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

Early coagulation support protocol: A valid approach in real-life management of major trauma patients. Results from two Italian centres

Introduction: Early coagulation support (ECS) includes prompt infusion of tranexamic acid, fibrinogen concentrate, and packed red blood cells for initial resuscitation of major trauma patients. The aim of this study was to determine the effects, in terms of blood product consumption, length of stay, and in-hospital mortality, of the ECS protocol, compared to the massive transfusion protocol (MTP) in the treatment of major trauma patients. Patients and methods: A retrospective analysis was conducted using the registry data of two Italian trauma centres. Adult major trauma patients with, or at risk of, active bleeding who were managed according to the MTP during the years 2011\u20132012, or the ECS protocol during the years 2013\u20132014 and were considered at risk of multiple transfusions, were enrolled. The primary endpoint was to determine whether the ECS protocol reduces the use of blood products in the acute management of trauma patients. Secondary endpoints were the outcome measures of length of stay in ICU, length of stay in hospital, and mortality at 24-hours and 28-days after hospital admission. Results: Among the 518 major trauma patients admitted to the trauma centres during the study period, 235 patients (118 in the pre-ECS period and 117 in the ECS period) matched one of the inclusion criteria and were enrolled in the study. Compared with the pre-ECS period, the ECS period showed a reduction in the average consumption of packed red blood cells ( 121.87 units, 95% confidence interval [CI], 122.40, 121.34), platelets ( 121.28 units; 95% CI, 121.64, 120.91), and fresh frozen plasma ( 121.69; 95% CI, 122.14, 121.25) in the first 24-hours. Furthermore, during the ECS period, we recorded a 10-day reduction in the hospital length of stay ( 1210 days, 95% CI, 1211.6, 128.4) and a non-significant 28-day mortality increase. Conclusions: The ECS protocol was effective in reducing blood product consumption compared to the MTP and confirmed the importance of early fibrinogen administration as a strategy of rapid coagulation. This novel approach may be adopted in real-life management of major trauma patients

Polymyxin-B hemoperfusion in septic patients: analysis of a multicenter registry

Background: In 2010, the EUPHAS 2 collaborative group created a registry with the purpose of recording data from critically ill patients suffering from severe sepsis and septic shock treated with polymyxin-B hemoperfusion (PMX-HP) for endotoxin removal. The aim of the registry was to verify the application of PMX-HP in the daily clinical practice. Methods: The EUPHAS 2 registry involved 57 centers between January 2010 and December 2014, collecting retrospective data of 357 patients (297 in Europe and 60 in Asia) suffering from severe sepsis and septic shock caused by proved or suspected infection related to Gram negative bacteria. All patients received atleast one cycle of extracorporeal endotoxin removal by PMX-HP. Results: Septic shock was diagnosed in 305 (85.4\ua0%) patients. The most common source of infection was abdominal (44.0\ua0%) followed by pulmonary (17.6\ua0%). Gram negative bacteria represented 60.6\ua0% of the pathogens responsible of infection. After 72\ua0h from the first cycle of PMX-HP, some of the SOFA score components significantly improved with respect to baseline: cardiovascular (2.16\ua0\ub1\ua01.77 from 3.32\ua0\ub1\ua01.29, p\ua0<\ua00.0001), respiratory (1.95\ua0\ub1\ua00.95 from 2.40\ua0\ub1\ua01.06, p\ua0<\ua00.001) and renal (1.84\ua0\ub1\ua01.77 from 2.23\ua0\ub1\ua01.62, p\ua0=\ua00.013). Overall 28-day survival rate was 54.5\ua0% (60.4\ua0% in abdominal and 47.5\ua0% in pulmonary infection). Patients with abdominal infection treated with PMX-HP within 24\ua0h from the diagnosis of septic shock had a 28-day survival rate of 64.5\ua0%. Patients showing a significantly cardiovascular improvement after PMX-HP had a 28-survival rate of 75\ua0% in comparison to the 39\ua0% of patients who did not (p\ua0<\ua00.001). Cox regression analysis found the variation of cardiovascular, respiratory and coagulation SOFA to be independent covariates for 28-day survival. In European patients were observed a higher 28-day (58.8 vs. 34.5\ua0%, p\ua0=\ua00.003), ICU (59 vs. 36.7\ua0%, p\ua0=\ua00.006) and hospital survival rate (53.2 vs. 35\ua0%, p\ua0=\ua00.02) than in Asian patients. However, the two populations were highly heterogeneous in terms of source of infection and severity scores at admission. Conclusion: The EUPHAS 2 is the largest registry conducted outside Japan on the clinical use of PMX-HP in septic patients. Data analysis confirmed the feasibility of PMX-HP to treat septic patients in daily clinical practice, showing clinical benefits associated with endotoxin removal without significant adverse events related to the extracorporeal technique. \ua9 2016, The Author(s)

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.