ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33673 results sorted by trial registration date.
  • Does increased intensity of occupational therapy improve occupational performance and hand function in people hospitalized with acute upper limb burns?

    It is estimated that approximately 80% of major burns involve one or both hands. Occupational therapists have a major role in providing hand and upper limb orthoses and instigating exercise and functional activities when structures are adequately healed. Although there are agreed occupational therapy treatment approaches for patients with upper limb burns, there has been no research into the optimal dose of therapy. This project aims to compare two different doses of inpatient occupational therapy for inpatients with upper limb/hand burns in terms of the impact on hand function, self care and length of stay. We will do this by creating two separate groups of participants (group allocation is based on admission dates); 1 control group (admitted between 1/9/15 and 31/12/15) who have received usual occupational therapy care, which is approximately one x 30 minute session daily. 2 Intervention group (admitted between 1/2/16 and 31/5/16) will receive usual occupational therapy care, plus an additional 30 minutes of daily therapy. Outcomes achieved will then be compared between groups.

  • Can Enhanced Recovery After Surgery (ERAS) principles be implemented in an Australian healthcare setting to improve patient recovery after total hip replacement (THR)?

    Patients who undergo total hip replacement surgery traditionally have long surgical incisions, routine urinary catheters and wound drain tubes. Anesthesia involves 12 hours of oral restriction before and after surgery, a combination of local anesthetic blocks, spinal anaesthesia and sedation or general anesthesia. After surgery, patients have varying degrees of immobilization to avoid the risk of early hip dislocation and opioid pain relief which results in slow recovery and hospital discharge at day 4-6. Enhanced Recovery After Surgery (ERAS) principles for joint replacement surgery involve patient education, less invasive surgery, reduced fasting, regular oral analgesia and early ambulation. These principles are packaged together in a ‘bundle’ individualised for a particular hospital unit to account for local practices and preferences. Most ERAS programs have shown a remarkable improvement in patient recovery after joint replacement as measured by decreased hospital length of stay, improved mobilisation and patient satisfaction, with no increase in complications. This study aims to implement and evaluate a tailored ERAS program at Epworth HealthCare, a large private hospital with patients undergoing one-sided THR surgery by a single surgeon. Patients enrolled in the study will be evaluated from the time they are seen in the hospital preoperatively to discharge and followed up by a telephone call at 6 weeks. WHODAS 2.0 and QoR-15 questionnaires will assess patients’ return to health. The recovery of this group of patients will be compared to the recovery of a group of patients who underwent THR before the ERAS program was implemented.

  • A Phase Ib study of lenalidomide in combination with imatinib for adult patients with chronic myeloid leukaemia in second molecular remission

    The primary purpose of this study is to assess the safety and tolerability of combining imatinib (Glivec) with lenalidomide (Revlimid) and to determine whether the combination may improve the likelihood of maintaining a treatment-free remission in the future. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, have been diagnosed with chronic myeloid leukaemia for which imatinib has been prescribed. Patients must have previously had a trial cessation of imatinib and needed to go back on treatment. Patients who may be eligible for this study must have been able to re-achieve and maintain at least 12 months of undetectable or very low levels of leukaemia cells after restarting their treatment with imatinib. Study details? All participants enrolled in this study will receive six months combination therapy of a daily oral dose of 10mg lenalidomide in addition to their existing imatinib medication. After six months, patients will then stop taking imatinib and continue to take the lenalidomide alone for another six months. Patients will then stop taking lenalidomide and enter a monitoring period on no medication which lasts up to two and a half years. If at any point a relapse occurs then imatinib will be re-started, or an alternative therapy if required. Patients will then be followed up for a further three years, giving a total study duration of up to six and a half years. Throughout this period, blood samples will be taken at weekly to six monthly intervals. Patient outcomes will be assessed by evaluating blood samples, bone marrow samples and physical examinations to monitor safety of the drug combination and to monitor disease progression. It is hoped that the findings of this study will provide information regarding the safety and efficacy of lenalidomide in combination with imatinib for improving the chance of chronic myeloid leukaemia patients achieving a treatment-free remission.

  • A First In Human study to compare 2 formulations of dexmedetomidine

    This is a first in human study for the DMTS. This study is evaluating a different formulation of dexmedetomidine by determining the bioavailability and pharmacokinetics of dexmedetomidine following a single 3-day application of the DMTS compared with a 24 hour IV infusion of Precedex and assessing the safety and tolerability. This is an open-label, randomized, two-period, cross-over study.

  • CHESS - Curing Hepatitis C: Effect on the Endothelium and cardiovaScular riSk - a pilot single arm trial, assessing the effect of hepatitis C virus (HCV) treatment with 12 weeks of paritaprevir/ritonavir/ombitasvir, dasabuvir +/- ribavirin on endothelial function.

