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OpenTrials
Completed

NCT Number: NCT03685747

Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Vancomycin

Drug

Vancomycin one-time 20 mg/kg intraperitoneal dose.

Primary outcomes

  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-inf)

    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 outcomes

  1. Adverse Events

    Time frame: Days: 1-7

    Any adverse events throughout entirety of study as assessed by physician-investigator

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

A Prospective, Single-site, Open-label, Pharmacokinetic Study of Intermittent Intraperitoneal Vancomycin in Adult Subjects Receiving Automated Peritoneal Dialysis

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2018
Registry last updated
Mar 3, 2022

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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