Renal Function Descriptors in Neonates: Which Creatinine-Based Formula Best Describes Vancomycin Clearance?

Journal of Clinical Pharmacology

Volumn 56, Issue 5, 2016, Pages 528-540

  Bhongsatiern, Jiraganya ^a   Stockmann, Chris ^b,c   Yu, Tian ^b   Constance, Jonathan E ^b   Moorthy, Ganesh ^a   Spigarelli, Michael G ^b,c   Desai, Pankaj B ^a   Sherwin, Catherine M T ^b,c  

^a UNIVERSITY OF CINCINNATI   (United States)

^b UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF UTAH   (United States)

Author keywords

infectious diseases; neonatology; nephrology; population pharmacokinetics; special populations

Indexed keywords

CREATININE; VANCOMYCIN; ANTIINFECTIVE AGENT;

DATA ANALYSIS; DRUG CLEARANCE; DRUG EXCRETION; GLOMERULUS FILTRATION RATE; HUMAN; KIDNEY FUNCTION; NEWBORN ASSESSMENT; PREDICTOR VARIABLE; PREMATURITY; REVIEW; URINARY EXCRETION; BLOOD; KIDNEY; METABOLIC CLEARANCE RATE; METABOLISM; NEWBORN; PHYSIOLOGY;

ANTI-BACTERIAL AGENTS; CREATININE; GLOMERULAR FILTRATION RATE; HUMANS; INFANT, NEWBORN; KIDNEY; METABOLIC CLEARANCE RATE; VANCOMYCIN;

EID: 84951760861     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.650     Document Type: Review

References (99)

