The role of biomarkers as diagnostic and prognostic predictors of acute kidney injury in decompensated liver cirrhotic patients

• Grant number: 22/13560-3
• Support Opportunities: Regular Research Grants
• Start date: March 01, 2023
• End date: February 28, 2025
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Daniela Ponce
• Grantee: Daniela Ponce
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

Acute kidney injury (AKI) is a frequent complication in decompensated liver disease, contributing to the unacceptably high morbidity and mortality of these patients. Currently, serum creatinine is the biomarker of choice for the diagnosis and classification of AKI, however, it is influenced by a number of factors that make its use inaccurate and late, both in diagnosis and prognosis. Therefore, it is necessary to analyze the role of other biomarkers as diagnostic and prognostic predictors of AKI in patients with liver disease. OBJECTIVES: Thus, the main objective of this study is to evaluate the role of biomarkers NGAL, KIM-1 and IL-18 as diagnostic and prognostic predictors of AKI in decompensated patients with liver disease admitted to a public and tertiary hospital. METHODS: A prospective observational cohort study of cirrhotic patients admitted to a public university hospital from December 2022 to December 2023 will be carried out. collection of urinary samples. The sample size was calculated, considering that the difference in urinary value of biomarkers between the population with and without ARI will be 5 ug/ml, standard deviation of 8 ug/ml, alpha error of 0.05, power of study than 80%, requiring the inclusion of at least 80 patients. For each patient, a protocol will be filled out with clinical and laboratory data obtained by the same observer from admission to outcome (discharge or death). Urine samples will be collected for biomarker dosage in the first 24 hours of hospital admission. The diagnosis of ARI will be performed by the creatinine criteria established by KDIGO 2012 and International Ascites Club. The results will be presented using descriptive statistics of the studied population and different statistical tests according to the objectives of the study. The population with and without ARI will be evaluated and compared according to the quintiles of the biomarkers. Area under the roc curve will be used to determine the ability of biomarkers to discriminate the diagnosis and prognosis of AKI. At the end of the study, patients' Kaplan Meyer curves will be presented during the follow-up period. All hypothesis test results will be discussed at the 5% significance level (p<0.05). (AU)