Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 3/24/2019 |
| Start Date: | November 15, 2018 |
| End Date: | August 2019 |
| Contact: | Edwin Lam, PharmD |
| Email: | edwin.lam@jefferson.edu |
| Phone: | 215-955-9076 |
A Prospective, Single-site, Open-label, Pharmacokinetic Study of Intermittent Intraperitoneal Vancomycin in Adult Subjects Receiving Automated 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.
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.
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.
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.
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
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