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

Relation of Plasma Fibrinogen Level with the Presence, Severity, and Complexity of Coronary Artery Disease

Background: Relation of plasma fibrinogen levels with extent, severity, and complexity of coronary artery disease (CAD) in patients with stable angina pectoris (SAP) has not been adequately investigated. The aim of this study was to evaluate whether plasma fibrinogen level is associated with coronary complexity, severity, and extent assessed by SYNTAX (Synergy between percutaneous coronary intervention with TAXUS and Cardiac Surgery) score (SS). Methods: We enrolled 134 consecutive patients with SAP who underwent coronary angiography. Baseline serum fibrinogen levels were measured, and SS was calculated from the study population. The patients were classified into 3 groups by tertiles of SS (SS, control group = 0; intermediate group &lt; 22; and high group ≥ 22). Results: Plasma fibrinogen levels demonstrated a stepwise increase from control group to high SS group. There was a strong correlation between fibrinogen and the SS ( r = .535, P &lt; .001). Area under the receivers operating characteristic curve of fibrinogen was 0.72 (95% confidence interval [CI] 0.61-0.82; &lt; .001) for predicting a high SS. Fibrinogen value higher than 411 mg/dL has a sensitivity of 75% and a specificity of 64% in prediction of high SS. In multivariate analyses, plasma fibrinogen was observed to be an independent predictor for high SS in patients with stable CAD (odds ratio [OR] 1.01; 95% CI, 1.01-1.02; P &lt; .001). Conclusion: Plasma fibrinogen is a readily measurable systemic inflammatory marker and is independently associated coronary severity and complexity in patients with CAD. </jats:sec