1. Allegaert K, van den Anker JN,. Clinical pharmacology in neonates: small size, huge variability. Neonatology. 2014; 105 (4): 344-349.
2. Rodriguez MM, Gomez AH, Abitbol CL, Chandar JJ, Duara S, Zilleruelo GE,. Histomorphometric analysis of postnatal glomerulogenesis in extremely preterm infants. Pediatr Dev Pathol. 2004; 7 (1): 17-25.
3. Solhaug MJ, Bolger PM, Jose PA,. The developing kidney and environmental toxins. Pediatrics. 2004; 113 (4 Suppl): 1084-1091.
4. American Academy of Pediatrics. Staphylococcal infections. In:, Pickering LK, Baker CJ, Kimberlin DW, Long SS, eds. Red Book 2012 Report of the Committee on Infectious Diseases. 29 ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012: 652-821.
5. Mehrotra N, Tang L, Phelps SJ, Meibohm B,. Evaluation of vancomycin dosing regimens in preterm and term neonates using Monte Carlo simulations. Pharmacotherapy. 2012; 32 (5): 408-419.
6. Allegaert K, Anderson BJ, van den Anker JN, Vanhaesebrouck S, de Zegher F,. Renal drug clearance in preterm neonates: relation to prenatal growth. Ther Drug Monit. 2007; 29 (3): 284-291.
7. Anderson BJ, Allegaert K, Van den Anker JN, Cossey V, Holford NH,. Vancomycin pharmacokinetics in preterm neonates and the prediction of adult clearance. Br J Clin Pharmacol. 2007; 63 (1): 75-84.
8. Kimura T, Sunakawa K, Matsuura N, Kubo H, Shimada S, Yago K,. Population pharmacokinetics of arbekacin, vancomycin, and panipenem in neonates. Antimicrob Agents Chemother. 2004; 48 (4): 1159-1167.
9. Capparelli EV, Lane JR, Romanowski GL, et al., The influences of renal function and maturation on vancomycin elimination in newborns and infants. J Clin Pharmacol. 2001; 41 (9): 927-934.
10. Grimsley C, Thomson AH,. Pharmacokinetics and dose requirements of vancomycin in neonates. Arch Dis Child Fetal Neonatal Ed. 1999; 81 (3): F221-F227.
11. Zhao W, Kaguelidou F, Biran V, et al., External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings. Br J Clin Pharmacol. 2012; 75 (4): 1068-1080.
12. De Cock RF, Allegaert K, Brussee JM, et al., Simultaneous pharmacokinetic modeling of gentamicin, tobramycin and vancomycin clearance from neonates to adults: towards a semi-physiological function for maturation in glomerular filtration. Pharm Res. 2014; 31 (10): 2643-2654.
13. De Cock RF, Allegaert K, Sherwin CM, et al., A neonatal amikacin covariate model can be used to predict ontogeny of other drugs eliminated through glomerular filtration in neonates. Pharm Res. 2014; 31 (3): 754-767.
14. Irikura M, Fujiyama A, Saita F, et al., Evaluation of the vancomycin dosage regimen based on serum creatinine used in the neonatal intensive care unit. Pediatr Int. 2011; 53 (6): 1038-1044.
15. Horster MF, Braun GS, Huber SM,. Embryonic renal epithelia: induction, nephrogenesis, and cell differentiation. Physiol Rev. 1999; 79 (4): 1157-1191.
16. Sulemanji M, Vakili K,. Neonatal renal physiology. Semin Pediatr Surg. 2013; 22 (4): 195-198.
17. Saxen L, Sariola H,. Early organogenesis of the kidney. Pediatr Nephrol. 1987; 1 (3): 385-392.
18. Saxen L., Failure to demonstrate tubule induction in a heterologous mesenchyme. Develop Biol. 1970; 23 (4): 511-523.
19. Jose PA, Fildes RD, Gomez RA, Chevalier RL, Robillard JE,. Neonatal renal function and physiology. Curr Opin Pediatr. 1994; 6 (2): 172-177.
20. Aperia A, Broberger O, Elinder G, Herin P, Zetterstrom R,. Postnatal development of renal function in pre-term and full-term infants. Acta Paediatr Scand. 1981; 70 (2): 183-187.
21. Rudolph AM, Heymann MA,. The fetal circulation. Annu Rev Med. 1968; 19: 195-206.
22. Musso CG, Ghezzi L, Ferraris J,. Renal physiology in newborns and old people: similar characteristics but different mechanisms. Int Urol Nephrol. 2004; 36 (2): 273-276.
23. Rubin MI, Bruck E, Rapoport M,. Maturation of renal function in childhood; clearance studies. J Clin Invest. 1949; 28 (5 Pt 2): 1144-1162.
24. Guignard JP., Postnatal development of glomerular filtration rate in neonates. In:, Polin RA, Fox W, Abman SH, eds. Fetal and Neonatal Physiology, 3rd ed. Philadelphia: Elsevier Saunders; 2004: 1256-1266.
