ANZCTR search results

A pilot study: As part of our standard care, in line with a comprehensive blood management approach, patients presenting for primary hip arthroplasty are offered intra-operative cell salvage. One type of cell saver used is the SANGVIA system. Blood is collected during surgery, filtered and can be reinfused post-operatively. This is a relatively new technology and there is some controversy around the efficacy, safety and potential adverse effects of the reinfusion. This includes some concern whether a coagulopathy might be induced by reinfusion through various mechamisms. of cytokines. A "point of care device" "ROTEM" is well established in clinical medicine. It is comprehensive diagnostic system coagulation management. We would like to assess the patients' clotting profile before incision and the potential impact of reinfusion of the salvaged blood at the end of the operation. This will be conducted with ROTEM , testing for ex-TEM S (screening extrinsic clotting pathway & platelet contribution to clot formation), in-TEM S (screening intrinsic clotting pathway & platelet contribution to clot formation)compared to standard Lab testing (INR, aPTT). A small sample volume of the shed blood is collected and analyed for haemoglobin and platelets to assess the quality and composition of the blood. In addition a 2nd sample is frozen which will be analyzed after completion of the study to assess the presence and levels of imflammatory mediators.

Cardiac arrest is a relatively common and devastating event in Australia and New Zealand (ANZ). It is associated with extremely high mortality. A large proportion of those who survive are left with serious neurological disability. Such disability includes memory loss, paralysis and difficulty in thinking and speaking. These deficits often lead to a loss of independence and the need to be admitted to aged-care facilities. Immediate cardio-pulmonary resuscitation and defibrillation by bystanders has only partly improved the outcome of these patients. For those who survive the immediate phase and are admitted to the intensive care unit, actively decreasing the body temperature to 33-34 degrees C has been shown to protect the brain. Although limited, these results suggest that some interventions after cardiac arrest can improve brain outcome. Perhaps other interventions could lead to similar results and further improve patient’s recovery and quality of life after cardiac arrest. In a recent observational study in 12,000 ANZ patients who were admitted in ICU after a cardiac arrest, we found that those who had an elevated partial pressure of carbon dioxide (PaCO2) in the 24 hours following the cardiac arrest had a higher chance of having a satisfactory neurological recovery. These patients were 20% more likely to be able to go back home at the end of their hospital stay as compared with those whose PaCO2 was either in the normal or low range. These findings are similar to those seen in previous animal studies. They also make physiological sense: a higher PaCO2 is known to trigger an increase in the amount of blood directed towards the brain. An increase in brain blood flow after a cardiac arrest (a state of no flow) should be logically associated with a higher chance of recovery. However, these findings need to be confirmed by prospective trials before they can be applied to all patients with a cardiac arrest. PaCO2 is normally controlled by the lungs and its arterial partial pressure is directly related to the rate and amplitude of the breathing process. After a cardiac arrest, patients typically are unconscious or heavily sedated by medication and their breathing process is almost entirely taken care of by a ventilator (breathing machine). In such circumstances, the PaCO2 is determined by the medical team. Currently, a “normal” value for PaCO2 (35-45 mmHg) is targeted by clinicians. However, changing this target value to 50-55 mmHg, would be technically easy to implement and carry no extra cost. Based on the findings of our retrospective study (Schneider et al, Resuscitation 2013), on animal studies and logic, we hypothesize that a higher PaCO2 in the first 24 hours after cardiac arrest will be associated with less neurological injury and be feasible and safe. To test this hypothesis, we plan to randomly allocate 75 patients admitted to ICU after cardiac arrest to either “High PaCO2” or “Control” group. The pan to enrol 75 participants is purposeful. This approahc willl provide the means to obtain a complete set of brain biomarker samples (those being baseline, 24 hour, 36 hour and 72 hour) for a total of 50 participants. The key outcomes of interest would be whether such trial can be done, whether this therapy appears safe and whether it decreases blood test-based markers of brain injury (brain proteins like neuron specific enolase and S100 protein), indicating that a biological benefit is taking place.

Ambulatory surgery is performed as an outpatient day-only procedure, and is considered minor surgery. Anaesthesia for this type of surgery can be with general anaesthesia (GA) only, or GA in combination with regional anaesthesia (RA). However, while it is assumed that outpatient surgery constitutes minor surgical stress, there are sufficient case series observing severe cognitive dysfunction and poorer than expected functional recovery even after brief surgery. Anaesthetists have used RA techniques on the assumption that an effective nerve block allows a reduction in GA doses, better and prolonged analgesia, and a positive influence on post-operative recovery. This study will help anaesthetists determine if anaesthetic choices will lead to better outcomes for their patients undergoing minor ambulatory surgery. The primary endpoint of this study is the incidence of cognitive recovery at day 3 between groups. Secondary endpoints will be recovery in other domains, over time.

This study will investigate the effect of different varieties of sweetpotatoes and potatoes prepared by different methods on feeling of hunger/ fullness and other blood measurements related to health after consumption of a test meal. The significance of this study is to identify which types of potatoes and sweetpotatoes reduce hunger the most and lower blood glucose, insulin, ghrelin and oxidative stress biomarkers and thus may be recommended as part of a healthy diet in order to reduce the risk of obesity, diabetes and heart disease.

This research project aimed to investigate aspects of energy requirements, energy intake and body composition in a population of preschool aged children with cerebral palsy. Results and outcomes will help inform clinical practice for this population and direct future research.

The primary purpose of the study is to test the efficacy of HFNP WHO compared to standard oxygen therapy (cold low flow) in the treatment of acute moderate bronchiolitis using time to event data (time to oxygen weaning) as the primary outcome. Three supporting safety outcomes and several exploratory outcomes are included in this single site clinical trial.

