Altered gentamicin pharmacokinetics in term neonates undergoing controlled hypothermia

British Journal of Clinical Pharmacology

Volumn 81, Issue 6, 2016, Pages 1067-1077

  Bijleveld, Yuma A ^a   De Haan, Timo R ^b   Van Der Lee, Hanneke J H ^c   Groenendaal, Floris ^d   Dijk, Peter H ^e   Van Heijst, Arno ^f   De Jonge, Rogier C J ^g   Dijkman, Koen P ^h   Van Straaten, Henrica L M ⁱ   Rijken, Monique ^j   Zonnenberg, Inge A ^k   Cools, Filip ^l   Zecic, Alexandra ^m   Nuytemans, Debbie H G M ⁿ   Van Kaam, Anton H ^b   Mathot, Ron A A ^a   Brouwer, Mieke J ^d   Van Den Broek, Marcel P ^d   Rademaker, Carin M A ^d   Liem, Djien ^f   Steiner, Katerna ^f   Simons, Sinno H P ^g   Bos, Annelies A ^g   Mulder De Tollenaer, S M ⁱ   Groot Jebbink Akkerman, L J M ⁱ   Sonnaert, Michel ^l   Camfferman, Fleur Anne ^l   more..

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b EMMA CHILDREN S HOSPITAL   (Netherlands)

^c UNIVERSITY OF AMSTERDAM   (Netherlands)

^d UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^e UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^f RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^g SOPHIA CHILDREN S HOSPITAL   (Netherlands)

^h MÁXIMA MEDICAL CENTER   (Netherlands)

ⁱ ISALA HOSPITAL   (Netherlands)

^j LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^k VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^l VRIJE UNIVERSITEIT BRUSSEL   (Belgium)

^m Academic Medical Center   (Belgium)

ⁿ Clinical Research Coordinator PharmaCool Study   (Belgium)

more..

Author keywords

controlled hypothermia; gentamicin; neonates; population pharmacokinetics

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CREATININE; GENTAMICIN; UREA; ANTIINFECTIVE AGENT;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BODY TEMPERATURE; CLINICAL ARTICLE; COHORT ANALYSIS; COMPARTMENT MODEL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DRUG BLOOD LEVEL; DRUG EFFECT; FEMALE; GESTATIONAL AGE; HUMAN; HYPOTHERMIA; HYPOXIC ISCHEMIC ENCEPHALOPATHY; MALE; MULTICENTER STUDY; NEWBORN; OBSERVATIONAL STUDY; PERINATAL ASPHYXIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; UREA BLOOD LEVEL; URINE VOLUME; VOLUME OF DISTRIBUTION; WARMING; CLINICAL TRIAL; COMPUTER SIMULATION; FETUS HYPOXIA; INDUCED HYPOTHERMIA; STATISTICAL MODEL;

ANTI-BACTERIAL AGENTS; COHORT STUDIES; COMPUTER SIMULATION; FEMALE; FETAL HYPOXIA; GENTAMICINS; GESTATIONAL AGE; HUMANS; HYPOTHERMIA, INDUCED; HYPOXIA-ISCHEMIA, BRAIN; INFANT, NEWBORN; MALE; MODELS, STATISTICAL; PROSPECTIVE STUDIES; REWARMING;

EID: 84960157521     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12883     Document Type: Article

References (31)

