EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI) : Study protocol for a multicentre, observational trial

More than 300 million surgical procedures are performed each year. Acute kidney injury (AKI) is a common complication after major surgery and is associated with adverse short-term and long-term outcomes. However, there is a large variation in the incidence of reported AKI rates. The establishment of an accurate epidemiology of surgery-associated AKI is important for healthcare policy, quality initiatives, clinical trials, as well as for improving guidelines. The objective of the Epidemiology of Surgery-associated Acute Kidney Injury (EPIS-AKI) trial is to prospectively evaluate the epidemiology of AKI after major surgery using the latest Kidney Disease: Improving Global Outcomes (KDIGO) consensus definition of AKI. EPIS-AKI is an international prospective, observational, multicentre cohort study including 10 000 patients undergoing major surgery who are subsequently admitted to the ICU or a similar high dependency unit. The primary endpoint is the incidence of AKI within 72 hours after surgery according to the KDIGO criteria. Secondary endpoints include use of renal replacement therapy (RRT), mortality during ICU and hospital stay, length of ICU and hospital stay and major adverse kidney events (combined endpoint consisting of persistent renal dysfunction, RRT and mortality) at day 90. Further, we will evaluate preoperative and intraoperative risk factors affecting the incidence of postoperative AKI. In an add-on analysis, we will assess urinary biomarkers for early detection of AKI. EPIS-AKI has been approved by the leading Ethics Committee of the Medical Council North Rhine-Westphalia, of the Westphalian Wilhelms-University Münster and the corresponding Ethics Committee at each participating site. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and used to design further AKI-related trials. Trial registration number NCT04165369

Comparative study of two radiotherapy regimens for palliation of symptomatic advanced non-small cell lung cancer

Introduction: Lung cancer is the most commonly diagnosed cancer worldwide and causes approximately 1–2 million deaths per year. Non-small cell lung cancer (NSCLC) accounts for at least 80% of all lung cancer cases, presenting as locally advanced disease in approximately 25–30% of cases and as metastatic disease in approximately 40–50% of cases. Aim of the work: To compare symptom control in patients with inoperable, locally advanced or metastatic NSCLC using two different regimens of palliative external beam radiotherapy (RT), and to determine toxicity profile, health related quality of life (HRQOL), tumor control, and overall survival. Patients and methods: A prospective clinical study included 30 patients who were randomly assigned into two groups; group (A) 15 patients received RT regimen of 10 fractions of 3 Gy over 2 weeks to a total dose of 30 Gy, and group (B) 15 patients received RT regimen of two fractions of 8.5 Gy days 1 and 8 to a total dose of 17 Gy. All patients in the study were subjected to the following; pretreatment evaluation, RT, patient’s assessment, HRQOL, tumor control, and overall survival. Results: The hypo fractionated RT regimens used in this study proved to be equally effective as the more protracted regimen in terms of palliation of the intrathoracic symptoms, treatment tolerance, HRQOL, and overall survival. This may hopefully convince at least some radiation oncologists still using more protracted regimens to adopt this simple and efficient treatment. Conclusion: Palliative RT plays an important role of palliation of symptomatic intra thoracic disease and in preservation of HRQOL in patients who have limited expected survival time and or intolerance to combined chemotherapy and radical RT regimens

EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): Study protocol for a multicentre, observational trial

Introduction More than 300 million surgical procedures are performed each year. Acute kidney injury (AKI) is a common complication after major surgery and is associated with adverse short-term and long-term outcomes. However, there is a large variation in the incidence of reported AKI rates. The establishment of an accurate epidemiology of surgery-associated AKI is important for healthcare policy, quality initiatives, clinical trials, as well as for improving guidelines. The objective of the Epidemiology of Surgery-associated Acute Kidney Injury (EPIS-AKI) trial is to prospectively evaluate the epidemiology of AKI after major surgery using the latest Kidney Disease: Improving Global Outcomes (KDIGO) consensus definition of AKI. Methods and analysis EPIS-AKI is an international prospective, observational, multicentre cohort study including 10 000 patients undergoing major surgery who are subsequently admitted to the ICU or a similar high dependency unit. The primary endpoint is the incidence of AKI within 72 hours after surgery according to the KDIGO criteria. Secondary endpoints include use of renal replacement therapy (RRT), mortality during ICU and hospital stay, length of ICU and hospital stay and major adverse kidney events (combined endpoint consisting of persistent renal dysfunction, RRT and mortality) at day 90. Further, we will evaluate preoperative and intraoperative risk factors affecting the incidence of postoperative AKI. In an add-on analysis, we will assess urinary biomarkers for early detection of AKI. Ethics and dissemination EPIS-AKI has been approved by the leading Ethics Committee of the Medical Council North Rhine-Westphalia, of the Westphalian Wilhelms-University Münster and the corresponding Ethics Committee at each participating site. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and used to design further AKI-related trials. Trial registration number NCT04165369.