ANZCTR search results

A prospective study was performed in a tertiary referral centre ED, where the number, types, and volumes of fluid bolus (FB); Indications of fluid bolus.; and their perceived success rates were recorded. The physiological effect of these FBs on blood pressure (MAP, mmHg), heart rate (HR, per minute), respiratory rate (RR, per minute) and temperature (Temp, °C) were recorded before, and 10 minutes, 1 hour, 2 hour and 4 hour after the FB. We hypothesized that, in a tertiary level ED of an Australian teaching hospital, FB therapy will have varied indications and have limited physiological efficacy.

Cerebral palsy is the most common cause of physical disability in childhood. Physiotherapy is an important patient focused healthcare delivery intervention that is necessary to improve functioning of muscles, walking and in the prevention of deformities. The life-long impact of cerebral palsy is higher than many conditions because of the early age onset. Hence physiotherapy needs to be provided from an early age to influence not only muscular structure (such as strength and flexibility) but also neurological structures such as the brain - which can learn and change when given the right stimulus to do so. There has been a recent paradigm shift in how to train and promote walking in people with neurological conditions. Activity and intensity of training are crucial and much of this has been drawn from neurological research and spinal cord injury research. It is increasingly recognized that teaching the pattern of walking is important to stimulate the central pattern generators – the intrinsic and reflexive pathways in our neurological system that guide movement. This approach is not well understood in the area of cerebral palsy but given the theoretical foundation combined with our clinical experience and observations that have demonstrated feasibility and potential efficacy, a controlled larger scale study is necessary. This is particularly relevant because technology is now increasingly available in the community but is supported by limited evidence. Evidence based approaches are necessary to ensure ethical use of limited funds. The significance of this research recognizes that one in three children with cerebral palsy cannot walk and rely on equipment aides and physical support from carers. Hence programs focusing on walking will address known issues due to sedentary behaviour in children with cerebral palsy and in the prevention of obesity and pain. Such interventions will improve independence and functioning hence reducing the burden of care, which is by far, accountable for the highest economic impact of this condition. Therefore training to walk at an early age even with the use of mobility aides such as walking frames actually translates to increasing and maintaining movement, strength, independence, function, participation and well-being to reduce the burden of care not just for short term gain but well into the future as children become adults. This approach combines the knowledge and principles needed to improve muscular structures, central pattern generators and an avenue to improve walking speed and endurance in young children with cerebral palsy even though children are classified as having lower gross motor function (GMFCS III, IV and V). The primary aim of this research is to determine if robotic assistive rehabilitation improves functional mobility in children with cerebral palsy who usually require assistance to walk and reduced burden of care for their parents and families.

The overall aim of the current study is to examine social and emotional brain regions involved in healthy ageing using a double-blind placebo controlled intranasal oxytocin design and MRI techniques involving fMRI.

Elastomeric pumps are balloons filled with antibiotics. As they deflate they deliver the medication to the patient at a constant rate. Patients that require long term antibiotics, such as as for infections in the bone, often use these pumps. These patients may also require treatment in the hyperbaric chamber for their infection. This study will compare the flow rate of the elastomeric pump in the hyperbaric chamber with its flow rate outside the hyperbaric chamber. If the pump flows at the same rate in the hyperbaric chamber there will be no need for disconnecting the pump before hyperbaric treatment. This will improve patient care by reducing the risk of infection and ensure appropriate antibiotic dose administration.

The purpose of this study is to understand how different foods can affect blood glucose responses when a young person sits for a long period of time and when that sitting is interrupted with light exercise breaks. We hypothesise that the glucose responses will be minimised when healthier foods are eaten and when the sitting is interrupted by light exercise breaks.

This study aims to investigate the safety and tolerability of intramuscular DVC1-0101 injections, at both high and low doses, when compared with placebo, in patients with intermittent claudication or critical limb ischaemia secondary to peripheral arterial disease. The secondary aims are to investigate the efficacy of DVC1-0101, compared with placebo, in promoting revascularisation in the target leg limb. Enrolled participants will receive a single dose (30 intramuscular injections) in the target limb. They will be required to return for regular outpatient visits over a 6 month follow up period. A final follow up phone call will be conducted at 12 months post-dose. Safety and tolerability will be measured via physical examination, clinical laboratory results and monitoring of injection site reactions. Secondary efficacy outcomes include exercise treadmill testing to obtain absolute claudication distance (ACD) and patient self-reported walking impairment data. Blood samples will be collected for pharmacodynamic measurements. The results of the study will be used to develop DVC1-0101 as a treatment for patients with claudication and critical limb ischaemia.

