ANZCTR search results

Peripherally inserted central catheters (PICCs) were developed to provide short to medium term vascular access for patients requiring the infusion of vessel irritant medications, or frequent blood sampling. While PICC’s provide necessary, reliable and accessible vascular access; they are associated with biological, mechanical or infectious complication. These complications result in delayed treatment, need for reinsertion, and delayed treatment of the underlying complication - causing extended admission time, increased healthcare costs, venous depletion and increased morbidity and mortality. Microbial biofilm formation makes treatment of infections more complicated since the detached microbial cells from the biofilm can repeatedly infect the blood, and these microorganisms are highly resistant to many antimicrobial agents, frequently requiring PICC removal and antibiotic treatment. Maintaining catheter function is vital for the safe provision of treatment. BioFlo (trademark) PICC (by Angiondynamics; NY) claims to provide a novel solution and the manufacturers claim the material is resistant to blood products and biofilm development, reducing the risk of standard PICC complications including infection, fracture, thrombosis, leakage, localised swelling, accidental removal and dislodgement . These PICCs are now on the basis of some clinician preference at some Australian facilities. The effectiveness of this product at reducing PICC-associated complications as previously described has not been undertaken. We plan to undertake a randomized controlled trial at the RBWH. Patients who consent to participate in the trial will be randomly assigned to either study group. The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of this new PICC technology compared to older generation PICC relating to failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for adults with PICC in acute care.

Background: Administration of corticosteroids prior to birth is of clear benefit to the preterm neonate, with reductions in respiratory, neurological, gastrointestinal, and infectious morbidity, as well as decreased mortality. This benefit was previously proven to exist up to 34 weeks’ gestation but has recently been demonstrated to apply to all neonates born prior to 37 weeks. This benefit is not achieved without potential complications, however, including hyperglycaemia and ketoacidosis in diabetic mothers and neonatal hypoglycaemia. Direct fetal administration of corticosteroids, by ultrasound-guided intramuscular injection may provide the neonatal benefits of steroids while avoiding the maternal and neonatal complications. Objectives: This pilot study aims to assess the feasibility of a larger randomised controlled trial of direct fetal administration versus maternal administration of corticosteroids with the following objectives: a. To assess the effects of directly administered fetal corticosteroids upon maternal glucose homeostasis (hyperglycaemia and ketoacidosis). b. To demonstrate that direct administration of fetal corticosteroids is not associated with adverse fetal/neonatal outcomes including excess preterm birth or neurovascular injuries Trial plan: This pilot randomised controlled trial will recruit 20 pregnant women with pregestational type 1 or type 2 diabetes who are planned for delivery between 34+0 and 36+6 weeks’ gestation and therefore candidates for antenatal corticosteroid administration. Consenting women will be randomised to receive either standard maternal administration of two doses of betamethasone or direct fetal intramuscular injection of a single dose of betamethasone. The primary outcome will be the rate of hyperglycaemia or ketoacidodis requiring treatment. Secondary outcomes will include neonatal rates of respiratory morbidity, hypoglycaemia, and sepsis, and maternal infectious morbidity.

Detrusor hyperactivity with impaired contractility (DHIC) is a common clinical entity that is poorly understood, under-recognized, and difficult to effectively manage. It is a condition in which patients unexpectedly display detrusor overactivity (DO) during storage, yet are unable to mount a sufficient detrusor contraction during voiding to completely empty the bladder. It was first described by Resnick in 1987, as the second most common cause of urinary incontinence in institutionalized elderly people. Although initially described in frail institutionalized elderly, DHIC has been increasingly recognized as a cause of lower urinary tract symptoms (LUTS) in elderly patients . DHIC was identified as the principal dysfunction in up to 8-18% of elderly patients referred for urodynamic studies, furthermore DHIC was more commonly seen in men. There is no defined treatment algorithm for patients with DHIC, but typically, patients have been treated based on the severity of their particular symptoms. Sacral neuromodulation (SNM) is currently approved as a treatment for both idiopathic DO, and non-obstructive urinary retention independently. It is theorised that SNM would potentially treat both aspects of DHIC, the DO and poorly contractile bladder. Currently, there are no studies evaluating the efficacy of SNM for DHIC. In this study, we aim to evaluate the efficacy of SNM for treating DHIC.

