This study addresses the clinical problem that reliance on serum creatinine, eGFR or empirical dosing fails to accurately adjust anti-infective doses given rapid renal function shifts within the very early 0-5 days post kidney transplantation. We will systematically analyze dynamic trajectories of renal biomarkers (serum creatinine, cystatin C, urine output and other renal function indices), quantify their quantitative associations with the exposure, clearance and pharmacodynamic target attainment of anti-infectives. Combined with clinical profiles, medication data, TDM results and perioperative factors, a population PK/PD model will be built for patients in the very early post-transplant stage. We will further validate the value of dynamic renal markers for individualized anti-infective dosing. This research provides evidence for shifting from static renal function-based empirical dosing to precision dosing guided by real-time renal changes and drug exposure, supporting optimized anti-infective dosage, enhanced efficacy and medication safety in early kidney transplant recipients.
Aged >= 18 years old;
Patients receiving kidney transplantation within 0-5 days postoperatively;
Clinically planned administration of anti-infective agents for perioperative prophylaxis, empirical therapy or confirmed infection treatment, with an anticipated treatment duration of no less than 5 days;
Written informed consent obtained from the subject or legal surrogate;
Previous kidney transplantation or combined multi-organ transplantation
Patients requiring continuous renal replacement therapy in the early postoperative period
Severe hepatic dysfunction, defined as Child-Pugh class C, or ALT/AST > 5 times the upper limit of normal accompanied by markedly elevated bilirubin
Early postoperative use of ECMO, plasmapheresis or other extracorporeal therapies that substantially alter drug clearance
Zhongnan Hospital
Lead sponsor
Fudan University
Collaborator