This is a first in human, randomized, placebo-controlled, double-blind, single dose, escalating dose and Multiple-Dose study of the safety and pharmacokinetics of RA101495 in healthy volunteers to evaluate safety of RA101495. There will be up to 5 single dose cohorts with doses of 0.05, 0.10, 0.20, 0.40 and 0.80 mg/kg. There will be up to 2 multiple dose cohorts with doses of 0.20 and 0.40 mg/kg. Study drug will be administered on Day1 for single dose cohorts and on Day1-7 for multiple dose cohorts as a single SC injection and the amount of drug given will depend on the dose of the cohort and the weight of the subject. Each cohort will be dosed a minimum of 7 days for single days cohorts and 14 days for multiple dose cohorts after the first subject in the previous cohort received the last dose. If 2 or more subjects administered RA101495 in a dose cohort experience a dose-limiting toxicity, dose administration in that cohort will stop and escalation to the next dose level will not proceed.

A recent meta-analysis of 13 randomised controlled trials involving 1910 patients has shown that the application of a bundle of care, as part of the enhanced recovery after surgery (ERAS), relative to standard surgical care, results in a significant decrease in the length of hospital stay and overall complication rates (Zhuang et al. 2013). Apart from associated benefits to the patient in terms of quicker return of normal function and less complication rates, there are significant economic implications as well. Current practice at The Northern Hospital is to provide ERAS to all surgical patients undergoing colorectal surgery. The provision of deep neuromuscular blockade, relative to standard neuromuscular blockade has been shown to improve surgical conditions in laparoscopic surgery (Blobner, et al. 2015; Madsen et al. 2015) and to decrease post-operative pain (Hua et al. 2014). To date, no trials have been conducted to determine whether the use of deep neuromuscular blockade to patients having laparoscopic colorectal surgery and being managed with the ERAS bundle of care, leads to further improvements in patient outcomes, in particular, quicker return of bowel function and reduced length of hospital stay. In addition, it is likely that deep neuromuscular blockade for the duration of surgery will minimise the possibility of trauma to surrounding tissues and reduce surgical operating time, with its associated economic implications.

This is the 2nd human trial in gerilimzumab testing the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of gerilimzumab. A single dose of 5 mg gerilimzumab or 20 mg gerilimzumab or placebo is administered at three 4-weekly intervals (D1, 28, 56). Participants are followed through to D84. This is a randomized, double-blind, placebo-controlled, multiple dose study.

Low plasma vitamin C and E have been more likely to be found in demented patients than in healthy controls. This is supported by findings from a prospective cohort study from Department of Health/Medical Research Council Nutritional Programme in which participants (n = 921; greater than or equal to 65 years) with the lowest Vitamin C status displayed the poorest cognitive function, a finding which persisted when corrected for age, illness, social class, or other dietary variables. Additionally, a recent an epidemiological prospective cohort study showed that high dietary intake of vitamin C and vitamin E may lower the risk of Alzheimer disease. Higher vitamin C blood levels have been found in association with a better memory performance among subjects older than 65 years. Studies have shown that blood vitamin C concentration falls during acute phase responses such as after surgery, trauma, sepsis, and burns. Researchers at the University of Toronto have shown that anaesthetics following surgery can cause long-term memory loss. In a recent study, blood concentration of vitamin C decreased post-operatively and the reduction was significant 7 days after coronary heart surgery. A study is yet to correlate paper and pen assessments such as the Mini mental State Examination (MMSE), Hopkins Verbal Learning test (HVLT-R) and symbol digit modalities test (SDMT) with a computer based cognitive testing such as the SUCCAB. The SUCCAB assesses accuracy and speed, which have been shown to correlate to cognitive decline through ageing. There is consensus that crystallised abilities (vocabulary and general knowledge) can remain stable until very late in life whereas fluid abilities (attention, executive function and memory) decline from middle adulthood until late age. The cognitive tests incorporated in the present study will primarily examine these fluid abilities. The MMSE assesses cognitive impairments in clinical and research settings. The HVLT-R is a reliable neuropsychological test of many aspects of verbal learning and memory, requiring subjects to recall as many items as possible from a list of common words. The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. Previous research measuring vitamin C has incorporated simple food questionnaires to predict vitamin C levels. The proposed study will measure serum vitamin C levels thoroughly through a means of ELISA testing. The proposed project aims to examine vitamin C serum concentration and cognitive performance measured by SUCCAB, and the pen and paper tests, including the MMSE, SDMT, and HVLT-R.