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Clearance and Pharmacokinetics of Antibiotics in Renal Replacement Therapy

NCT ID: NCT03714789

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Meropenem

Patients requiring dialysis and receiving meropenem for infection or suspended infection.

Blood and spent dialysate collection

Intervention Type OTHER

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

Vancomycin

Patients requiring dialysis and receiving vancomycin for infection or suspended infection.

Blood and spent dialysate collection

Intervention Type OTHER

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

Ceftriaxone

Patients requiring dialysis and receiving ceftriaxone for infection or suspended infection.

Blood and spent dialysate collection

Intervention Type OTHER

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

Interventions

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Blood and spent dialysate collection

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Antibiotics, Huashan Hospital, Fudan University

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Ding Feng

Kidney internal medicine professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Feng Ding, PhD

Role: STUDY_DIRECTOR

Division of Nephrology,Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University

Locations

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Shanghai Ninth People's Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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PKDialysis-201710

Identifier Type: -

Identifier Source: org_study_id