patients with IBD (90 +CBT, 84 SC). There was no difference in remission rates between groups, with similar numbers flaring at 12 months. Groups did not differ in anxiety, depression or coping at 6 or 12 months (p>0.05). When only participants classified as ‘in need’ (young, high baseline IBD activity, recently diagnosed; poor mental health) were examined in the post-hoc analysis (n=74, 34 CBT and 40 controls), CBT significantly improved mental QoL (p=.034, d=.56) at 6 months. Online CBT group had a higher score on Precontemplation than the F2F group, which is consistent with less developed coping with IBD in the cCBT group (p=.045). Conclusions: Future studies should direct psychological interventions to patients ‘in need’ and attempt to recruit larger samples to compensate for significant attrition when using online CBT.

This randomsied comparison trial will test the efficiacy of a novel rehabilitation (constraint induced movement therapy) whcih involves placing a glove on the unimpaired hand and intensively training the Hemiplegic hand and comparing this approach to more conventional bimanaul training in children with congenital hemiplegia.