The aim of this research is to test the impact of micronutrient enhance or micronutrient + milk lipid enhanced milk beverages on cognitive function in primary school aged children. The intervention products have been formulated on the basis of growing research suggesting a beneficial role of milk lipids for supporting brain health and, by extension, cognitive function. As part of this study, children aged between 7 and 9-years + 4-months at trial commencement will be randomly allocated to an active intervention arm (micronutrient enhanced OR micronutrient + milk lipid enhanced) or placebo arm (standard milk). Participants will consume two 150ml serves of the study product daily for 24 weeks. On the basis of previous research results on both micronutrient and milk lipids, the following hypotheses are made: 1) Consumption of two serves of micronutrient + milk lipid enhance beverages daily for six months will lead to improved cognitive function compared to micronutrient and control groups. 2) Consumption of two serves of micronutrient enhanced beverages daily for six months will lead to improved cognitive function compared to the control group.

The Signposts for Building Better Behaviour program is a manualised parenting intervention, initially developed to assist parents in managing difficult behaviour seen in children with an Intellectual Disability. More recently, research suggests efficacy when used with the parents of children with an Acquired Brain Injury, where challenging behaviours are a reasonably common and persisting long-term sequelae of the injury. The current study is investigating the feasibility, consumer satisfaction, and preliminary efficacy of delivering the program with online clinician support, via videoconferencing. We hope that delivery through this medium may improve program access for families, where barriers such as living in rural areas or working full time would have prevented them from participating in the face-to-face format that is usually offered through rehabilitation services. It is expected that the program will have a high level of parent satisfaction, when delivered with this mode of clinician support. It is also expected that relative to those who received treatment as usual, those who completed 'Signposts' will report: 1. Lower levels of child behaviour problems, both internalising and externalising 2. Lower levels of parental distress 3. Lower levels of dysfunctional parenting 4. Higher levels of family functioning 5. Higher levels of satisfaction in the parenting role. Further, it is predicted that these effects will be maintained post-intervention, with no significant increases in behaviour problems, parental distress or dysfunction, and no significant decreases in family functioning or parent role satisfaction, reported at 4-month post-intervention follow-up.

This research is aiming to test an intervention led by the practice nurse in general practice to calculate and discuss people's individual risk of bowel cancer and screening tests in order to have risk appropriate screening to detect a malignancy or pre-malignancy as early as possible. Who is it for? Any primary care patient aged between 50 and 74 years who has an appointment with a general practitioner (GP) who is participating in the study. Anyone who has had a previous colorectal cancer diagnosis will not be eligible. Study details: Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will continue to receive the usual care in the primary care clinic. Participants in the other group will go through a web-based colorectal cancer risk assessment with the research nurse, who will then provide risk output and screening advice which can be discussed with their GP. Our primary aim is to determine well the risk assessment tool encourages patients to have and doctors to recommend colorectal cancer screening that is appropriate for the patient’s actual risk of developing the disease. The research is part of a larger body of research: the 'NHMRC Centre for Research Excellence for Reducing the Burden of Colorectal Cancer by Optimising Screening: Evidence to Clinical Practice'.

Sporting injuries cost the Australian community approximately $1.65 billion annually and are the most common form of injury sustained by adolescent individuals. Severe sporting injuries can have serious health repercussions for young people and lead to the development of osteoarthritis and low back pain (LBP) later in life. Injury in the adolescent years may also discourage future sports participation and lead to physical inactivity, a major risk factor for the development of coronary heart disease, type 2 diabetes and various forms of cancer. Sporting injuries can also increase the risk of future sports-related injury, decrease individual/team performance and negatively impact psychology. In the sport of cricket, fast bowlers sustain the most injuries, some of which can be severe and result in a large loss of playing time. Various risk factors for injury have been identified in cricket pace bowlers however, limited research has attempted to examine if these risk factors can be modified. This study will therefore attempt to employ an exercise-based intervention to modify known risk factors for injury in cricket pace bowlers. Hypothesis: It is hypothesised that the exercised-based injury prevention program utilised in this study will successfully modify a range of risk factors for injury in adolescent pace bowlers. The control group may show pre/post-test changes however, these changes are expected to be significantly smaller to those seen in the intervention group

Ketamine is an induction agent to induce general anaesthesia in the emergency department, associated with less frequent episodes of hypotension than other agents such as thiopentone1 or propofol2. However, it is typically associated with increases in blood pressure in stable patients, and can cause hypotension in shocked patients3. In critically ill patients, avoiding hypotension is important, as it’s occurrence is known to be associated with poor outcomes4, particularly in the head injured patient5. However, hypertension is also associated with poorer outcomes, particularly in patients with intracranial bleeds (although cause and effect is not established) 6, and is usually avoided in haemorrhagic shock, due to consensus concern about increasing bleeding7,8. Co-administration of fentanyl during rapid sequence induction has been advocated as leading to less deviation from baseline haemodynamics9. It remains unclear whether in the emergency department and pre-hospital setting, this has any significant impact on mortality, and this exploratory study aims to evaluate whether patients undergoing RSI with ketamine and fentanyl, rather then ketamine and placebo have fewer episodes of adverse haemodynamic effects (systolic blood pressure less to 91 mmHg or greater than 149 mmHg) within the first 10 minutes following induction, and whether there is a subsequent difference in mortality at 3, 7 and 30 days. The study will be powered to detect a difference in the percentage of patients who meet the primary endpoint of low or high blood pressure, and will be used to inform future work regarding difference in mortality benefit. 1. White PF. Comparative evaluation of intravenous agents for rapid sequence induction –thiopental, ketamine and midazolam. Anaethesiology, Oct 1982; 57(4): 279-84 2. Hug CC Jr et al. Haemodynamic effects of propofol: Data from over 25,000 patients. Anaethesia and Analgesia, 1993; 77 (4 suppl):S21-9. 3. Miller M et al. The haemodynamic response following ketamine induction for pre-hospital anaesthesia in shocked and non-shocked patients. Ann Emerg Med, 2016 April; 4. Hefner AC et al. The frequency and significance of post-intubation hypotension during emergency airway management. J Crit Care. 2012 Aug; 27(4):417, e9-13. 5. Manly G, et al. Hypotension, hypoxia and head injury: Frequency, duration and consequences. Archiv Surg. 2001 Oct; 136(10):1118-23. 6. Honner SK et al. Emergency department control of blood pressure in intracerebral haemorrhage. J Emerg Med. 2011; 414(4): 355-61. 7. Bickell WH, Wall MJ Jr, Pepe PE, Martin RR, Ginger VF, Allen MK, Mattox KL. Immediate versus delayed fluid resuscitation for hypotensive patients with penetrating torso injuries. N Engl J Med. 1994 Oct 27;331(17):1105-9. 8. Dutton RP, Mackenzie CF, Scalea TM. Hypotensive resuscitation during active hemorrhage: impact on in-hospital mortality. J Trauma. 2002 Jun;52(6):1141-6. 9. Lyon RM et al. Significant modification of traditional r

This pilot study will investigate the feasibility of implementing a multidisciplinary pre-operative very low calorie (VLCD) weight loss program in adult obese patients awaiting general elective surgery. This study will initially enrol a pilot sample of 50 patients who have a Body mass Index (BMI) equal to or over 30kg/m2 who attend the Pre-admission clinic for elective general surgery at The Prince Charles Hospital. Participants will be randomised into a control group or an intervention group. Participants in the intervention group will follow an 8 week very low calorie diet that incorporates Optifast meal replacement shakes. Participants randomised to the control group will receive standard care that includes a generic weight loss information pack provided by the clinic nurse. Measures to assess health related quality of life, body composition and adherence to the program will be collected. Unfavourable surgical outcomes will be measured until 30 days post elective surgery.

Major depression affects one in 16 young Australians. The first line of pharmacological treatment for severe depressive disorders in young people is selective serotonin reuptake inhibitors (SSRI). However, beneficial clinical effects are rarely observed before 4-8 weeks, whilst negative side effects (e.g., increased activity leading to increased suicide risk) are present. Consequently, a major question is whether there is a treatment strategy that could alleviate depressive symptoms in the initial 4-8 weeks? Recent data showed that a single dose of nitrous oxide (N2O) in adults with severe depression had significant antidepressant effects, and maximum effects were observed 24 hours after administration. However, no studies using N2O in minors have been conducted. The proposed research aims to investigate whether N2O has the same antidepressant effects in minors by using a between-group single-blind design. Participants will be randomly allocated to treatment (N2O) or placebo, and monitored weekly up to 12 weeks after treatment initiation. We expect that an average improvement in mood will be observed for the group allocated to the nitrous oxide condition.