title: Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative.
abstract: The effect of AKI and modern continuous RRT (CRRT) methods on drug disposition (pharmacokinetics) and response has been poorly studied. Pharmaceutical manufacturers have little incentive to perform pharmacokinetic studies in patients undergoing CRRT because such studies are neither recommended in existing US Food and Drug Administration (FDA) guidance documents nor required for new drug approval. Action is urgently needed to address the knowledge deficit. The Kidney Health Initiative has assembled a work group composed of clinicians and scientists representing academia, the FDA, and the pharmaceutical and dialysis industries with expertise related to pharmacokinetics, AKI, and/or CRRT. The work group critically evaluated key considerations in the assessment of pharmacokinetics and drug dosing in CRRT, practical constraints related to conducting pharmacokinetic studies in critically ill patients, and the generalizability of observations made in the context of specific CRRT prescriptions and specific patient populations in order to identify efficient study designs capable of addressing the knowledge deficit without impeding drug development. Considerations for the standardized assessment of pharmacokinetics and development of corresponding drug dosing recommendations in critically ill patients with AKI receiving CRRT are proposed.
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material. nolin@pitt.edu.
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Nolin
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: George R
authors.initials: GR
authors.lastname: Aronoff
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: William H
authors.initials: WH
authors.lastname: Fissell
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Lokesh
authors.initials: L
authors.lastname: Jain
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Rajnikanth
authors.initials: R
authors.lastname: Madabushi
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Kellie
authors.initials: K
authors.lastname: Reynolds
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Lei
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Shiew Mei
authors.initials: SM
authors.lastname: Huang
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Rajnish
authors.initials: R
authors.lastname: Mehrotra
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Flessner
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: John K
authors.initials: JK
authors.lastname: Leypoldt
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Jennifer W
authors.initials: JW
authors.lastname: Witcher
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Issam
authors.initials: I
authors.lastname: Zineh
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Patrick
authors.initials: P
authors.lastname: Archdeacon
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Prabir
authors.initials: P
authors.lastname: Roy-Chaudhury
authors.affiliation: Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
authors.forename: Stuart L
authors.initials: SL
authors.lastname: Goldstein
mesh_terms: D058186:Acute Kidney Injury / Q000175:diagnosis / Q000378:metabolism / Q000628:therapy*; D016638:Critical Illness; D054796:Drug Dosage Calculations; D006801:Humans; D009398:Nephrology / Q000379:methods / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000378:metabolism*; D010599:Pharmacokinetics; D017582:Renal Replacement Therapy / Q000009:adverse effects
chemical_list: D004364:Pharmaceutical Preparations
keywords: acute renal failure; dialysis; pharmacokinetic