Vancomycin-associated nephrotoxicity: prospective study of the incidence, risk factors and mortality in non-critical patients

• Grant number: 16/11915-8
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Effective date (Start): September 01, 2016
• Effective date (End): September 30, 2018
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Daniela Ponce
• Grantee: Isabella Gonçalves Pierri
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

Acute kidney injury (AKI) is one of the most important complications in hospitalized patients, as well as an independent death risk factor. Its main cause is acute tubular necrosis due to ischemia followed by nephrotoxicity mechanism.The incidence of AKI associated with the use of the vancomycin varies from 5 to 35% and different factors may enhance the occurrence of nephrotoxicity, which may be related to the patient (age, reduced renal function); the concomitant use of other nephrotoxic drugs and intravenous contrast agents; and treatment, as extended duration, high-dose and dose fractionation. There are also risk factors that often act as confounding factors, including the presence of sepsis, major burns and acute pancreatitis. The use of vancomycin must be accompanied by correction of your dose for patients with renal impairment and monitoring of serum levels in patients at high risk of renal dysfunction. Although high concentrations cause concern, it is recommended to maintain the level of vancomycin always above 10mg/L, to prevent the development of bacterial resistance and minimize the risk of treatment failure. Thus, further studies are needed to determine the prevalence of nephrotoxic AKI by vancomycin in different populations, and identify risk factors for its development and prognosis.The objectives of this study are to evaluate the incidence of AKI associated with the use of vancomycin in hospitalized patients in medical and surgical wards, identify risk factors for its development and associated with death. A prospective observational cohort study of patients on vancomycin use enrolled in four wards of the Hospital of the Faculty of Medicine of Botucatu (UNESP) will be held during the period from 08/2016 to 07/2017 daily and without interruption. Patients who do not receive vancomycin during hospitalization will be excluded, in addition to patients with CKD stage 5 (CrCl <15ml / min), renal transplant recipients, patients with shock of any etiology, in use of vasoactive drugs and other nephrotoxic medications, and those with LRA in the first 48 h of admission or use of vancomycin.Each patient will have completed an agreement with clinical and laboratory information, data ever obtained by the same observer from the admission of the patient in the wards until the end of the use of vancomycin or its outcome (discharge or death). Assessment of renal function is performed daily by Serum creatinine and urinary output check and diagnosis of AKI it will be held by the criteria of KDIGO 2012. The results will be presented by descriptive statistics of the study population and different statistical tests according to the study objectives. It will be established as the dependent variable the occurrence of AKI, using the chi-square test for statistical significance between this variable and categorical variables and the t test for this variable and continuous variables. After, multivariate analysis will be performed for the construction of the logistic regression model, with calculations OddsRatio (OR), and included in the model all the independent variables associated with the outcome, with pd0,20. All test results hypothesis will be discussed in the 5% level of significance (p <0.05).