ANZCTR search results

Nitric oxide is a chemical released from blood vessel walls and causes vasodilation and low blood pressure known as vasodilatory shock. Vasodilation by this mechanism often occurs in patients who undergo surgeries which need heart lung bypass such as cardiac surgery and can be resistant to normal blood pressure supporting medications. This condition is called vasoplegia. In such patients, methylene blue, which is a common drug that opposes nitric oxide-induced effects on blood vessels may potentially provide a mechanism to reduce the need for blood pressure support in patients having cardiac surgery. Only one previous randomised controlled trial has evaluated the use of methylene blue in patients with post cardiac surgery vasoplegia. A total of 638 patients were screened with 56 who developed post cardiopulmonary vasoplegia included in the trial. Of these, 28 received an infusion of 1.5 mg/kg of methylene blue over 1 hour and 28 received placebo. Mortality was 0% for the methylene blue group and 21.4% in the placebo group. There was also a significant difference in the duration of blood pressure support with all patients in the methylene blue group being successfully weaned from support within 4 hours of the treatment. These results are suggestive of a significant benefit to the routine use of Methylene blue in this group. The objective of the MAGIC trial is to test the hypothesis is that in adults who are invasively mechanically ventilated in the ICU following cardiac surgery with clinically significant vasoplegia who are receiving high doses of blood pressure medications, does a methylene blue infusion at a rate of 1.5mg/kg/hour for one hour increase hours alive and free from blood pressure support at day 10 post randomisation when compared with placebo.

The aim of this study is to understand whether or not treatment with Probucol supports cognitive function in participants with MCI/mild-dementia due to AD. The trial is specifically designed to provide evidence that treatment with Probucol may slow the decline of cognitive ability and functional state. The presence of cognitive impairment will be assessed using neuro-cognitive assessments. Participants will be randomly assigned to one of two groups, group 1 (placebo) or group 2 (treatment). This is a double-blind trial meaning the participant and study doctor will not be aware which group the participant has been randomised to. The study will be 104 weeks in duration (2 years). Participants will be required to take one tablet a day (with food) for the first three weeks, and then two tablets a day (morning and night, with food) for the remainder of the trial. During the screening/pre-baseline phase participants will be asked about their medical history, complete a physical and neurological examination, an Electrocardiogram (ECG), and a blood test. Participants will also complete Neuro-cognitive assessments (memory and thinking tasks), as well as a Magnetic Resonance Imaging (MRI) scan and/or a Positron emission tomography (PET) scan. During the treatment phase, participants will be required to visit the study doctor on 10 separate occasions (once a week for the first 3 weeks, and then at approximately 3 monthly intervals). Each visit will involve a health and safety assessment. Neuro-cognitive assessments will also be conducted at week 26 (6 months), 52 (12 months), and 78 (18 months). A blood sample will also be taken at each visit. At completion of the treatment phase (week 104), participants will recomplete the Neuro-cognitive assessments, MRI and/or PET scan, and provide a final blood sample. During the course of the trial, participants will be required to nominate a 'study partner' (spouse/partner/carer). The study partner will need to attend at least one screening visit. In addition, study partners should make themselves available by phone or preferably in person, to provide information to the study as required. Participants will need to identify a study partner to be eligible to take part in this study.

Cystic Fibrosis (CF) is a chronic, life limiting condition, diagnosed usually at birth and is an autosomal recessive disease. Recent studies have indicated many adults with CF have strong beliefs that exercise may be equal or superior to other traditional forms of airway clearance as the mainstay for treatment. A lack of exercise in a daily regimen for an individual with CF has been associated with increased hospitalisations, poorer health outcomes including decline in lung function and decreased quality of life. There are many barriers to exercise for individuals with CF, some of these being concern over infection control, either using exercise facilities that others with CF may be attending, or other individuals in the general public who may still attend these facilities when they are unwell and increase the risk of cross infection. Beam (www.beamfeelgood.com) is a website that has been developed specifically for individuals with CF, to promote physical activity and movement in a safe setting. This study will review the impact of participating in the exercise sessions available on Beam and participating in a live clinical portal with a treating physiotherapist, to determine if there is an improvement in physical activity and wellness outcomes.

