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Clearance and Pharmacokinetics of Antibiotics in Renal Replacement Therapy

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ClinicalTrials.gov Identifier: NCT03714789
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Collaborator:
Institute of Antibiotics, Huashan Hospital, Fudan University
Information provided by (Responsible Party):
Ding Feng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief 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.

Condition or disease Intervention/treatment
Kidney Failure Other: Blood and spent dialysate collection

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clearance and Pharmacokinetics of Antibiotics With Different Protein-bound Levels in Renal Replacement Therapy
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Dialysis

Group/Cohort Intervention/treatment
Meropenem
Patients requiring dialysis and receiving meropenem for infection or suspended infection.
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.

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients aged from 18 to 85 years, requiring dialysis including intermittent hemodialysis(IHD) or hemodiafiltration(HDF), and receiving meropenem, vancomycin or ceftriaxone based on clinical grounds from a university-affiliated hospital in Shanghai, China.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714789


Contacts
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Contact: Feng Ding, PhD 86-21-53315165 dingfeng@sjtu.edu.cn

Locations
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China
Shanghai Ninth People's Hospital Recruiting
Shanghai, China
Contact: Feng Ding, PhD    86-21-53315165    dingfeng@sjtu.edu.cn   
Principal Investigator: Jingyi Xu, MD         
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Institute of Antibiotics, Huashan Hospital, Fudan University
Investigators
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Study Director: Feng Ding, PhD Division of Nephrology,Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University

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Responsible Party: Ding Feng, Kidney internal medicine professor, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT03714789     History of Changes
Other Study ID Numbers: PKDialysis-201710
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ding Feng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
Kidney Failure
Pharmacokinetics
Antibiotics
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Dialysis Solutions
Anti-Infective Agents
Antitubercular Agents
Pharmaceutical Solutions