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NCT Number: NCT03714789

Clearance and Pharmacokinetics of Antibiotics in Renal Replacement Therapy

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Ninth People's Hospital

Shanghai, China

About this study

This prospective, single-center observational study is taken to evaluate the dialysis clearance and pharmacokinetics of antibiotics with three different protein-bound levels in patients receiving renal replacement therapy. As is known that the plasma protein binding rate affects the distribution, metabolism and elimination of the drug in the body, and is also an important factor affecting the removal during dialysis, the study selects meropenem, vancomycin and ceftriaxone, of which the protein-bound levels are respectively 2%, 55% and 85%, to represent three typical protein-bound levels. The primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). The dialysis pattern, the antibiotic choice and its dosage for each subject are made on clinical grounds. A total of 16 milliliters of blood and 60 milliliters of spent dialysate are collected from each subject for each dialysis pattern. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • With Age from 18 to 85 years old.
  • With weight from 50 to 75 kilograms.
  • Requiring dialysis including intermittent hemodialysis(IHD) or hemodiafiltration(HDF).
  • Receiving meropenem, vancomycin or ceftriaxone based on clinical grounds.

Exclusion criteria

  • Patient is during pregnant or lactation period.
  • Patient is allergic to meropenem, vancomycin or ceftriaxone.
  • Severe hypoproteinemia (serum total protein<=45g/L) or severe hypoalbuminemia(serum albumin<20g/L).
  • Severe liver dysfunction(ALT>200U/L or AST>200U/L).
  • The patient himself or his immediate family refuses to sign the informed consent.

Treatment and study plan

Blood and spent dialysate collection

Other

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

Primary outcomes

  1. Dialytic clearance (K_total)

    Time frame: During the session of dialysis, up to 4 hours

    The total drug amount removed by dialysis

  2. Area under the concentration-time curve (AUC)

    Time frame: During the session of dialysis, up to 4 hours

    AUC based on plasma concentration during dialysis

Secondary outcomes

  1. Rebound of plasma concentration (Rebound_1h%)

    Time frame: At the end of dialysis and an hour after dialysis

    The rebound rate of plasma concentration 1 hour after dialysis

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Collaborators

  • Institute of Antibiotics, Huashan Hospital, Fudan University

Registry information

Official study title

Clearance and Pharmacokinetics of Antibiotics With Different Protein-bound Levels in Renal Replacement Therapy

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 22, 2018
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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