Document Detail


Population pharmacokinetics of piperacillin using scavenged samples from preterm infants.
MedLine Citation:
PMID:  22569355     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: Piperacillin is often used in preterm infants for intra-abdominal infections; however, dosing has been derived from small single-center studies excluding extremely preterm infants at a highest risk for these infections. We evaluated the population pharmacokinetics (PK) of piperacillin using targeted sparse sampling and scavenged samples obtained from preterm infants ≤ 32 weeks of gestational age at birth and <120 postnatal days.
MATERIALS AND METHODS: A 5-center study was performed. A population PK model using nonlinear mixed effect modeling was developed. Covariate effects were evaluated based on the estimated precision and clinical significance.
RESULTS: Fifty-six preterm infants were evaluated and had a median (range) gestational age at birth of 25 (22-32) weeks, a postnatal age of 17 (1-77) days, a postmenstrual age of 29 (23-40) weeks, and a weight of 867 (400-2580) g. The final PK data set contained 211 samples; 202/211 (96%) were scavenged from the discarded clinical specimens. Piperacillin population PK was best described by a 1-compartment model. The population mean clearance (CL) was derived by the equation CL (L/h) = 0.479 × (weight)(0.75) × 0.5/serum creatinine and using a volume of distribution (V) (L) of 2.91 × (weight). The relative standard errors around parameter estimates ranged from 13.7% to 32.2%. A trend toward increased CL was observed with increasing gestational age at birth; infants with serum creatinine ≥ 1.2 mg/dL had a 60% reduction in piperacillin CL. The majority (>70%) of infants did not meet predefined pharmacodynamic efficacy targets.
CONCLUSIONS: Scavenged PK sampling is a minimal-risk approach that can provide meaningful information related to the development of PK models but not dosing recommendations for piperacillin. The utility of scavenged sampling in providing definitive dosing recommendations may be drug dependent and needs to be further explored.
Authors:
Michael Cohen-Wolkowiez; Daniel K Benjamin; Ashley Ross; Laura P James; Janice E Sullivan; Michele C Walsh; Arlene Zadell; Nancy Newman; Nicole R White; Angela D M Kashuba; Daniele Ouellet
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Therapeutic drug monitoring     Volume:  34     ISSN:  1536-3694     ISO Abbreviation:  Ther Drug Monit     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-05-16     Completed Date:  2013-03-11     Revised Date:  2013-06-25    
Medline Journal Info:
Nlm Unique ID:  7909660     Medline TA:  Ther Drug Monit     Country:  United States    
Other Details:
Languages:  eng     Pagination:  312-9     Citation Subset:  IM    
Affiliation:
Department of Pediatrics, Duke University, Durham, North Carolina 27715, USA. michael.cohenwolkowiez@duke.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00873327
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MeSH Terms
Descriptor/Qualifier:
Anti-Bacterial Agents / blood*,  pharmacokinetics
Blood Specimen Collection / methods*
Computer Simulation
Female
Gestational Age
Humans
Infant, Newborn
Infant, Premature / blood*
Male
Models, Chemical
Piperacillin / blood*,  pharmacokinetics
Prospective Studies
Grant Support
ID/Acronym/Agency:
K23 HD064814/HD/NICHD NIH HHS; K24 HD058735/HD/NICHD NIH HHS; P30 AI050410/AI/NIAID NIH HHS; UL1 RR029884/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; 61477-96-1/Piperacillin
Comments/Corrections

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