ANZCTR search results

Increased intestinal permeability, often referred to as ‘leaky gut’, is a measure of integrity and functioning of the mucosal (innermost) lining of the gastrointestinal tract. Increased levels have been found to correlate with the development of sepsis in the Intensive Care Unit. The location of increased intestinal permeability (gastroduodenal, small bowel and whole gut permeability) has not been adequately explored in the Intensive Care Unit. The aim of the study is to determine the location and degree of changes in intestinal permeability in mechanically ventilated critically ill adult patients. Additionally, this study aims to investigate the association between intestinal permeability, inflammation and clinical outcomes. Findings will be compared to data from healthy subjects being recruited in a separate study at La Trobe University (Request ID: 371028).

Abnormal scar development following burn injury can cause substantial physical and psychological distress to children and their families. Common burn scar management techniques include silicone therapy, pressure garment therapy, or a combination of both. Currently no definitive high quality evidence is available for the effectiveness, impact on health-related quality of life, health service costs, adherence and treatment satisfaction of topical silicone gel or pressure garment therapy for the prevention and management of burn scars in the paediatric population. Therefore evidence of the effectiveness of these treatments is required in children. A randomised controlled trial will be conducted. Participants will include 135 children (45 per group) up to 16 years of age who are referred for scar management for a new burn. Children up to 18 years of age will also be recruited following burns scar reconstruction surgery. Participants will be randomised to one of three groups: Strataderm topical silicone gel only, pressure garment therapy only, or combined Strataderm topical silicone gel and pressure garment therapy. Primary outcomes are scar thickness and scar itch intensity. Secondary outcomes include subjective scar severity (e.g. colour, pigmentation, pliability, pain, overall opinion), objective scar colour, health service costs, adherence, health-related quality of life, treatment satisfaction, and adverse effects. Measures will be completed up to 12-months post-burn or post-burn scar reconstruction. Data will be analysed using descriptive, univariate and multivariate statistics including regression analyses. The results of this study will determine the effectiveness of three non-invasive scar prevention interventions in children at risk of scarring post-burn or post-burn scar reconstruction.

The aim of this study is to determine if a course of ketamine is an effective therapy for depression. The study will also determine if repeated ketamine doses: 1) are safe, tolerable and feasible in outpatient settings; 2) provide sustained antidepressant benefits; 3) improve anxiety, suicidal ideation and health related quality of life; 4) are a cost effective treatment. 200 participants will be recruited across 6 sites in Australia (Black Dog Institute, Sydney; Royal Prince Alfred Hospital, Sydney; Monash Alfred Psychiatry Research Centre, Melbourne; South Eastern Private Hospital, Noble Park; Royal Adelaide Hospital, Adelaide; Gold Coast University Hospital, Gold Coast) and 1 in New Zealand (Dunedin, Otago). The study is a randomised controlled trial. Participants will be randomised to receive repeated doses of ketamine or a comparator treatment. For all participants, a follow-up assessment after finishing the randomised controlled phase will assess eligibility for an open label extension phase. All participants will be followed up after exiting the trial to assess treatment effects.

There has never been a more sedentary population than the 21st century western society, with physical inactivity accounting for a similar number of deaths per annum as tobacco. Physical inactivity is a modifiable risk factor for chronic disease, especially cardiovascular diseases, and no other intervention possesses the broad spectrum of health impacts that can be attributed to exercise. However, the cardiovascular response of an individual to exercise is idiosyncratic and, whilst most individuals incur favourable effects, a sizeable proportion (~30%) of individuals either do not respond or respond “adversely” to exercise. The current research study aims to answer two fundamental questions. Firstly, is non-response to one exercise modality universal across all modalities? Secondly, to what extent is non-response to exercise environmentally versus genetically determined?

Chronically transfused patients receive multiple units of blood products over the course of their treatment. Multiple red blood cell (RBC) unit transfusions may lead to adverse transfusion related outcomes including the production of antibodies directed against RBC surface markers (antigens), haemolytic diseases and potential long-term donor cell survival, which is termed ‘microchimerism’. Patients requiring transfusion are routinely typed for ABO and Rh (D) blood group antigens via serological methods since these antigens are immunogenic and its incompatibility with donor RBCs can lead to severe and fatal transfusion outcomes. Patients are also screened for the presence of clinically significant RBC antibodies that are either immunoglobulin (Ig) G or IgM isotypes. Antibodies against RBC antigens are either alloantibodies that are formed in response to foreign RBC antigens acquired during transfusion and pregnancy, or autoantibodies that are directed against an individual’s own RBC antigens observed in patients with haemolytic anaemias and autoimmune disorders. Haemolytic anaemia is a condition where circulating immunoglobulins and/or complement bind to the surface of RBCs leading to their destruction. Direct antiglobulin testing (DAT) is used in clinical investigations to confirm and diagnose the cause of haemolytic anaemia. It detects the presence of IgG or various activated complement components attached to RBC surface membrane when haemolysis or haemolytic anaemia is present. In patients diagnosed with haemolytic anaemia, a ‘pan-reactive’ autoantibody (antibodies indiscriminately reacting with all RBCs) coupled with a positive DAT result can cause difficulty in pre-transfusion testing, since the patient’s serum reacts to multiple donor RBC units. Furthermore, a strongly positive auto agglutinin may mask the presence of concurrent alloantibodies if present. The detection of patient alloantibodies via the auto- and allo- adsorption procedures are prolonged, labour intensive, complex and can often have no clear result. In these situations, a least incompatible but best matched donor RBC unit against the patient’s known phenotype becomes the only option available for transfusion. This project will determine whether the use of RBC genotyping can be a useful integration into routine laboratory transfusion practice in Australia. Information on the patient’s blood group genotype can be used to predict the patient’s blood group phenotype and allow clinical staff managing chronically transfused patients to provide more appropriately matched donor RBC units. The ability to closely match a donor RBC unit to the patient could also prevent several rounds of manual serological laboratory investigations and reduce the risk of alloimmunisation in patients requiring long-term chronic transfusion regimes.

