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

THE DISCRIMINATIVE ABILITY OF PERCENT FREE PSA IN PATIENTS WITH PSA > 10 NG/ML

Objective To study the discriminative role of % free PSA in patients with a total PSA > 10 ng/ml. Patients and Methods Our patient cohort con-sisted of 90 males aged between 45 and 81 years (mean age: 67 ± 9 years). All patients had a biopsy-proven prostate pathology. Fifty-six patients had BPH (Group I) while 34 had prostate cancer (Group II). Blood samples were collected from all patients, and total PSA, free PSA and % free PSA were calculated in all specimens. Total PSA was measured using the Imx assay (Abbott, USA). The significance of the differences between the groups was assessed by the Mann-Whitney Wilcoxon rank sum test and Spearman's correlation coefficient for the correlation between % free PSA and the pathological diagnosis. Results The difference in total PSA between the two groups was insignificant. The mean value in BPH patients was 11.7 ± 11.4 ng/ml, while in patients with prostate cancer its was 15.8 ± 19.2 (p = 0.8). The mean % free PSA was 18 ± 1% in patients with BPH and 16 ± 0.6% in patients with prostate cancer (p = 0.3). A strong correlation was evident between % free PSA 15% and the pathological diagnosis (p = 0.87). This was also true for the cutoff values of 20% and 25% (p=0.79 and 0.62, respectively). Conclusion As a diagnostic test, % free PSA alone cannot be used for the discrimination of BPH from prostate cancer. In patients with a total PSA > 10 ng/ml, % free PSA has no value in the discrimination between benign and malignant pathology. Les Possibilités Discriminatives de la Fonction Libre de PSA chez les Patients dont le Taux de PSA est > 10mg/ml. Objectifs : Etude du rôle discriminatif de la fraction libre de PSA pour les patients dont le taux de PSA est supérieur à 10 mg/ml. Patients et Méthodes : Il s'agit d'une cohorte de 90 patients de sexe masculin âgés de 45 à 81 ans avec une moyenne d'âge de 67 ± 9 ans. Tous les patients ont subi des biopsies prostatiques avec étude histopathologique : 56 patients présentent une HBP (Groupe I) et 34 patients un cancer de la prostate (Groupe II). Un prélèvement de sang a été réalisé chez tous les patients avec un dosage du PSA total et de la fraction libre de PSA. Le PSA total a été mesuré par un kit IMX ( Abott, USA). L'étude statistique a été réalisée utilisant le Mann-Whitney Wilcoxon Rank test pour l'étude de la significativité de la différence entre les 2 groupes et le coefficient de corrélation de Spearman pour l'étude de la corrélation entre le rapport PSA libre/PSA totale et le diagnostic histologique. Résultats : La différence du PSA total entre les 2 groupes n'est pas significative. La moyenne des chiffres de PSA total dont l'anatomopathologie des biopsies a conclu à un cancer prostatique était de 11,7 ± 11,4 ng/ml alors que la moyenne chez le 2ème groupe présentant un cancer prostatique était de 15,8 ± 19,2 (P=0,8). La moyenne des rapports PSA libre/PSA total était de 18 ± 1% pour les patients présentant une HBP alors qu'elle était de 16 ± 0,6 % pour les patients présentant un cancer prostatique (P = 0,3). Une corrélation non significative a été remarquée entre un rapport PSA libre/PSA total de 15 % et le diagnostic histopathologique (P = 0,87). Ceci a été aussi vérifié pour une valeur charière de 20 % et 25 % (P=0,79 et 0,62 respectivement). Conclusion : Comme test diagnostic le rapport PSA libre / PSA total n'a pas de valeur discriminative entre une pathologie bénigne de la prostate et un cancer prostatique. African Journal of Urology Vol.9(1) 2003: 24-2

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.