It is estimated that over 300,000 Australians have heart failure (HF) at any given time and the incidence increases with increase in life expectancy. The point prevalence of chronic heart failure (CHF) has been about 1% in people aged 50–59 years, 10% in people aged over 65 years, and over 50% in people aged greater than 85 years. Despite therapeutic advances, HF remains a disease with unacceptably high mortality rates, poor quality of life and massive socioeconomic cost. Heart failure with preserved ejection fraction (HF-PEF) previously known as diastolic heart failure accounts for about 50% of patients with heart failure. HF-PEF refers to a clinical syndrome of symptoms and clinical signs of HF, normal or near normal left ventricular (LV) systolic function (EF> 50%) and evidence of diastolic dysfunction in the form of abnormal LV filling and elevated filling pressures. This can be objectively confirmed on echocardiogram. There is no difference in morbidity between patients with heart failure with reduced ejection fraction and those with preserved ejection fraction and some studies have shown similar mortality in the two conditions. The efficacy for beta blockers, angiotensin converting enzyme inhibitors (ACE-I), angiotensin receptor blockers (ARB) and aldosterone antagonists is well established in the treatment of HF with reduced EF. The efficacy for these drugs in HF-PEF is not well established. The I-PRESERVE trial studied the effects of Irbesartan (ARB) in symptomatic patients with HF-PEF. 4128 patients were enrolled and followed up for 4 years. There was no improvement in outcomes in patients on Irbesartan. The CHARM preserved trial studied Candesartan in 3000 patients with HF-PEF for a period of 3 years. There was only a small reduction in hospital admissions for heart failure in the Candesartan group.The PEP-CHF trial assessed the efficacy of Perindopril (ACE-I) in 850 patients over the age of 70 with HF-PEF. At one year there were fewer unexpected hospital admissions for heart failure in the perindopril group although the trial when completed showed no difference in its primary end point. Although therapies have proven effective in reducing morbidity and mortality from heart failure with reduced ejection fraction, mortality from HF-PEF remains unchanged. No therapies thus far have been proven to correct the abnormalities seen in HF-PEF, halt its progression, reduce its mortality or conclusively reduce its morbidity. Rationale. 1. That the addition of the phosphodiestrase-5 (PDE-5) inhibitor tadalafil will improve symptoms, exercise tolerance, pulmonary arterial pressure, right ventricular (RV) function and LV relaxation in patients with HF- PEF. Objectives. The primary objective of the study is to trial a novel agent in the treatment of HF-PEF as patients continue to be symptomatic on currently available medications. 1. We propose to use the PDE-5 inhibitor tadalafil which selectively dilates pulmonary vessels and has beneficial effects on RV function in patients with HF-PEF and assess the effect on symptoms, exercise tolerance, echocardiographic and Cardiovascular Magnetic Resonance (CMR) imaging parameters of heart failure.

This project involves an investigation amongst noise-exposed professional orchestral musicians into the usability of an electronic hearing protection device. The device is specifically designed for musicians and apparently capable of delivering hi-fidelity sound to the ear at a level that will protect the wearer from noise-induced hearing loss in a performance or rehearsal setting. Twenty-four musicians selected from two professional orchestras will be fitted with the device and be closely monitored for both their reaction to and their use of the device over a period of four weeks during ‘at-risk’ activities. The actual attenuation provided by the device will be determined in each subject using standard audiological test techniques. The device will also be subjected to laboratory testing to determine if manufacturer’s claims of attenuation and fidelity are reproducible.

Background: Uncontrolled asthma during pregnancy is associated with the maternal hazards of disease exacerbation, and perinatal hazards including intrauterine growth restriction and preterm birth. Interventions directed at achieving better asthma control during pregnancy should be considered a high priority in order to optimise both maternal and perinatal outcomes. Poor compliance with prescribed asthma medications during pregnancy and suboptimal prescribing patterns to pregnant women have both been shown to be contributing factors that jeopardise asthma control. The aim is to design and evaluate an intervention involving multidisciplinary care for women experiencing asthma in pregnancy. Methods/Design: A randomized controlled trial testing a Multidisciplinary Approach to Management of Maternal Asthma (MAMMA[copyright]) which involves education and regular monitoring. Pregnant women with asthma will be recruited from antenatal clinics of one maternity hospital in Victoria, Australia. Recruited participants, stratified by disease severity, will be allocated to the intervention or the usual care group in a 1:1 ratio. Both groups will be followed prospectively throughout pregnancy and outcomes will be compared between groups at three and six months after recruitment to evaluate the effectiveness of this intervention. Outcome measures include Asthma Control Questionnaire (ACQ) scores, oral corticosteroid use, asthma exacerbations and asthma related hospital admissions, and days off work, preventer to reliever ratio, along with pregnancy and neonatal adverse events at delivery. The use of FEV1/FEV6 will be also investigated during this trial as a marker for asthma control. Discussion: If successful, this model of care could be widely implemented in clinical practice and justify more funding for support services and resources for these women. This intervention will also promote awareness of the risks of poorly controlled asthma and the need for a collaborative, multidisciplinary approach to asthma management during pregnancy. This is also the first study to investigate the use of FEV1/FEV6 as a marker for asthma control during pregnancy.

This study aims to assess the agreement between the laboratory measurement of blood haemoglobin and that obtained from two devices which measure haemoglobin at the patients bedside thus providing rapid results which can be used to guide management. One is the HemoCue 'Registered Trademark' device measures Hb concentration from very small amounts of blood either from a finger prick or the veins, the other is the Masimo Pronto-7 'Registered Trademark' spectrophotometry device measures Hb concentration non-invasively using light sensors on a finger probe similar to those used to measure the amount of oxygen in the blood.