Sample Collection, Biobanking, and Analysis

Ahsman, Maurice J.; Tibboel, Dick; Mathôt, Ron A. A.; Wildt, Saskia N. de

doi:10.1007/978-3-642-20195-0_10

Cited by 5 publications

(7 citation statements)

References 55 publications

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“…Pharmacokinetic study with drug already prescribed to patient [70] No potential benefit to patient. Multiple catheter accesses may increase risk of infection.…”

Section: Resultsmentioning

confidence: 99%

“…Opportunistic studies determine levels of the drug received as part of the patient's treatment and no study drug is given [71]. Another strategy is to measure drug concentration in blood left over from routine analysis [70,71]. Population PK makes use of randomly collected and limited blood samples per patient.…”

Section: Opportunistic or Sparse Blood Sampling Methodsmentioning

confidence: 99%

“…To avoid accessing lines just for research purposes, sampling for research purposes can be combined with regular blood work. In the absence of a line, samples can be collected during routine heel pricks [70]. Opportunistic studies determine levels of the drug received as part of the patient's treatment and no study drug is given [71].…”

Section: Opportunistic or Sparse Blood Sampling Methodsmentioning

confidence: 99%

“…High performance liquid (LC-MS) or gas (GC-MS) chromatography allows simultaneous analyses of many low-concentration substances in small plasma volumes (10-100 lL) or leftovers [70,73]. This is of particular interest for studies in neonates and small children, whose total blood volume is small [71].…”

Section: Low Volume Drug Assaysmentioning

confidence: 99%

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Ethics of Drug Research in the Pediatric Intensive Care Unit

et al. 2014

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Critical illness and treatment modalities change pharmacokinetics and pharmacodynamics of medications used in critically ill children, in addition to age-related changes in drug disposition and effect. Hence, to ensure effective and safe drug therapy, research in this population is urgently needed. However, conducting research in the vulnerable population of the pediatric intensive care unit (PICU) presents with ethical challenges. This article addresses the main ethical issues specific to drug research in these critically ill children and proposes several solutions. The extraordinary environment of the PICU raises specific challenges to the design and conduct of research. The need for proxy consent of parents (or legal guardians) and the stress-inducing physical environment may threaten informed consent. The informed consent process is challenging because emergency research reduces or even eliminates the time to seek consent. Moreover, parental anxiety may impede adequate understanding and generate misconceptions. Alternative forms of consent have been developed taking into account the unpredictable reality of the acute critical care environment. As with any research in children, the burden and risk should be minimized. Recent developments in sample collection and analysis as well as pharmacokinetic analysis should be considered in the design of studies. Despite the difficulties inherent to drug research in critically ill children, methods are available to conduct ethically sound research resulting in relevant and generalizable data. This should motivate the PICU community to commit to drug research to ultimately provide the right drug at the right dose for every individual child.

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“…Pharmacokinetic study with drug already prescribed to patient [70] No potential benefit to patient. Multiple catheter accesses may increase risk of infection.…”

Section: Resultsmentioning

confidence: 99%

Section: Opportunistic or Sparse Blood Sampling Methodsmentioning

confidence: 99%

Section: Opportunistic or Sparse Blood Sampling Methodsmentioning

confidence: 99%

Section: Low Volume Drug Assaysmentioning

confidence: 99%

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Ethics of Drug Research in the Pediatric Intensive Care Unit

et al. 2014

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“…This enables the construction of PK models with limited and random patient samples .Using these techniques routine collection of blood samples in combination with registration of clinical and dose information in a patient data management system (PDMS) would improve the availability of data for these analyses. By analyzing samples in such a biobank, it might be possible to get enough samples to model these drugs and their metabolites as well, so that proper dose regimens can be constructed [115]. Perhaps the number of samples might be increased in future by using leftover material from routine clinical chemistry measurements using LC-MS.…”

Section: Future Perspectivesmentioning

confidence: 99%

Pharmacotherapy in Neonatal and Pediatric Extracorporeal Membrane Oxygenation (ECMO)

Wildschut

Ahsman²,

Houmes³

et al. 2012

CDM

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ECMO support is an established life saving therapy for potentially reversible respiratory and/or cardiac failure. Improvement of outcome depends on effective treatment of the primary diagnosis and complications. Adequate drug therapy is important in reaching these goals. Pharmacokinetic and pharmacodynamic data in neonates and older children on ECMO are sparse. Most studies show altered volume of distribution and clearance for the drugs studied. This article gives an overview of the available PK and PD studies in neonates and children on ECMO, suggests possible mechanisms of altered PK and PD and identifies areas of interest for further research.

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