ANZCTR search results

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

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32898 results sorted by trial registration date.
  • Augmented Renal Clearance in The Intensive Care Unit - A Multicenter Study

    The kidneys have a range of essential functions in the body. Central to their role in the excretion of waste products and pharmaceuticals is the filtration of plasma (the non-cellular component of blood). During this process, substances (such as glucose, amino acids, electrolytes, waste products and some drugs) leave the circulation and enter the renal tubule. Subsequently, drugs / metabolites can be added to or reabsorbed from the filtrate as it passes along the tubule prior to excretion in the urine. In this manner the kidney is responsible for the elimination of a wide range of drugs and toxins. The rate at which plasma is filtered by the kidneys is referred to as the glomerular filtration rate (GFR) and is largely determined by renal blood blow (RBF). Ideal filtration markers (substances that are only filtered and neither secreted nor reabsorbed by the kidneys) are used to accurately measure GFR (eg Sinistrin), although are not routinely available in a clinical setting. Creatinine is a small molecular weight amino acid derivative that is freely filtered and secreted (10%) by the kidneys. A clinically useful measure of GFR involves calculating a timed creatinine clearance, which reflects the rate at which plasma is cleared of creatinine over a given period of time. Although research has largely focused on patients with declining renal function, there has been little attention on those with augmented renal clearances (ARC). We believe this phenomenon is likely to be common in patients on admission to the intensive care unit, and to date, has been largely under appreciated, although the implications are significant. For example, more rapid excretion of antibiotics may result in sub therapeutic levels, treatment failure or the selection of resistant micro-organisms. These complications in turn could significantly impact on morbidity and mortality associated with the patients ICU stay. This study will investigate this phenomenon in a population considered “at risk”, and define the role of commonly employed therapeutic inventions in promoting augmented clearances. This research will lead to further prospective work on tailoring dosage regimens in patients admitted to the ICU.

  • Evaluation of the effects of oral nutrients on gastric emptying, small intestinal transit, gastrointestinal hormones and appetite in humans

    To investigate the hypothesis that in overweight and obese subjects, oral ingestion of nutrients will be associated with attenuated slowing of gastric emptying and suppression of appetite and energy intake, when compared with lean subjects

  • High- versus low-energy density preloads in overweight/obese men: acute effects on gastric emptying, gut hormone release and energy expenditure

    The primary aims are to determine: i) the acute effect of manipulating the energy density of a meal by increasing its fat content, on subsequent energy intake at lunch, in obese men. ii) whether the effect of energy density is related to changes in mediators of energy intake including gastric emptying, gut hormone release, postprandial thermogenesis and appetite sensations.

  • Evaluation of the Choose Health Program: A Healthy Lifestyle Program for Overweight and Obese Adolescents.

    This study explored the efficacy of the Choose Health Program, a cognitive behavioural lifestyle program for overweight and obese adolescents. The program aims to increase participant's knowledge and skills so they are better able to make healthy lifestyle choices. It was delivered by a psychologist and conducted with individual families with adolescents and their parents attending sessions together. It was predicted that participation in the program would result in improved body composition and cardiovascular fitness, healthier eating and physical activity behaviours, and improved psychosocial wellbeing.

  • Ultrasound-guided non-targeted liver biopsies: complication rates of single versus multiple pass techniques

    Liver biopsy procedures are conducted using either a ‘single pass’ or ‘multiple pass’ method whereby a needle is inserted into the patient to extract liver material once (single pass) or more than once (multiple pass). The type of procedure used depends on the practitioner’s preference as there is a need to strike a balance between ensuring extraction of a sufficient tissue sample and the comfort / safety of the patient. The aim of this project will be to compare the complication rate of single versus multiple pass techniques in ultrasound-guided non-targeted liver biopsies. It will be a randomised, prospective trial in which patients will enter one of two groups. The first group of patients will have a single 14gauge(g) non-targeted ultrasound-guided liver biopsy. The second group will have two 14g non-targeted ultrasound-guided liver biopsies using a foam plug for haemostasis. Due to the interventional nature of liver biopsies, the clinicians and patients are unable to be blinded. All patients will continue to have an International Normalised Ratio (INR) prior to their procedure (current practice). Consent for the procedure will be obtained along with consent to participate in the trial. Patients will be assessed for pain in the recovery period using a visual pain scale and clinicians will be required to document peri/procedural complications. The reporting pathologist will be required to comment on the diagnostic yield and quality of the biopsy sample. These additional data collection steps will be included in an addendum to current liver biopsy clinical pathway. The rationale for comparing these two groups is to reflect clinical practice as these two techniques are used by different interventional radiologists at RBWH and to establish whether one technique should be adopted universally within the department. The results will review safety, patient tolerability, yield, clinical indication, and coagulation status with an emphasis on complications including pain.

  • Mailed feedback for at-risk drinkers presenting to rural emergency departments

    This study aims to evaluate whether mailing personalised feedback to problem drinking patients from rural emergency departments reduces their alcohol consumption, experience of alcohol-related harm, and/or repeat use of emergency departments.

  • A population-based comprehensive lifestyle intervention to promote healthy weight and physical activity in people with cardiac disease

    Cardiovascular disease (CVD) is the leading cause of death and the most expensive group of diseases treated in Australia. Maintaining a healthy weight and engaging in regular physical activity are important behaviours for the primary and secondary prevention of CVD. However, many people with CVD are overweight and insufficiently active. In addition, only 20 to 30 per cent of people requiring secondary prevention services for CVD attend traditional centre based cardiac rehabilitation (CR) groups. To improve outcomes of and access to CR services there is a need for the efficacy, effectiveness and cost-effectiveness of alternative approaches to CR to be established. This randomised control trial aims to: 1. Determine the efficacy of a telephone-delivered comprehensive lifestyle intervention on weight and physical activity in people with CVD in urban and rural settings. 2. Determine if the findings on physical activity reported by Butler et al (2009) and Furber et al (in press) are replicated in the control group of this trial. 3. Determine the costs and cost-effectiveness of the comprehensive lifestyle intervention in urban and rural settings, compared to outcomes achieved. 4. Explore the perceptions of cardiac rehabilitation staff and trial participants in rural and urban areas regarding usefulness and acceptability of the comprehensive lifestyle intervention to promote physical activity and healthy weight for people with CVD. This trial addresses a significant gap in public health practice by providing evidence of the efficacy and cost-effectiveness of a low cost, low contact, high reach intervention promoting healthy weight and physical activity among people with CVD in rural and urban areas in Australia. If effective, this population-based approach has the potential to cut health costs and improve access to secondary prevention programs, particularly for rural and disadvantaged communities. References Furber S, Butler L, Phongsavan P, Mark A, Bauman A. Randomised controlled trial of a pedometer-based telephone intervention to increase physical activity among cardiac patients not attending cardiac rehabilitation Patient Education and Counseling. Published online Dec 16th 2009. Butler L, Furber S, Phongsavan P, Mark A, Bauman A. Effects of a pedometer based intervention on physical activity levels after cardiac rehabilitation: A randomised controlled trial. Journal of Cardiopulmonary Rehabilitation and Prevention 29(2):105-114 (2009).

  • Ultrasound-guided axillary vein approach to the subclavian vein versus traditional infraclavicular subclavian vein cannulation for central venous access: a prospective randomised pilot study in intensive care patients

    To assess whether ultrasound-guided axillary vein cannulation is more successful, less difficult and has fewer complications than landmark-guided infraclavicular subclavian vein cannulation for central venous access (CVA) in the intensive care unit. The hypothesis is that ultrasound-guided axillary vein cannulation is more successful, less difficult and has less complications than the traditional infraclavicular approach

  • A randomised controlled trial of three forms of psychosocial early intervention for borderline personality disorder in youth.

    Borderline Personality Disorder (BPD) is a severe mental disorder that arises during adolescence and young adulthood. This study investigates the most effective form of early intervention for young people (15-25 years old) presenting for treatment of BPD for the first time. It is a randomised controlled trial comparing three interventions: two forms of the specialised HYPE early intervention (one with and one without 16 sessions of individual Cognitive Analytic Therapy), along with an intervention of the same duration comprising general youth mental health care. The primary outcomes are improvement in interpersonal problems and social adjustment. It is expected that at the 12- and 18-month time points after enrolment that participants who receive HYPE plus individual Cognitive Analytic Therapy will have better outcomes on these measures than those who receive HYPE without individual Cognitive Analytic Therapy, and that both these groups will have better outcomes than those who receive general youth mental health care.

  • Epidural vs Tranversus abdominis plane (TAP) Catheter for pain relief in Abdominal Surgery

    Epidural analgesia is considered to be the golden standard for postoperative analgesia after abdominal surgery. However, rare but serious central neuraxial events have been reported. In recent years transversus abdominis plane (TAP) block has been used to obtain postoperative analgesia after abdominal surgery. This peripheral nerve blocking technique is not associated with the central neuraxis complications described with epidural analgesia. The technique is easy to perform blindly or under ultrasound guidance and can be used when an epidural technique is contraindicated. Postoperative monitoring for TAP block has a lower complexity level compared to epidural analgesia. Although TAP block has been shown to be effective, no studies have been published comparing continuous TAP block with epidural analgesia. The aim of this study is to compare Epidural Catheter Technique vs. Transversus Abdominis Plane (TAP) Catheter Technique for Abdominal Surgery in regards to technical difficulty, analgesic efficacy, and patient satisfaction.

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