ANZCTR search results

Adequate thiamine is an essential co-factor to utilise glucose. There is biological plausibility that phosphate deficiency may identify a cohort at greater risk of thiamine deficiency, and that these deficiencies are synergistic. However, currently, critically ill enterally-fed patients with hypophosphatemia do not receive pharmacological administration of thiamine. Data from the use of thiamine in a wide range of settings suggest that the dose regimen to be evaluated in this trial is tolerable and safe, and this is consistent with the Australian Register of Therapeutic Goods listing of thiamine. However, to the best of our knowledge, there are no studies in the ICU population to evaluate whether pharmacological administration of thiamine to this cohort of patients provides biological, physiological, or even clinical advantages. This multi-site randomised, controlled trial will test whether the intervention (thiamine) administered to patients with hypophosphatemia significantly reduces the primary outcome, blood lactate, which is a robust marker of clinical outcome.

This study aims to determine whether steroid (medication) delivered directly through an intravenous cannula before cochlear implant operation will better protect ear function during and after the operation.

A total of 40 children (aged between 6 months and 9 years of age) will be enrolled into this research study. After written and informed parental consent, a 3ml blood sample will be collected to determine the baseline anti-haemagglutination antibody titre. The participant will then be administered the Southern Hemisphere Licensed Quadrivalent Seasonal Influenza vaccine according to the Australian Immunisation Handbook (AIH) guidlines. At the last visit, a second 3ml blood sample will be collected for the determination of post-vaccination antibody titres.

To determine whether adding kappa carrageenan to over-the-counter sinus rinse Flo Sinus Care can hasten the recovery after surgery when compared to the product alone. 50 participants will be recruited from The Queen Elizabeth Hospital who require endoscopic sinus surgery to treat chronic rhinosinusitis. Their randomised blinded treatment will be either Flo Sinus Care or Flo Kappa sachets for reconstitution and delivered as a sinus rinse for 12 weeks following surgery. We will assess each patient at time of surgery, 2 weeks, 6-8 weeks, and 3 months post-surgery using endoscopic scores and symptom scores, as well as an. intranasal bacterial swab and mucus sample at each time-point to measure inflammatory cytokines. Following on from our in vitro work with the above-mentioned treatments, we expect Flo Kappa to have a positive effect on healing and patient symptoms by way of reduced infection and inflammation.

Emergency surgery is a growing health issue because it is becoming more common and the patients are becoming older and sicker. One month after surgery, one in twenty patients do not survive and one in five patients suffer a major medical issue. One of reasons for this poor outcome is that there is often not enough time for doctor’s to fully evaluate patient’s medical status before emergency surgery. Therefore, the surgery often proceeds without the doctors having a complete medical evaluation of the patient. This can result in errors in treatment and a delay in correct diagnosis, that can result in progression of the disease or harmful treatments. A brief ultrasound examination of the patient has been shown to improve doctor’s medical evaluation of patients before surgery. For example, an ultrasound of the heart may identify a weak heart or blocked valve. In this study we wish to find out whether an ultrasound of the heart, lungs and leg veins results in a better medical outcome and shorter length of hospital stay in patients over 65 years old requiring emergency surgery.

The World Health Organisation (WHO) and Centre for Disease Control (CDC) guidelines recommend liberal provision of oxygen intraoperatively and in the early post-operative period to reduce the risk of post-operative infection. However, evidence from related specialties indicates that overall, liberal oxygen therapy may be increase mortality and non-infection-related complications compared with restricted oxygen therapy raising the possibility that any decreased infection risk might come at the cost of an increased risk of other complications. For adults having major surgery, it is biologically plausible that more restricted use of oxygen therapy than occurs in standard practice might improve patient outcomes; however, it is also biologically plausible that more liberal oxygen therapy might improve patient outcomes compared with standard care. Overall, the optimal approach to oxygen therapy in the setting of major surgery is uncertain. HOT-ROX will be the first trial evaluating restricted oxygen therapy vs. standard care and liberal oxygen therapy vs. standard care in patients having major surgery that is powered to assess the effect of these treatments on days alive and at home at 30 days (DAAH30). DAAH30 is strongly associated with the occurrence of postoperative complications and encapsulates the patient-important effects of such complications because it effectively combines hospital length of stay, readmission episodes, discharge destination and early post-operative mortality into a single outcome measure. The first interim analysis is planned after recruitment of 210 participants and in addition to predefined early stopping criteria will assess the listed feasibility outcomes.

The primary aims of this study are to: 1) Evaluate pain modulation capacity in people with musculoskeletal shoulder pain; and 2) Investigate the effects of pain modulation on treatment outcomes in people with musculoskeletal shoulder pain. Study design: Prospective longitudinal cohort study with 6-month, 12-month, and 24-month follow up Outcome measures will be collected at baseline and at 6, 12, and 24 months follow up. These include: 1) Demographic, condition history information, physical screening (baseline) 2) Pain modulation tests (predictors, therefore only collected at baseline) and psychosocial questionnaires (baseline) 3) The outcomes to determine treatment effect are the Shoulder Pain & Disability Index and the Global Rating of Change (GROC) score, evaluated at baseline (Shoulder Pain & Disability Index only), and 6, 12, and 24 months follow up. Individuals aged 18-75 years who have a referral for treatment of musculoskeletal shoulder pain will be included in this study. Following baseline assessment, patients will undergo usual care for their shoulder pain, and clinical outcomes (global rating of change; pain and disability) will be collected at 6, 12, and 24 months follow up. The type of treatment received will be elicited from participants at follow up and extracted/confirmed from medical records.

The study will be conducted at the CALHN sites comprising The Queen Elizabeth Hospital and Royal Adelaide Hospital with patients who are scheduled for elective laparoscopic colonic surgery. The purpose of this study is to assess the efficacy of wound infiltration over the newer regional analgesic technique called erector spinae block (ESP) block for the postoperative analgesia.Efficiency is assessed by comparing pain scores, analgesics use and other outcomes measures analysed are, discharge time and clinical determinants of adverse effects. We hypothesize; that ultrasound-guided ESP block is superior to surgically guided wound infiltration in providing superior pain relief without major side effects.

The current study will sample healthy older volunteers aged 50-75 years to examine the effects of the Blackmores micronutrient formulation on cognitive function, mood, cardiovascular function and brain function. Research has investigated the individual components of the combination formula but research is yet to examine the effects of this newly devised combination formula on cognitive, cardiovascular and biochemical outcomes. One hundred and twenty participants will be recruited to take part in this trial, to allow for a complete set of 100 participants after attrition. Participants will complete three visits at the site (screening, baseline and 90 days follow-up), as well as three testing sessions completed online in their own home (14 days, 30 days and 60 days post first dose). Forty participants (20 per treatment arm) will also undergo brain imaging procedures at the baseline and follow-up visits. We hypothesize that significant improvement in cognition will occur after 3 months administration of the combination formula relative to placebo. In addition, it is hypothesized that the largest cognitive improvements will be seen at the longest time points (3 months) of administration. Secondary or exploratory outcomes/hypotheses concern the effect of this supplement on the neuroimaging, biochemical and neuropsychological variables.

This is an interventional study investigating the rate of gummy shark (flake) allergy in children with previously diagnosed fish allergy. We aim to recruit 35 patients between the ages of 1 and 18 with fish allergy and challenge them flake in a medically supervised setting. Based on comparable studies with different allergens, we anticipate a rate of 30% tolerance in this group.