ANZCTR search results

Preterm babies are born with a patent ductus arteriosus (PDA), a blood vessel which connects major blood vessels of heart (aorta) and lung (pulmonary artery). PDA can be associated with complications in preterm babies. Therefore, we try to close it with medications, like paracetamol. However, we still don’t succeed in closing a PDA in 30-35% babies. It is possible, that the dose, which we currently provide, may not be enough for some babies. It is still unknown how much paracetamol concentration (level) is needed to achieve a PDA closure. The aim of this study is to measure the concentration and develop a pharmacokinetic-pharmacodynamic (PK-PD) model of paracetamol in preterm babies. This study will enable us to find the appropriate target concentration necessary for PDA closure. We will be able to use this information to vary the dose of paracetamol to achieve higher success rate in preterm babies in future.

Occupational therapists use a range of rehabilitative approaches to work towards their patients’ goals, one of which is implementing occupation-based interventions. Occupation-based interventions, involve the therapeutic use of engagement in occupation (or an intended daily activity) to achieve change. Delivering occupation-based interventions in the inpatient rehabilitation setting is often time and resource intensive, and the demand for increasing intensity of rehabilitation services poses additional challenges to both clinicians and the health system. Occupational therapists commonly use group-based interventions alongside individual therapy. There are several potential benefits identified by both clinicians and patients for group-based interventions including building connections with co-participants through shared experiences, peer-based learning, and improving motivation for therapy; there are also clear economic benefits as groups can improve time and cost-effectiveness through being able to see more patients at once, as well as offering the potential for a higher intensity of task practice. This study aims to compare the effectiveness of occupation-based groups to occupation-based interventions delivered individually. Occupation-based interventions should be client-cenetred, individualised, and flexible in nature, with the content, intensity and duration of therapy tailored to each patient and their specific occupational performance goals. Thus, further research is warranted to determine whether occupation-based interventions delivered in a group setting using semi-supervised practice can uphold the client-centred nature of this intervention effectively, compared with individual-based delivery. This research will aim to determine the effectiveness of occupation-based groups in adult inpatient rehabilitation and explore the factors impacting on implementation and outcomes of such interventions. It is hypothesized that an occupation-based group intervention will be more effective in improving occupational performance outcomes in adult inpatient rehabilitation compared to usual care.

Synthetic haemostatic agent at laparoscopic ovarian cystectomy on ovarian reserve in women aged 25 to 40 years: STASIS study Ovarian cysts are a common gynaecological issue facing reproductive age women and the good standard surgical management is laparoscopic (key hole) ovarian cystectomy (removal of cyst). This procedure can associated with bleeding. Traditional methods to stop bleeding can damage the normal ovary (ovarian reserve) and potentially impact future fertility. Hameostatic (blood clotting) agents are commonly used surgical products applied to the ovary after the cyst has been removed to treat bleeding in a way that minimises damage to the normal ovary. Current available products are human or animal derived. Purastat is a similar product but completely synthetic (does not contain human or animal products), used in Gastrointestinal procedures (colonoscopy and gastroscopy) and is effective in reducing complications related to blood loss. We would like to study if applying this product to the ovary after the time of laparoscopy ovarian cystectomy is protective for ovarian reserve and future fertility.

Each year 160,000 critically ill Australians are admitted to an Intensive Care Unit (ICU) to receive life-saving treatments and around-the-clock care. There is concern that sleep disturbances may result in worse outcomes, including confusion, memory impairment, and depression, some of which may persist for months after leaving the ICU. There are numerous barriers to monitoring the quality and quantity of sleep in ICU patients, with the gold-standard technique of polysomnography (PSG) posing substantial technical and logistical challenges. A new, wearable device, the Somfit (Compumedics) that uses a smartphone app and computer analysis to measure sleep may provide a simpler alternative. This study will compare this novel device and automated scoring algorithm to polysomnography (PSG) interpreted by a trained sleep technologist in adult patients in the ICU.