1. Groenendaal F, Casaer A, Dijkman KP, Gavilanes AW, de Haan TR, ter Horst HJ, Laroche S, Naulaers G, Rijken M, van Straaten HL, Steiner K, Swarte RM, Zecic A, Zonnenberg IA,. Introduction of hypothermia for neonates with perinatal asphyxia in The Netherlands and Flanders. Neonatology 2013; 104: 15-21.
2. Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG,. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev 2013; 1: CD003311.
3. Guignard JP, Gillieron P,. Effect of modest hypothermia on the immature kidney. Acta Paediatr 1997; 86: 1040-1.
4. Smit E, Liu X, Gill H, Sabir H, Jary S, Thoresen M,. Factors associated with permanent hearing impairment in infants treated with therapeutic hypothermia. J Pediatr 2013; 163: 995-1000.
5. Liu X, Borooah M, Stone J, Chakkarapani E, Thoresen M,. Serum gentamicin concentrations in encephalopathic infants are not affected by therapeutic hypothermia. Pediatrics 2009; 124: 310-5.
6. Mark LF, Solomon A, Northington FJ, Lee CK,. Gentamicin pharmacokinetics in neonates undergoing therapeutic hypothermia. Ther Drug Monit 2013; 35: 217-22.
7. Frymoyer A, Meng L, Bonifacio SL, Verotta D, Guglielmo BJ,. Gentamicin pharmacokinetics and dosing in neonates with hypoxic ischemic encephalopathy receiving hypothermia. Pharmacotherapy 2013; 33: 718-26.
8. de Haan TR, Bijleveld YA, van der Lee JH, Groenendaal F, van den Broek MP, Rademaker CM, van Straaten HL, van Weissenbruch MM, Vermeulen JR, Dijk PH, Dudink J, Rijken M, van HA, Dijkman KP, Gavilanes D, van Kaam AH, Offringa M, Mathot RA,. Pharmacokinetics and pharmacodynamics of medication in asphyxiated newborns during controlled hypothermia. The PharmaCool multicenter study. BMC Pediatr 2012; 12: 45.
9. Stichting Nederlands Kenniscentrum voor Farmacotherapie bij Kinderen (NKFK): Het Kinderformularium; 2015.
10. Bijleveld Y, de HT, Toersche J, Jorjani S, van der Lee J, Groenendaal F, Dijk P, van HA, Gavilanes AW, Dijkman KP, van SH, Rijken M, Zonnenberg I, Cools F, Nuytemans D, Mathot R,. A simple quantitative method analysing amikacin, gentamicin, and vancomycin levels in human newborn plasma using ion-pair liquid chromatography/tandem mass spectrometry and its applicability to a clinical study. J Chromatogr B Analyt Technol Biomed Life Sci 2014; 951-952: 110-8.
11. Jonsson EN, Karlsson MO,. Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed 1999; 58: 51-64.
12. Lindbom L, Pihlgren P, Jonsson EN,. PsN-toolkit-a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed 2005; 79: 241-57.
13. Mould DR, Upton RN,. Basic concepts in population modeling, simulation, and model-based drug development-part 2: introduction to pharmacokinetic modeling methods. CPT Pharmacometrics Syst Pharmacol 2013; 2: e38.
14. Holford NH,. A size standard for pharmacokinetics. Clin Pharmacokinet 1996; 30: 329-32.
15. Savic RM, Karlsson MO,. Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. AAPS J 2009; 11: 558-69.
16. Shah PS, Beyene J, To T, Ohlsson A, Perlman M,. Postasphyxial hypoxic-ischemic encephalopathy in neonates: outcome prediction rule within 4 hours of birth. Arch Pediatr Adolesc Med 2006; 160: 729-36.
17. Rhodin MM, Anderson BJ, Peters AM, Coulthard MG, Wilkins B, Cole M, Chatelut E, Grubb A, Veal GJ, Keir MJ, Holford NH,. Human renal function maturation: a quantitative description using weight and postmenstrual age. Pediatr Nephrol 2009; 24: 67-76.
18. Holford N, Heo YA, Anderson B,. A pharmacokinetic standard for babies and adults. J Pharm Sci 2013; 102: 2941-52.
19. Brendel K, Comets E, Laffont C, Laveille C, Mentre F,. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res 2006; 23: 2036-49.
20. Moore RD, Lietman PS, Smith CR,. Clinical response to aminoglycoside therapy: importance of the ratio of peak concentration to minimal inhibitory concentration. J Infect Dis 1987; 155: 93-9.
21. Bastone EB, Li SC, Ioannides-Demos LL, Spicer WJ, McLean AJ,. Kill kinetics and regrowth patterns of Escherichia coli exposed to gentamicin concentration-time profiles simulating in vivo bolus and infusion dosing. Antimicrob Agents Chemother 1993; 37: 914-7.
22. Allegaert K, Anderson BJ, van den Anker JN, Vanhaesebrouck S, de ZF,. Renal drug clearance in preterm neonates: relation to prenatal growth. Ther Drug Monit 2007; 29: 284-91.
23. Leake RD, Trygstad CW, Oh W,. Inulin clearance in the newborn infant: relationship to gestational and postnatal age. Pediatr Res 1976; 10: 759-62.
24. Fuchs A, Guidi M, Giannoni E, Werner D, Buclin T, Widmer N, Csajka C,. Population pharmacokinetic study of gentamicin in a large cohort of premature and term neonates. Br J Clin Pharmacol 2014; 78: 1090-101.
25. Nielsen EI, Sandstrom M, Honore PH, Ewald U, Friberg LE,. Developmental pharmacokinetics of gentamicin in preterm and term neonates: population modelling of a prospective study. Clin Pharmacokinet 2009; 48: 253-63.
26. De Cock RF, Allegaert K, Sherwin CM, Nielsen EI, de HM, van den Anker JN, Danhof M, Knibbe CA,. A neonatal amikacin covariate model can be used to predict ontogeny of other drugs eliminated through glomerular filtration in neonates. Pharm Res 2014; 31: 754-67.
27. De Cock RF, Allegaert K, Schreuder MF, Sherwin CM, de HM, van den Anker JN, Danhof M, Knibbe CA,. Maturation of the glomerular filtration rate in neonates, as reflected by amikacin clearance. Clin Pharmacokinet 2012; 51: 105-17.
28. Lanao JM, Calvo MV, Mesa JA, Martin-Suarez A, Carbajosa MT, Miguelez F, Dominguez-Gil A,. Pharmacokinetic basis for the use of extended interval dosage regimens of gentamicin in neonates. J Antimicrob Chemother 2004; 54: 193-8.
29. Stolk LM, Degraeuwe PL, Nieman FH, de Wolf MC, de BA,. Population pharmacokinetics and relationship between demographic and clinical variables and pharmacokinetics of gentamicin in neonates. Ther Drug Monit 2002; 24: 527-31.
30. DiCenzo R, Forrest A, Slish JC, Cole C, Guillet R,. A gentamicin pharmacokinetic population model and once-daily dosing algorithm for neonates. Pharmacotherapy 2003; 23: 585-91.
31. Frymoyer A, Lee S, Bonifacio SL, Meng L, Lucas SS, Guglielmo BJ, Sun Y, Verotta D,. Every 36-h gentamicin dosing in neonates with hypoxic-ischemic encephalopathy receiving hypothermia. J Perinatol 2013; 33: 778-82.