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
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Dialysis-associated Peritonitis||Drug: Vancomycin||Phase 1|
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.
|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|
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.
Vancomycin one-time 20 mg/kg intraperitoneal dose.
- Maximum total plasma concentration (Cmax) [ Time Frame: Day: 1 ]Total systemic plasma concentration following 12-hour dwell
- Time to maximum plasma concentration (Tmax) [ Time Frame: Day: 1 ]Time (hours) to achieve the maximum plasma concentration
- Area under the concentration-time curve (AUC0-T) [ Time Frame: Days: 1-7 ]AUC based on vancomycin plasma concentrations
- Total body clearance (CLtotal) [ Time Frame: Days: 1-7 ]Total vancomycin plasma vancomycin clearance
- Dialytic Clearance [ Time Frame: Days: 1-7 ]Vancomycin clearance from peritoneal dialysis
- Adverse events [ Time Frame: Days: 1-7 ]Any adverse events throughout entirety of study as assessed by physician-investigator
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
|Contact: Edwin Lam, PharmDemail@example.com|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Jingjing Zhang, MD|
|Principal Investigator:||Walter K Kraft, MD||Thomas Jefferson University|