25. Hentschel R, Lodige B, Bulla M,. Renal insufficiency in the neonatal period. Clin Nephrol. 1996; 46 (1): 54-58.
26. Toth-Heyn P, Drukker A, Guignard JP,. The stressed neonatal kidney: from pathophysiology to clinical management of neonatal vasomotor nephropathy. Pediatr Nephrol. 2000; 14 (3): 227-239.
27. Levick JR., Revision of the Starling principle: new views of tissue fluid balance. J Physiol. 2004; 557 (Pt 3): 704.
28. Schwartz GJ, Munoz A, Schneider MF, et al., New equations to estimate GFR in children with CKD. J Am Soc Nephrol. 2009; 20 (3): 629-637.
29. Gheissari A, Naseri F, Pourseirafi H, Merrikhi A,. Postnatal kidney function in children born very low birth weight. Iran J Kidney Dis. 2012; 6 (4): 256-261.
30. Iacobelli S, Loprieno S, Bonsante F, Latorre G, Esposito L, Gouyon JB,. Renal function in early childhood in very low birthweight infants. Am J Perinatol. 2007; 24 (10): 587-592.
31. Guignard JP, John EG,. Renal function in the tiny, premature infant. Clin Perinatol. 1986; 13 (2): 377-401.
32. Quigley R., Developmental changes in renal function. Curr Opin Pediatr. 2012; 24 (2): 184-190.
33. Zarowitz BJ, Robert S, Peterson EL,. Prediction of glomerular filtration rate using aminoglycoside clearance in critically ill medical patients. Ann Pharmacother. 1992; 26 (10): 1205-1210.
34. Koren G, James A, Perlman M,. A simple method for the estimation of glomerular filtration rate by gentamicin pharmacokinetics during routine drug monitoring in the newborn. Clin Pharmacol Ther. 1985; 38 (6): 680-685.
35. De Cock RF, Allegaert K, Schreuder MF, et al., Maturation of the glomerular filtration rate in neonates, as reflected by amikacin clearance. Clin Pharmacokinet. 2012; 51 (2): 105-117.
36. Jacobs RF, Kearns GL, Brown AL, Trang JM, Kluza RB,. Renal clearance of imipenem in children. Eur J Clin Microbiol. 1984; 3 (5): 471-474.
37. Fernandez E, Perez R, Hernandez A, Tejada P, Arteta M, Ramos JT,. Factors and mechanisms for pharmacokinetic differences between pediatric population and adults. Pharmaceutics. 2011; 3 (1): 53-72.
38. Filler G, Browne R, Seikaly MG,. Glomerular filtration rate as a putative "surrogate end-point" for renal transplant clinical trials in children. Pediatr Transplant. 2003; 7 (1): 18-24.
39. Levey AS, Coresh J, Balk E, et al., National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med. 2003; 139 (2): 137-147.
40. Askenazi DJ, Ambalavanan N, Goldstein SL,. Acute kidney injury in critically ill newborns: what do we know? What do we need to learn? Pediatr Nephrol. 2009; 24 (2): 265-274.
41. Bueva A, Guignard JP,. Renal function in preterm neonates. Pediatr Res. 1994; 36 (5): 572-577.
42. Schwartz GJ, Furth S, Cole SR, Warady B, Munoz A,. Glomerular filtration rate via plasma iohexol disappearance: pilot study for chronic kidney disease in children. Kidney Int. 2006; 69 (11): 2070-2077.
43. Vieux R, Hascoet JM, Merdariu D, Fresson J, Guillemin F,. Glomerular filtration rate reference values in very preterm infants. Pediatrics. 2010; 125 (5): e1186-e1192.
44. Chen N, Aleksa K, Woodland C, Rieder M, Koren G,. Ontogeny of drug elimination by the human kidney. Pediatr Nephrol. 2006; 21 (2): 160-168.
45. Guignard JP, Drukker A,. Why do newborn infants have a high plasma creatinine? Pediatrics. 1999; 103 (4): e49.
46. George I, Mekahli D, Rayyan M, Levtchenko E, Allegaert K,. Postnatal trends in creatinemia and its covariates in extremely low birth weight (ELBW) neonates. Pediatr Nephrol. 2011; 26 (10): 1843-1849.
47. Koralkar R, Ambalavanan N, Levitan EB, McGwin G, Goldstein S, Askenazi D,. Acute kidney injury reduces survival in very low birth weight infants. Pediatr Res. 2011; 69 (4): 354-358.
48. Coresh J, Astor BC, McQuillan G, et al., Calibration and random variation of the serum creatinine assay as critical elements of using equations to estimate glomerular filtration rate. Am J Kidney Dis. 2002; 39 (5): 920-929.
49. Filler G, Lopes L, Harrold J, Bariciak E,. Beta-trace protein may be a more suitable marker of neonatal renal function. Clin Nephrol. 2014; 81 (4): 269-276.
50. White CA, Akbari A, Doucette S, et al., Estimating GFR using serum beta trace protein: accuracy and validation in kidney transplant and pediatric populations. Kidney Int. 2009; 76 (7): 784-791.
51. Shlipak MG, Matsushita K, Arnlov J, et al., Cystatin C versus creatinine in determining risk based on kidney function. N Engl J Med. 2013; 369 (10): 932-943.
52. Coulthard MG., Comparison of methods of measuring renal function in preterm babies using inulin. J Pediatr. 1983; 102 (6): 923-930.
53. Neuman G, Nulman I, Adeli K, Koren G, Colantonio DA, Hellden A,. Implications of serum creatinine measurements on GFR estimation and vancomycin dosing in children. J Clin Pharmacol. 2014; 54 (7): 785-791.
54. Allegaert K, Kuppens M, Mekahli D, et al., Creatinine reference values in ELBW infants: impact of quantification by Jaffe or enzymatic method. J Matern Fetal Neonat. 2012; 25 (9): 1678-1681.
55. Srivastava T, Alon US, Althahabi R, Garg U,. Impact of standardization of creatinine methodology on the assessment of glomerular filtration rate in children. Pediatr Res. 2009; 65 (1): 113-116.
56. Schwartz GJ, Brion LP, Spitzer A,. The use of plasma creatinine concentration for estimating glomerular filtration rate in infants, children, and adolescents. Pediatr Clin North Am. 1987; 34 (3): 571-590.
57. Schwartz GJ, Feld LG, Langford DJ,. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatr. 1984; 104 (6): 849-854.
58. Leger F, Bouissou F, Coulais Y, Tafani M, Chatelut E,. Estimation of glomerular filtration rate in children. Pediatr Nephrol. 2002; 17 (11): 903-907.
59. Pottel H, Mottaghy FM, Zaman Z, Martens F,. On the relationship between glomerular filtration rate and serum creatinine in children. Pediatr Nephrol. 2010; 25 (5): 927-934.
60. Mattman A, Eintracht S, Mock T, et al., Estimating pediatric glomerular filtration rates in the era of chronic kidney disease staging. J Am Soc Nephrol. 2006; 17 (2): 487-496.
61. Myers GL, Miller WG, Coresh J, et al., Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem. 2006; 52 (1): 5-18.
62. Panteghini M., Enzymatic assays for creatinine: time for action. Clin Chem Lab Med. 2008; 46 (4): 567-572.
63. Bjork J, Back SE, Sterner G, et al., Prediction of relative glomerular filtration rate in adults: new improved equations based on Swedish Caucasians and standardized plasma-creatinine assays. Scand J Clin Lab Invest. 2007; 67 (7): 678-695.
64. Cockcroft DW, Gault MH,. Prediction of creatinine clearance from serum creatinine. Nephron. 1976; 16 (1): 31-41.
65. Asberg A, Bjerre A, Neely M,. New algorithm for valganciclovir dosing in pediatric solid organ transplant recipients. Pediatr Transplant. 2014; 18 (1): 103-111.
66. Sherwin CM, Svahn S, Van der Linden A, Broadbent RS, Medlicott NJ, Reith DM,. Individualised dosing of amikacin in neonates: a pharmacokinetic/pharmacodynamic analysis. Eur J Clin Pharmacol. 2009; 65 (7): 705-713.
67. 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 (7): 718-726.
68. Zhao W, Biran V, Jacqz-Aigrain E,. Amikacin maturation model as a marker of renal maturation to predict glomerular filtration rate and vancomycin clearance in neonates. Clin Pharmacokinet. 2013; 52 (12): 1127-1134.
69. Marsot A, Boulamery A, Bruguerolle B, Simon N,. Vancomycin: a review of population pharmacokinetic analyses. Clin Pharmacokinet. 2012; 51 (1): 1-13.
70. de Hoog M, Mouton JW, van den Anker JN,. Vancomycin: pharmacokinetics and administration regimens in neonates. Clin Pharmacokinet. 2004; 43 (7): 417-440.
71. Pacifici GM, Allegaert K,. Clinical pharmacokinetics of vancomycin in the neonate: a review. Clinics (Sao Paulo). 2012; 67 (7): 831-837.
72. Golper TA, Noonan HM, Elzinga L, et al., Vancomycin pharmacokinetics, renal handling, and nonrenal clearances in normal human subjects. Clin Pharmacol Ther. 1988; 43 (5): 565-570.
73. Gonzalez-Martin G, Acuna V, Perez C, Labarca J, Guevara A, Tagle R,. Pharmacokinetics of vancomycin in patients with severely impaired renal function. Int J Clin Pharmacol Ther. 1996; 34 (2): 71-75.
74. Cutler NR, Narang PK, Lesko LJ, Ninos M, Power M,. Vancomycin disposition: the importance of age. Clin Pharmacol Ther. 1984; 36 (6): 803-810.