We intend to test the hypothesis that consuming gelatin (a food derivative of collagen) and Vitamin C combined with exercise may increase collagen synthesis. To test this hypothesis, eight healthy males will complete a randomized cross-over design protocol where they will consume either a drink containing a isocaloric placebo, 5, or 15 grams of gelatin at a constant level of Vitamin C. Measurements of amino acid appearance in the blood over the first 3 hours will be measured in each condition and a larger blood draw will be taken at 1 hour to determine the effect of the nutritional supplement on engineered ligament collagen and mechanics. The subjects will perform six minutes of rope-skipping to stimulate collagen synthesis. This short bout of exercise will be repeated every six hours for the next three days and will be preceded by one hour with the appropriate drink containing placebo, 5, or 15 grams of gelatin. Over the 3-day training period, blood will be taken for the analysis of the amino-terminal propeptide of collagen 1 (PINP), a byproduct of collagen synthesis.

Obesity is one of the most prevalent and challenging diseases affecting our community. According to the latest census figures, 63.4% of Australians aged 18 years and over were overweight or obese, namely, 35.0% overweight and 28.3% obese. Along with the increase in our community BMI has been a burgeoning of obesity related diseases including type II diabetes, cardiovascular disease, osteoarthritis, hypertension, liver disease, depression and infertility. Weight loss leads to a significant improvement in these conditions. Currently the only durably effective treatment for the most severe grades of obesity is bariatric surgery. Conservative programs are effective in the short-term, however, only 3% of successful weight losers are able to maintain a meaningful weight loss beyond 2 years. Pre-operative weight loss with a short term very low calorie diet (VLCD) has been shown to improve surgical access by reducing liver volume as well as the metabolic status of the patient, reducing the number of postoperative complications. For this reason, most clinicians request their patients to undertake a preoperative weight loss programme for a minimum of two weeks. Whilst clinicians perceive a benefit for preoperative weight loss, patients often struggle to comply. One reason for this is the difficulty complying with the currently available VLCD. Most are based on liquid formulations and patients struggle with the taste and texture of the product. Patients regularly report bloating, abdominal discomfort and constipation. In addition, the nutritional construct is often based around a large amount of sugar, and lacks high quality protein and fibre. Formulite (Trademark) is a new VLCD that the manufacturers claim retains the benefit of traditional VLCD, inducing Ketosis thereby avoiding hunger, whist reducing the unwanted GI side effects by combining high quality proteins with soluble fibre, less sugar and probiotics. These changes are supposed to improve patient compliance. We wish to confirm potential benefits of Formulite in patients undergoing bariatric surgery. We hypothesised that patient satisfaction would be higher and therefore compliance with the preoperative weight loss programme would be improved when compared with traditional VLCD. HYPOTHESIS: Compliance with Formulite is better than traditional VLCD prior to bariatric surgery in obese adults. AIMS: - To measure patient compliance with Formulite compared to traditional VLCD - To determine if there are improved gastrointestinal symptoms with Formulite compared to traditional VLCD - To assess patient satisfaction with Formulite compared to traditional VLCD - TO measure peri-operative liver volume and weight loss following 2 weeks of Formulite when compared to traditional VLCD

