MedicalResearch.com Interview with: Prof Giovanni Landoni, MD Associate Professor Università Vita-Salute San Raffaele Milan, Italy MedicalResearch.com: What is the background for this study? Response: Acute kidney injury (AKI) affects approximately 10-15% of hospitalized patients, and up to 50% of intensive care unit (ICU) patients. In cardiac surgery one patient out of three will face AKI during the postoperative period, and this will lead to higher morbidity and mortality. AKI is associated with an elevated risk of chronic kidney disease, as well as, in the most severe cases, with the use of renal replacement therapy, which may double hospitalization costs, reduce quality of life, and increase long-term mortality. So far, no preventive measure with level I of evidence did exist for AKI. The PROTECTION trial is a multinational, randomized, double-blind, placebo-controlled trial, conducted at 22 centers in 3 different countries. We recruited 3,511 adult patients undergoing cardiac surgery with cardiopulmonary bypass to receive an intravenous infusion of amino acids (AA) (Isopuramin 10%, Baxter), at 2g/kg/day up to a maximum 100g/day, or an equivalent dose of placebo (Ringer’s solution), for a maximum of 72 hours. The primary outcome was the incidence of any stage of AKI, according to the Kidney Disease: Improving Global Outcomes (KDIGO) 2012 creatinine criteria. (more…)