Pelvic organ prolapse (POP) is a common gynaecological condition with an incidence of 40-60%, and 12-19% of women undergo surgical correction. Standard technique of native tissue repair (NTR) relying on damaged tissue is associated with variable success and recurrence rate up to 30-50% initiating the exploration of innovative surgical techniques and grafts to improve long-term outcomes. Surgery is preferential for younger women with more severe symptoms related to quality of life, if also affecting bladder, bowel, and sexual function. Use of transvaginal polypropylene mesh is no longer accepted in most of the global market due to unfavourable complications of increased reoperation rates, mesh erosion, dyspareunia, and chronic pelvic pain. Surgical techniques using biological grafts or absorbable mesh to augment POP have been trialled, with systematic reviews based on low quality evidence demonstrating minimal advantage compared with NTR regarding rates of awareness of prolapse or reoperation. Low to moderate quality evidence suggests higher recurrence rates for anterior prolapse after NTR than with biological grafts. This is a randomised controlled trial comparing two surgical approaches for pelvic organ prolapse treatment: Intervention Group with autologous graft augmentation and Control Group with conventional prolapse repair surgery. In Group 1, patients undergo native tissue repair surgery for vaginal prolapse, with an autologous graft prepared from 40mls of the patient's own blood during surgery. The graft is then sutured or glued to the underlying connective tissue. In Group 2, patients undergo the same surgery as Group 1 but without the creation of a graft. Postoperative care is identical for both groups, including routine instructions on physical activity, bowel habits, and abstinence from intercourse for six weeks. Patients are followed up teleconsult at one week and face-to-face at 6 weeks, 6 months, and 12 months. Participants are invited to the study after being diagnosed with pelvic organ prolapse that requires pelvic floor repair surgery, having tried medications and non-surgical alternatives with persistent symptoms. The study includes an initial assessment consultation, surgery, and three follow-up assessments at 6 weeks, 6 months, and 12 months after the treatment. No medical expenses are incurred during these consultations or treatments, and both specialists involved in patient care will be responsible for administering the study treatment and performing the assessments. The assessment consultations involve evaluating the pelvic organ prolapse, bowel, bladder, and sexual function to determine the treatment's effectiveness. This study aims to provide valuable insights into the efficacy of autologous graft augmentation compared to conventional prolapse repair surgery, contributing to improved treatment options for patients suffering from pelvic organ prolapse.

This is a phase I, feasibility, prospective, multi-centre, double-blinded randomised placebo-controlled trial in ICU patients with septic shock to test whether the intravenous administration of mega-dose sodium ascorbate is safe and feasible, shortens the time to weaning from vasopressor support and leads to an improvement in biomarkers of sepsis compared to placebo. The study hypothesis is that the mega-dose sodium ascorbate in early septic shock will be safe and feasible.

This study aims to investigate the maintenance or de-training effect of the participants following discharge from the RHM CTS balance programs. It also aims to identify whether or not patients are continuing with physical activity behaviours following discharge and if this has a difference on de-training effects. We hypothesize that the patients who do continue with regular physical activity will have less of a de-training effect then those who do not continue to be active. We hope to identify how we might better encourage a higher rate of continued physical activity.

Peer Workers have lived experience of mental ill-health and are intentionally employed to support individuals with mental ill-health as well as their family and carers. These Peer Workers are inaccessible to many in need, especially for those whose main or only support is through general practice. Our aim is to trial the implementation of a co-designed lived experience peer support intervention for mental health consumers in primary care.

Research has revealed that 50% - 60% of individuals do not seek help prior to a suicide attempt, thus it is imperative we find new ways to reach them. One way to reach them is to use a Google Ads campaign, in which a person visiting the website is asked if they have previously sought help before, with the intention of providing more relevant offerings. In this study, we assess the impact of reducing the effort needed by individuals to seek help on help seeking.

Heart failure with preserved ejection fraction (HFpEF) is the most prevalent phenotype of heart failure. However, the treatment options for these patients remain limited. Permanent pacemakers are commonly used in the management of bradycardia (low heart rate), with many pacemaker patients also presenting with early HFpEF. This study is a prospective, two-arm randomised controlled trial including 160 participants with pacemakers and early HFpEF from Adelaide, South Australia. Participants will be randomised to an accelerated pacing rate (75bpm) or usual care (60bpm), performing follow-up at 4-weeks and 52-weeks post randomisation. It is hypothesised that increasing the heart rate settings compared to standard permanent pacemaker settings, will improve exercise tolerance, defined using peak oxygen consumption, at 12-months post-randomisation.