We are conducting a clinical trial to compare the outcomes of two different treatments: i) two telehealth consultations with a physiotherapist (for prescription of home-based strengthening exercises); and ii) two telehealth consultations with a physiotherapist (for prescription of home-based strengthening exercises) plus the subsequent use of a mobile app for 24 weeks. Participants in both groups will receive exercise-based care by a physiotherapist. This will involve two telehealth consultations with a physiotherapist (using Zoom video-conferencing) over two weeks, for prescription of an individualised strengthening exercise program. Participants in both groups will receive resistance bands for exercising. After completing the physiotherapy consultations, participants will be encouraged to continue with their home exercises for the next 24 weeks. Around half of participants will be randomly allocated to download and engage with a mobile app (on their smartphone or tablet) as well, for the 24 week home exercise period. Outcomes will be collected by web-based survey at baseline and 26 weeks after randomisation, with the exception of the two primary outcomes, which will also be measured by web-based survey at 14 weeks after randomisation.

Vasopressor infusions are an essential for management of circulatory shock and are traditionally administered via CVC, though administration via PIVC has also been described. Whether delivery of vasopressor via PIVC is comparable in terms of safety and efficacy to delivery via CVC is currently unknown. We hypothesize that administration of vasopressor medications via PIVC over a short duration, in controlled doses and with appropriate monitoring is safe and effective compared to that via central venous catheter in terms of patient outcomes. This pilot phase 2 study will enroll 40 patients (20 in each group) who are admitted with shock needing vasopressor infusions. Eligible patients will be identified, and once consent is obtained they will be randomized to either an early (short duration of vasopressors via PIVC) or late (longer duration of vasopressors via PIVC) CVC group. The primary endpoints of the study will be feasibility of the protocol and days alive and out of hospital at day 60.

To compare the drug delivery and distribution for inhaled flecainide as compared with the intravenous formulation of the drug with is approved for treatment of atrial fibrillation.

The objective of the study is to assess at whether a bedside Echocardiogram (cardiac ultrasound) improves patient satisfaction of the emergency department performance. Adults with low risk chest pain will be recruited to intervention and control groups. The intervention group will receive a bedside echocardiogram and the outcome measure will be to assess patient satisfaction. An Echocardiogram is not routinely part of the chest pain assessment in ED. The hypothesis of the study is that participants with chest pain who receive an echocardiogram will have higher satisfaction scores compared to those who do not receive an echocardiogram.

Transgender men are treated with testosterone to align their physical appearance with their gender identity and improve mental health. Although the current evidence does show improvements in mental health, there is a lack of high-quality data in this field. We will undertake a pragmatic intervention whereby after initial assessment and informed consent, we will randomise individuals to an immediate testosterone therapy compared to a delayed testosterone therapy group (which due to standard care clinic waiting times is an approximately 3 month wait to commence testosterone therapy). We aim to establish the influence of testosterone therapy on gender dysphoria, depression, suicidality and quality of life in transgender men newly commencing testosterone therapy.

The aim of this study is to investigate the effects of a novel dietary supplement (3DFC) on psychological functioning and other health related outcomes including mood, wellbeing, biochemical parameters, heart rate variability and gut symptoms in adults aged 18-55 years with elevated stress, anxiety and depression symptoms. The 3DFC supplement developed by the principal trial sponsor (Anatara Lifesciences) contains elevated levels of sodium butyrate and is designed to be metabolised by the gut microbiota. The 3FDC supplement has the potential to produce benefits in the outcomes described. The CSIRO will lead a 6-week randomised, double-blind placebo-controlled trial consisting of two intervention arms: 1) the 3DFC dietary supplement; and 2) placebo control. It is expected that the 3FDC supplement will lead to a greater reduction in anxiety and depression subscale scores on the Hospital Anxiety and Depression Scale compared to a placebo over the 6 week period.

Peripheral arterial diseases (PADs) are a collection of chronic occlusive conditions affecting adults, which predominately occur due to atherosclerosis and affects approximately 15% of the Australian population. Lipoprotein (a) [Lp(a)] is an emerging risk factor for PAD and atherosclerosis. Multiple studies have demonstrated a causal relationship between elevated Lp(a) and the development of atherosclerotic cardiovascular disease, calcific aortic valve disease and inflammation. The role of Lp(a) in restenosis in PAD is unclear, however Lp(a) is implicated in promoting atherosclerosis progression, thrombosis and inflammation which are all pathological processes thought to be critical in stimulating PAD progression and the need for surgical intervention. The primary aim of this study is to assess the relationship between serum Lp(a) concentration and the development of restenosis in 60 patients with aortoiliac PAD undergoing endovascular therapy up to 12 months post endovascular therapy.