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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | Vancomycin one-time 20 mg/kg intraperitoneal dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Total Plasma Concentration (Cmax) | Total systemic plasma concentration following 12-hour dwell | Day: 1 |
| Time to Maximum Plasma Concentration (Tmax) | Time (hours) to achieve the maximum plasma concentration | Day: 1 |
| Area Under the Concentration-time Curve (AUC0-inf) | AUC based on vancomycin plasma concentrations | Days: 1-7 |
| Total Body Clearance (CLtotal) | Total vancomycin plasma vancomycin clearance | Days: 1-7 |
| Dialytic Clearance | Vancomycin clearance from peritoneal dialysis | Days: 1-7 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Any adverse events throughout entirety of study as assessed by physician-investigator | Days: 1-7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter K Kraft, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34755479 | Result | Lam E, Ting Kayla Lien Y, Kraft WK, Stickle DF, Piraino B, Zhang J. Intraperitoneal pharmacokinetics of vancomycin in patients on automated peritoneal dialysis. Clin Transl Sci. 2022 Mar;15(3):649-657. doi: 10.1111/cts.13182. Epub 2021 Nov 9. |
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Individual level PK de-identified data maybe shared
through 2024
email. walter.kraft@jefferson.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Total Plasma Concentration (Cmax) | Total systemic plasma concentration following 12-hour dwell | Posted | Mean | Standard Deviation | mg/L | Day: 1 |
|
|
10 days
Subjects were assessed daily for adverse events till day 7 and then again on day 10 post study visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Vancomycin: Vancomycin one-time 20 mg/kg intraperitoneal dose. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Walter Kraft | Thomas Jefferson University | 2159559077 | walter.kraft@jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2019 | Dec 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Time to Maximum Plasma Concentration (Tmax) | Time (hours) to achieve the maximum plasma concentration | Posted | Median | Full Range | hours | Day: 1 |
|
|
|
| Primary | Area Under the Concentration-time Curve (AUC0-inf) | AUC based on vancomycin plasma concentrations | Posted | Mean | Standard Deviation | hr x mg/L | Days: 1-7 |
|
|
|
| Primary | Total Body Clearance (CLtotal) | Total vancomycin plasma vancomycin clearance | Posted | Mean | Standard Deviation | mL/min | Days: 1-7 |
|
|
|
| Primary | Dialytic Clearance | Vancomycin clearance from peritoneal dialysis | Posted | Mean | Standard Deviation | mL/min | Days: 1-7 |
|
|
|
| Secondary | Adverse Events | Any adverse events throughout entirety of study as assessed by physician-investigator | Posted | Count of Participants | Participants | Days: 1-7 |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |