The role of monitoring vancomycin and amikacin levels in plasma and dialysate of patients with peritonitis associated with peritoneal dialysis

• Grant number: 18/13690-9
• Support Opportunities: Regular Research Grants
• Duration: January 01, 2019 - December 31, 2020
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: André Luís Balbi
• Grantee: André Luís Balbi
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil
• Associated researchers: Daniela Ponce
• Associated scholarship(s): 19/01408-0 - The role of monitoring the levels of vancomycin and amikacin in plasma and dialysate of patients with peritonitis associated with peritoneal dialysis, BP.TT

Abstract

Introduction: Peritonitis is a serious complication related to the dialysis method and has high rates of morbidity and mortality in patients on peritoneal dialysis (PD), being the main cause of transition to hemodialysis. Aminoglycoside and vancomycin are options for empirical treatment, with spectrum for gram-negative and positive germs, respectively and should be administered intraperitoneally (IP). However, the systemic absorption of these antimicrobials is controversial. Objectives: This study aims to evaluate the plasma levels and the amikacin and vancomycin dialysate at peak (30 minutes after administration) and valley (before the next administration), as well as to analyze the prevalence of adequate, subtherapeutic and toxic levels, as well as to establish a relationship between plasma and dialysate concentrations of drugs. Secondary objectives of the study are to analyze the impact of inadequate serum levels of vancomycin and amikacin on refractory peritonitis and technique failure rates (need for catheter replacement or change of dialysis method) and to analyze the impact of toxic levels of vancomycin and amikacin about residual renal function.. Methodology: It is an observational study that will be performed from October 2018 to October 2021 and will include 50 patients in PD with episode of peritonitis treated with amikacin or vancomycin IP. Patients younger than 18 years, pregnant women, those receiving intravenous vancomycin and peritonitis recurrence will be excluded. Sample of blood and dialysate will be analyzed after 30 minutes of the antibiotic infusion in the peritoneal cavity at the 1st, 3rd and 5th days (peak therapeutic levels of amikacin between 25 and 35 mg /l and vancomycin of 30 to 40 mg /l) and before infusion of the drug. dialysate with antibiotic on the 3rd and 5th days (therapeutic levels in the amikacin valley between 4 and 8 mg / dl and vancomycin between 10 and 20 mg / l). The analytical stage will be carried out at the Institute of Chemistry of the Faculty of Chemistry of Bauru - UNESP. Quantification of antimicrobials in the biological matrix (plasma and dialysate) will be carried out using high performance liquid chromatography (HPLC) using validated and developed bioanalytical methods. In addition, partial validation of these methods will be performed in liquid chromatography systems on ultraviolet-visible detectors. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

FALBO DOS REIS, PAMELA; BARRETTI, PASQUAL; MARINHO, LAUDILENE; BALBI, ANDRE LUIS; AWDISHU, LINDA; PONCE, DANIELA. Pharmacokinetics of Intraperitoneal Vancomycin and Amikacin in Automated Peritoneal Dialysis Patients With Peritonitis. FRONTIERS IN PHARMACOLOGY, v. 12, MAY 28 2021. (18/13690-9, 19/02116-2)