Clearance and Pharmacokinetics of Antibiotics in Renal Replacement Therapy

NCT03714789 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2020-10-26

No results posted yet for this study

Summary

This is an observational study that evaluates the dialysis clearance and pharmacokinetics of antibiotics with different protein-bound levels in patients receiving renal replacement therapy. Meropenem, vancomycin and ceftriaxone are selected to represent three typical protein-bound levels, and the primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). During and after the dialysis, the drug levels in both plasma and spent dialysate are monitored, but no changes are made to therapy. The study will provide detailed information on the characteristics of the removal kinetics of the three antibiotics during dialysis, and evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets while minimizing the risk of toxicity.

Conditions

Interventions

OTHER

Blood and spent dialysate collection

A certain amount of blood and spent dialysate are collected during and after dialysis for quantification of drug concentration.

Sponsors & Collaborators

  • Institute of Antibiotics, Huashan Hospital, Fudan University

    collaborator UNKNOWN
  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    lead OTHER

Principal Investigators

  • Feng Ding, PhD · Division of Nephrology,Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-12-30
Completion
2020-10-01

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03714789 on ClinicalTrials.gov