    Hepatitis C virus (HCV) leads to cirrhosis and/or hepatocellular carcinoma in 20-40% of those infected after 30 years. It is unclear whether the remaining 60-80% of those with HCV derive an objective physical health benefit from the treatment and cure of HCV infection. HCV infection appears to be associated with increased cardiovascular risk, however this is controversial, and it is unclear whether the mechanism is through HCV-induced metabolic syndrome and diabetes, or through chronic inflammation and endothelial dysfunction. The aim of this study if to determine feasibility of using RH-PAT to measure change in endothelial function over time during HCV treatment, to refine assumptions and to seek a signal of effect. These data will then be used to determine if a larger multicentre trial is justifiable and to inform its design.

  • Detecting depression in cardiac patients: exploring the implementation of National Heart Foundation recommendations for depression screening in the hospital setting.

    This study is a translational research project that will generate qualitative data to inform changes to clinical practice in a Cardiovascular acute care setting. Aims: 1 To explore the practical aspects of applying a depression screening protocol 2. To conduct behavioural analysis using the COM-B theorectical model to explore capability, opportunity and motivation of staff to change practice.

  • Stress hyperglycaemia and mortality in critical illness

    Hyperglycaemia in hospitalised patients is independently associated with increased morbidity and mortality in a wide range of patient groups, including the critically ill. The association between hyperglycaemia and poor inpatient outcomes is strong in patients without diabetes. However, despite a greater elevation in plasma glucose concentration and poorer prognosis, hyperglycaemia is a weaker predictor of morbidity and mortality in patients with diabetes. A high plasma glucose concentration in a hospitalised patient can occur because of chronic poor diabetes control and be “normal” for that patient, represent a transient physiologic response to an inter­current illness (stress hyperglycaemia), or be a combination of the above. Stress hyperglycaemia arises because of the inflammatory and neuro­hormonal derangements that occur during a major illness. Therefore, stress hyperglycaemia develops in proportion to the severity of an inter­current illness, and an association between hyperglycaemia and adverse patient outcomes will be, at least in part, a reflection of this. However, stress hyperglycaemia may also directly contribute to adverse outcomes by inducing endothelial dysfunction and oxidative stress. The Endocrine Research Unit, Southern Adelaide Diabetes and Endocrine Services recently developed a metric for stress hyperglycaemia. Estimated average glucose concentration was calculated from glycosylated haemoglobin in 2290 patients acutely admitted to Flinders Medical Centre, Adelaide. Relative hyperglycaemia was defined by the stress hyperglycaemia ratio (SHR), calculated by dividing admission glucose by estimated average glucose. Thus, a patient with a SHR of 1.5 has an admission glucose concentration 50% higher than their average glucose over the prior 3 months. Using data gathered from a research primarily focused on validating the use of HbA1c for diagnosis of diabetes mellitus, a multivariable analysis including glucose, SHR and other potential predictors of poor outcome (e.g age, sex, renal function), the odds ratio for in­-hospital death or ICU admission per 0.1 SHR increment was 1.20 (p<0.001). In contrast, the odds ratio per one mmol/L glucose increment was 1.03 (p=0.31). In contrast to glucose, the association between diabetes and SHR was not affected by diabetic status. These data suggest that SHR is a better predictor of adverse outcomes than glucose and that SHR is associated with poor outcomes in patients with and without diabetes. In this study, we will evaluate whether SHR is more strongly associated with in-­hospital mortality in critically ill patients than absolute glucose. If true, this may create a new paradigm whereby patients in ICU are selected for glucose­lowering therapy based on relative, rather than absolute, hyperglycaemia.

  • The impact of Botox on muscle structure and function in children with cerebral palsy

    Botulinum toxin type-A (BoNT-A) is a current standard treatment used to reduce muscle spasticity in children with cerebral palsy (CP). Intramuscular BoNT-A treatment results in temporary chemo-denervation of the injected muscle creating a muscle that is “weakened” for 2-5 months. Clinical trials in ambulant children with spastic type CP to date indicate that intramuscular BoNT-A injections to the calf muscles reduce spasticity and have a moderate influence in improving gait. In the long term, there is some evidence that BoNT-A injection may delay and reduce the requirement for surgery to treat musculoskeletal deformities and, provide modest functional benefits, however BoNT-A does not seem to prevent the development of muscle contracture. Studies of BoNT-A in animal models have shown reduced spasticity and muscle length maintenance however these adaptations occurred with a concomitant deterioration in muscle volume and strength. In humans significant atrophy in muscles of two healthy volunteers as well as a one child with spastic type CP has been reported. Recently, in older children with spastic type CP (not naive to BoNT-A), it was found that the volume of the injected calf muscle remained decreased 5 weeks following intramuscular BoNT-A injection. Furthermore, it has been reported that spastic type CP muscle volume grows at a much slower rate after BoNT-A injections (regardless of injection frequency) compared to typically developing controls. However neither of these recent studies involved a spastic type CP control group, receiving no BoNT-A, and therefore it was not possible to reconcile whether this slower growth rate is due to the BoNT-A injection or the underlying mechanisms that lead to reduced growth in spastic type CP in general. Muscle weakening from BoNT-A appears to be beneficial in the short-term for children with spastic type CP however until we know the precise time-course of changes which occur in muscle in response to BoNT-A in these children, it is difficult to predict the long term effect BoNT-A injections has on strength and subsequent function. This reasoning underpins the concerns expressed in the literature regarding the possible detrimental long-term effects of BoNT-A injections on muscle structure and function. It is proposed that this randomised controlled trial will assess the impact of BoNT-A injections treatment to the calf muscles. The research plan will provide a comprehensive picture of calf muscle growth in young children naive to BoNT-A and following their first treatment.