75. Macias WL, Mueller BA, Scarim SK,. Vancomycin pharmacokinetics in acute renal failure: preservation of nonrenal clearance. Clin Pharmacol Ther. 1991; 50 (6): 688-694.
76. McNamara PJ, Alcorn J,. Protein binding predictions in infants. AAPS PharmSci. 2002; 4 (1): E4.
77. Sokol PP., Mechanism of vancomycin transport in the kidney: studies in rabbit renal brush border and basolateral membrane vesicles. J Pharmacol Exp Ther. 1991; 259 (3): 1283-1287.
78. Jariyawat S, Sekine T, Takeda M, et al., The interaction and transport of beta-lactam antibiotics with the cloned rat renal organic anion transporter 1. J Pharmacol Exp Ther. 1999; 290 (2): 672-677.
79. Rybak M, Lomaestro B, Rotschafer JC, et al., Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health-System Pharm. 2009; 66 (1): 82-98.
80. Moise-Broder PA, Forrest A, Birmingham MC, Schentag JJ,. Pharmacodynamics of vancomycin and other antimicrobials in patients with Staphylococcus aureus lower respiratory tract infections. Clin Pharmacokinet. 2004; 43 (13): 925-942.
81. Rybak MJ., The pharmacokinetic and pharmacodynamic properties of vancomycin. Clin Infect Dis. 2006; 42 Suppl 1: S35-S39.
82. Craig WA,. Basic pharmacodynamics of antibacterials with clinical applications to the use of beta-lactams, glycopeptides, and linezolid. Infect Dis Clin North Am. 2003; 17 (3): 479-501.
83. Lutsar I, Metsvaht T,. Understanding pharmacokinetics/pharmacodynamics in managing neonatal sepsis. Curr Opin Infect Dis. 2010; 23 (3): 201-207.
84. Le J, Bradley JS, Murray W, et al., Improved vancomycin dosing in children using area under the curve exposure. Pediatr Infect Dis J. 2013; 32 (4): e155-e163.
85. Le J, Vaida F, Nguyen E, et al., Population-based pharmacokinetic modeling of vancomycin in children with renal insufficiency. J Pharmacol Clin Toxicol. 2014; 2 (1): 1017-1026.
86. Frymoyer A, Hersh AL, El-Komy MH, et al., Association between vancomycin trough concentration and AUC in neonates. Antimicrob Agents Chemother. 2014; 58 (11): 6454-6461.
87. Lamarre P, Lebel D, Ducharme MP,. A population pharmacokinetic model for vancomycin in pediatric patients and its predictive value in a naive population. Antimicrob Agents Chemother. 2000; 44 (2): 278-282.
88. Lo YL, van Hasselt JG, Heng SC, Lim CT, Lee TC, Charles BG,. Population pharmacokinetics of vancomycin in premature Malaysian neonates: identification of predictors for dosing determination. Antimicrob Agents Chemother. 2010; 54 (6): 2626-2632.
89. Marques-Minana MR, Saadeddin A, Peris JE,. Population pharmacokinetic analysis of vancomycin in neonates. A new proposal of initial dosage guideline. Br J Clin Pharmacol. 2010; 70 (5): 713-720.
90. de Hoog M, Schoemaker RC, Mouton JW, van den Anker JN,. Vancomycin population pharmacokinetics in neonates. Clin Pharmacol Ther. 2000; 67 (4): 360-367.
91. Seay RE, Brundage RC, Jensen PD, Schilling CG, Edgren BE,. Population pharmacokinetics of vancomycin in neonates. Clin Pharmacol Ther. 1994; 56 (2): 169-175.
92. Silva R, Reis E, Bispo MA, et al., The kinetic profile of vancomycin in neonates. J Pharm Pharmacol. 1998; 50 (11): 1255-1260.
93. Schwartz GJ, Haycock GB, Edelmann CM Jr, Spitzer A,. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics. 1976; 58 (2): 259-263.
94. Bhongsatiern J, Stockmann C, Roberts JK, et al., Evaluation of vancomycin use in late-onset neonatal sepsis using the AUC24/MIC >= 400 target. Ther Drug Monit. 2015; 37 (6): 756-765.
95. Beal SL, Sheiner LB,. NONMEM User's Guides. San Francisco: University of California; 1989.
96. Stockmann C, Hersh AL, Roberts JK, et al., Predictive performance of a vancomycin population pharmacokinetic model in neonates. Infect Dis Ther. 2015; 4 (2): 187-198.
97. Sheiner LB, Beal SL,. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 1981; 9 (4): 503-512.
98. Boer DP, de Rijke YB, Hop WC, Cransberg K, Dorresteijn EM,. Reference values for serum creatinine in children younger than 1 year of age. Pediatr Nephrol. 2010; 25 (10): 2107-2113.
99. Du Bois D, Du Bois EF,. A formula to estimate the approximate surface area if height and weight be known. 1916. Nutrition. 1989; 5 (5): 303-311; discussion 312-303.