BACKGROUND Patients who undergo major upper gastro-intestinal surgery, such as oesophageal reconstruction or bariatric surgery, have substantially altered stomach and oesophageal anatomy, and therefore both oesophageal transit and gastric emptying are much different. Altered sensations and symptoms, such as reflux, regurgitation and nausea, are sometimes reported by patients. These symptoms are known to be a major determinant of the overall outcome of the procedure and significantly affect patients’ quality of life. Currently, there are few accurate tests able to assess the function of the stomach and oesophagus after major upper gastro-intestinal surgery. Nuclear scintigraphy is a functional test that has considerable utility in the assessment of gastric emptying and oesophageal transit. Observed function can be correlated with outcomes and symptoms. Scintigraphy is well established in assessing symptoms of reflux, swallowing and suspected alterations in gastric emptying. AIMS In this study we aim to establish the normal gastro-intestinal transit function in patients following major upper gastro-intestinal surgery and also correlate the physiology of transit, and emptying with reported levels of reflux, regurgitation and satiety. The aim is to: 1) Establish normative values and determine the expected pattern of oesophageal transit, gastric emptying and small bowel transit following upper gastrointestinal surgery 2) Determine if the patterns of oesophageal transit and gastric emptying and change over time following major upper gastro-intestinal surgery HYPOTHESIS A differing pattern of oesophageal transit, gastric and intestinal transit is observed following upper gastro-intestinal surgery. This patterns changes substantially over the first year following surgery and then stabilises. BRIEF METHODS Patients will be recruited prior to their major upper gastrointestinal surgery (oesophageal or gastric resection, or sleeve gastrectomy). They will undergo 4 nuclear scintigraphy scans after their operations to establish the new function of the reconstructed upper gastrointestinal tract, and correlated these with symptoms, as assessed by validated questionnaires.

In young patients, traumatic injury to the cervical spinal cord generally results from vertebral fracture and dislocation of vertebra, with injury to the spinal cord occurring not just at the time of impact, but also from compression of the spinal cord as a consequence of the displaced vertebra. Traumatic central cord syndrome differs from traumatic SCI in that the general mechanism is hyper-extension of the spine, causing acute severe canal restriction, in a patient with pre-existing narrowing of the cervical canal. Compression of the spinal cord as a result of canal stenosis and cord swelling usually occurs soon after injury. Animal and preliminary human data demonstrate that urgent relief of compression appears to greatly improve outcome. However, urgent decompression in humans is difficult to achieve because of the time occupied by transportation, investigation, and stabilisation of the patient as well as the organisation of surgery. Pre-clinical data demonstrate that hypothermia can suspend the progressive damage caused to the spinal cord by compression thereby allowing decompressive surgery to be performed in a clinically achievable time frame (Batchelor et al. 2010). The primary purpose of the ICED study is to determine whether the combination of hypothermia and early decompression is able to improve outcomes in patients with severe spinal cord injuries of the neck. Selected patients will be cooled by paramedics or emergency physicians immediately following injury and then rapidly transported to theatre to undergo surgical decompression and stabilisation of the spinal cord. Cooling will be maintained for 24 hours and then patients will be slowly rewarmed and monitored over the next 72 hours. The ICED safety and feasibility study will determine whether it is possible to cool patients with spinal cord injuries resulting from vertebral trauma in the neck in the first hours after injury. This study will also determine whether it is feasible to operate on patients very early after injury. As well as determining whether these interventions can be performed, the incidence and severity of complications will be monitored to determine whether these interventions are safe.

This study seeks to determine if incorporating sounds into mindfulness programmes will serve as viable alternatives in enhancing mindfulness skills acquisition, emotional flexibility, and psychological wellbeing, compared to the breath and body, in participants with a history of depression or anxiety. Participants will first be screened in a pre-intervention interview (individually conducted) – using the Structured Clinical Interview for DSM-5 (SCID-5), alongside obtaining demographic information such as age, gender, meditation experience, and music experience. From the SCID-5, any participants with severe presentations will be excluded from the study, but will be provided with referral information as necessary. All participants will be informed about the outcome of the SCID-5, within 1-2 weeks of the interview. Suitable participants will then go through a pre-group session (individually conducted), where they will fill in the Five Facet Mindfulness Questionnaire (FFMQ), Brief Resilience Scale (BRS), and Depression Anxiety Stress Scale-21 (DASS-21). They will also have their heart rate variability taken during the pre-group session. Participants are then randomly allocated (using simple randomisation) to two independent conditions - “active control” (ie. mindfulness activities using the breath and body as attentional targets as per other mindfulness oriented programmes), and “sounds” (mindfulness activities incorporating various sounds as external attentional targets). All participants are blinded to the random allocation process. Following which, participants will attend eight weekly mindfulness sessions, each lasting one hour each (group settings of up to 8 people). Participants in the “active control” condition will first engage in two weeks of mindfulness familiarisation sessions, followed by six weeks of various guided mindfulness activities using the breath and its accompanying bodily sensations as attentional targets. Participants in the “sounds” condition will engage in two weeks of mindfulness familiarisation sessions, followed by six weeks of various guided mindfulness activities accompanied by unique soundtracks lasting 5-8 minutes long. Each soundtrack is only played once throughout the duration of the intervention. During the intervention, regardless of the condition they are in, all participants fill in an Outcome Rating Scale (ORS) at the start of every session; the FFMQ, BRS, DASS-21 and a session rating questionnaire at the end of every session. All participants will also be given session handouts at the end of each session. After the intervention, all participants go through a post-group session (conducted individually), which is identical to that of the pre-group session. Participants will be given opportunities to provide feedback regarding the study, during the post-group session.