Trials
-
Randomized Controlled Trial Multicenter Study
Effects of a transitional palliative care model on patients with end-stage heart failure: study protocol for a randomized controlled trial.
Heart failure (HF) is characterized by high rates of readmission after hospitalization, and readmission is a major contributor to healthcare costs. The transitional care model has proven efficacy in reducing the readmission rate and economic outcomes, and increasing satisfaction with care. However, the effectiveness of the transitional care model has not been evaluated in patients with end-stage HF. This study was designed to compare the customary hospital-based care and a comprehensive transitional care model, namely the Home-based Palliative HF Program (HPHP), in terms of readmission rate, quality of life, and satisfaction with care among end-stage HF patients under palliative care. ⋯ This study is original and will provide important information for service development in the area of palliative care. The introduction of palliative care to end-stage organ failure patients is new and has received increasing attention worldwide in the last decade. This study adopts the randomized controlled trial, a vigorous research design, to establish scientific evidence in exploring the best model for end-stage HF patients receiving palliative care.
-
Randomized Controlled Trial Multicenter Study
CAMERA2 - combination antibiotic therapy for methicillin-resistant Staphylococcus aureus infection: study protocol for a randomised controlled trial.
Methicillin-resistant Staphylococcus aureus (MRSA) bacteraemia is a serious infection resulting in 20-50 % 90-day mortality. The limitations of vancomycin, the current standard therapy for MRSA, make treatment difficult. The only other approved drug for treatment of MRSA bacteraemia, daptomycin, has not been shown to be superior to vancomycin. Surprisingly, there has been consistent in-vitro and in-vivo laboratory data demonstrating synergy between vancomycin or daptomycin and an anti-staphylococcal β-lactam antibiotic. There is also growing clinical data to support such combinations, including a recent pilot randomised controlled trial (RCT) that demonstrated a trend towards a reduction in the duration of bacteraemia in patients treated with vancomycin plus flucloxacillin compared to vancomycin alone. Our aim is to determine whether the addition of an anti-staphylococcal penicillin to standard therapy results in improved clinical outcomes in MRSA bacteraemia. ⋯ Key potential advantages of adding anti-staphylococcal β-lactams to standard therapy for MRSA bacteraemia include their safety profile, low cost, and wide availability.
-
Randomized Controlled Trial Multicenter Study
Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: study protocol for a randomized controlled trial.
Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and contributes to nearly a quarter of maternal deaths globally. The current available interventions for prevention of postpartum haemorrhage, oxytocin and carbetocin, are limited by their need for refrigeration to maintain potency, as the ability to maintain a cold chain across the drug distribution and storage network is inconsistent, thus restricting their use in countries with the highest burden of maternal mortality. We describe a randomized, double-blind non-inferiority trial comparing a newly developed room temperature stable formulation of carbetocin to the standard intervention (oxytocin) for the prevention of PPH after vaginal birth. ⋯ If the results of the study show that room temperature stable carbetocin is a safe and effective alternative to oxytocin, this could have a substantial impact on the prevention of postpartum haemorrhage and maternal survival worldwide.
-
Randomized Controlled Trial Multicenter Study
Xuebijing injection in the treatment of severe pneumonia: study protocol for a randomized controlled trial.
Severe pneumonia (SP) is a major complication of respiratory system diseases that is associated with high mortality and morbidity. If not treated correctly, it may rapidly lead to sepsis and multiple organ dysfunction syndrome. Despite continuous developments in antibiotic treatments for SP, the mortality rate remains high. Both basic and clinical research show that Xuebijing injection (XBJ) can improve the symptoms of SP. The aim of this study is to evaluate the effectiveness and safety of XBJ compared with placebo. ⋯ This is the first and largest randomized trial done in China on SP treatment using a Chinese herbal extract. In this trial, we will use central randomization and an electronic case report form, and we have designed an innovative blinding method for the traditional Chinese medicine injection. The results of this trial may help to provide evidence-based recommendations to clinicians for treatment of SP.
-
Randomized Controlled Trial Multicenter Study Comparative Study
Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer (PREOPANC trial): study protocol for a multicentre randomized controlled trial.
Pancreatic cancer is the fourth largest cause of cancer death in the United States and Europe with over 100,000 deaths per year in Europe alone. The overall 5-year survival ranges from 2-7 % and has hardly improved over the last two decades. Approximately 15 % of all patients have resectable disease at diagnosis, and of those, only a subgroup has a resectable tumour at surgical exploration. Data from cohort studies have suggested that outcome can be improved by preoperative radiochemotherapy, but data from well-designed randomized studies are lacking. Our PREOPANC phase III trial aims to test the hypothesis that median overall survival of patients with resectable or borderline resectable pancreatic cancer can be improved with preoperative radiochemotherapy. ⋯ The PREOPANC trial is designed to investigate whether preoperative radiochemotherapy improves overall survival by means of increased (R0) resection rates in patients with resectable or borderline resectable pancreatic cancer.