  • Expert consensus communication for acute stroke treatment

    Background: Despite thrombolytic therapy using intravenous tissue Plasminogen Activator (tPA) being a recommended treatment for appropriately selected ischaemic stroke patients, use of this treatment remains low. tPA is only provided to 7% of ischemic stroke patients within Australia. A number of factors including, risk of haemorrhage, limited time-frame of 4.5 hours from stroke onset in which the treatment can be given, and difficulties obtaining informed consent, may be factors limiting the administration of this therapy. Patients with acute stroke are often mentally and physically unable to discuss treatment options, and the challenge of obtaining informed consent is only exacerbated in situations that require immediate action. In such situations alternative forms of consent must be sought and the treatment decision may become the responsibility of the patient’s next of kin. Little attention has been paid to the decision making process for patients and their families in such situations. Given the need for an immediate treatment decision to be made, clinicians need to convey the potential benefits and risks of tPA treatment in order for family members to provide informed consent. Employment of best practice communication guidelines may aid the decision making process for family members and help clinicians to clearly convey the recommended treatment for ischaemic stroke patients. Aims: The purpose of the study was to compare, using a randomised controlled crossover trial among hospital out-patients, the effect of an expert consensus communication strategy compared to a usual care communication strategy (shown via video) on 1) participant knowledge of stroke treatment; 2) treatment decisions for tPA treatment for a) patients and b) a family member; 3) the acceptability of the communication strategies; and 4) the preferred communication strategy.

  • Cerebral Haemodynamics and Orthostatic Response to Upright position in acute ischaemic Stroke (CHORUS)

    Stroke is the leading cause of adult disability and mortality in Australia, with the incidence set to rise as our population ages. The majority of strokes are ischaemic in nature and occur when a blood vessel to the brain is occluded, either by a clot or narrowing of the artery. Cerebral blood flow in acute ischaemic stroke is highly dynamic, and factors that either impair or promote cerebral blood flow during the acute phase may directly affect the infarct size and associated clinical deficit. Lowering the head of the bed in the early hours of stroke may theoretically assist flow to the ischaemic tissue, conversely, there is growing support for early mobilisation (getting up) after stroke, with a number of large clinical trials underway. Currently there is no consensus and no clinical guidelines on the safety of early upright posture when caring for acute stroke patients. We are therefore evaluating the extent and clinical relevance of orthostatic changes in cerebral blood flow in acute ischaemic stroke during position changes using transcranial Doppler ultrasound (TCD). The proposed study is a prospective, cohort study of patients with confirmed ischemic (due to a clot) stroke admitted within 24-48 hours of stroke onset to Austin Health. TCD examination is routine for people with stroke at Austin Health. It is performed flat (0 degress) of with the head slightly elevated. In this study, in recruited patients we will extend the current standard care TCD protocol to include measurement of cerebral blood flow velocity in 4 new positions: 30 degrees, 70 degrees, 90 degrees sitting (unsupported) and 90 degrees, standing (if possible). The primary outcome in this study is change in mean cerebral blood flow velocity (CBFVmean) in the middle cerebral artery on the affected stroke hemisphere with change in position from 0 degrees to 90 degrees sitting within the first 24-48 hours of stroke. The assessor of this outcome will be blinded to patient and position. This study will determine whether changing position to upright at 24-48 hours post stroke influences blood flow velocity in the affected hemisphere and whether this response modifies over the first week after stroke. A better understanding of orthostatic changes in blood flow may have significant clinical impact by providing a physiologic basis to guidelines on early head of bed elevation, positioning, and mobilisation of patients with acute anterior circulation stroke. The information from this study will therefore help inform practice and provide pilot data for a larger study that will aim to more clearly identify best practice protocols in subgroups of patients with different stroke characteristics and risk of impaired cerebral autoregulation.

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