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Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis

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ClinicalTrials.gov Identifier: NCT03685747
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Walter K. Kraft, Thomas Jefferson University

Brief Summary:
Vancomycin is the most commonly used empiric treatment for infectious peritonitis in patients on peritoneal dialysis. Current dosing and monitoring for safety and efficacy is empiric, especially for those on rapid-cycling modalities. The goal of this study is to understand the pharmacokinetics of vancomycin in patients on rapid-cycling peritoneal dialysis modalities in order to derive an optimal dosing regimen.

Condition or disease Intervention/treatment Phase
Peritoneal Dialysis-associated Peritonitis Drug: Vancomycin Phase 1

Detailed Description:

Peritoneal dialysis (PD) is a form of renal replacement therapy indicated for those with acute kidney injury or end stage renal disease. Currently, two modalities of PD exist and is individualized based on patient and life-style specific factors. Continuous ambulatory peritoneal dialysis (CAPD) allows 4 - 5 exchanges performed manually whereas automated peritoneal dialysis (APD) involves continuous, automated, cyclical exchanges performed by a device at home during the night. Peritonitis is a common complication in PD and accounts for a large portion of hospital readmission and mortality. Vancomycin is the most common antibiotic recommended and has notable gram-positive coverage used empirically during suspected peritonitis.

Despite widespread use, vancomycin lacks good pharmacokinetic characterization in PD. Early pharmacokinetic studies using vancomycin were conducted predominantly in patients on CAPD on glucose-based prescriptions. Data is non-existent in PD patients administered the novel dialysate solution icodextrin, or those treated with overnight APD. The impact of residual kidney function (RKF) on vancomycin in PD is also lacking. Enhanced vancomycin clearance in RKF may result in under-dosing, while overdosing may result in nephrotoxicity and loss of clinically important RKF.

The investigators will characterize the pharmacokinetic profile of vancomycin following a single intraperitoneal dose of vancomycin in icodextrin dialysate to non-infected PD patients and examine the relationship between RKF and vancomycin clearance using serum, dialysate and urine. The goal is to use this data in non-infected subjects to generate information to guide vancomycin dosing in patients on rapid-cycling PD modalities.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Prospective, Single-site, Open-label, Pharmacokinetic Study of Intermittent Intraperitoneal Vancomycin in Adult Subjects Receiving Automated Peritoneal Dialysis
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Vancomycin
A single 20 mg/kg intraperitoneal dose in 1-liter of 7.5% icodextrin solution of vancomycin will be administered. Sparse blood sampling will be obtained during an overnight 12-hour dwell and during the exchange period.
Drug: Vancomycin
Vancomycin one-time 20 mg/kg intraperitoneal dose.




Primary Outcome Measures :
  1. Maximum total plasma concentration (Cmax) [ Time Frame: Day: 1 ]
    Total systemic plasma concentration following 12-hour dwell

  2. Time to maximum plasma concentration (Tmax) [ Time Frame: Day: 1 ]
    Time (hours) to achieve the maximum plasma concentration

  3. Area under the concentration-time curve (AUC0-T) [ Time Frame: Days: 1-7 ]
    AUC based on vancomycin plasma concentrations

  4. Total body clearance (CLtotal) [ Time Frame: Days: 1-7 ]
    Total vancomycin plasma vancomycin clearance

  5. Dialytic Clearance [ Time Frame: Days: 1-7 ]
    Vancomycin clearance from peritoneal dialysis


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Days: 1-7 ]
    Any adverse events throughout entirety of study as assessed by physician-investigator



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Adult male or females between 18 - 85 years old
  • Stabilized on a PD regimen for > 3 months prior to study initiation

Exclusion Criteria:

  • Clinically significant disease unrelated to renal impairment or deemed unfit by the investigator
  • Allergy or hypersensitivity to vancomycin or icodextrin-containing dialysis solution
  • Active peritonitis infection
  • Previous intraperitoneal antibiotic treatment within 2 months
  • Previous intravenous vancomycin treatment within 2 months
  • Hemoglobin < 9 g/dL
  • Pregnant or breast-feeding women

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): NCT03685747


Contacts
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Contact: Edwin Lam, PharmD 215-955-9076 edwin.lam@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jingjing Zhang, MD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Walter K Kraft, MD Thomas Jefferson University

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Responsible Party: Walter K. Kraft, Clinical Research Unit Medical Director, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03685747     History of Changes
Other Study ID Numbers: 12451
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Walter K. Kraft, Thomas Jefferson University:
Vancomycin
Pharmacokinetics
Pharmacodynamics
Automated Peritoneal Dialysis
Additional relevant MeSH terms:
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Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents