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• W1990677975 abstract "Fluoroquinolone antibiotics were hailed as highly effective and safe, with excellent oral bioavailability when originally introduced, but widespread resistance is limiting their utility.1Pakyz A.L. Lee J.A. Ababneh M.A. Harpe S.E. Oinonen M.J. Polk R.E. Fluoroquinolone use and fluoroquinolone-resistant Pseudomonas aeruginosa is declining in US academic medical centre hospitals.J Antimicrob Chemother. 2012; 67: 1562-1564Crossref PubMed Scopus (12) Google Scholar The Infectious Diseases Society of America and the American Thoracic Society recommend fluoroquinolones for inpatient management of community-acquired pneumonia.2Mandell L.A. Wunderink R.G. Anzueto A. et al.Infectious Diseases Society of America/American Thoracic Society Consensus Guidelines on the management of community-acquired pneumonia in adults.Clin Infect Dis. 2007; 44: S27-S72Crossref PubMed Scopus (4603) Google Scholar Ciprofloxacin dosage adjustments are recommended for patients with decreased kidney function and for those receiving CRRT. After a prospective randomized clinical trial comparing 20 and 35 mL/kg/h CRRT failed to show a survival benefit of intensive RRT, we hypothesized that dialytic clearance of antibiotics in the higher dose arm might have led to systemic underdosing and inadequate treatment of infection.3VA/NIH Acute Renal Failure Trial NetworkIntensity of renal support in critically ill patients with acute kidney injury.N Engl J Med. 2008; 359: 7-20Crossref PubMed Scopus (1302) Google Scholar Three observational studies of ciprofloxacin pharmacokinetics in CRRT enrolled 6, 3, and 7 participants, respectively, with widely varying CRRT and ciprofloxacin prescriptions; only ciprofloxacin administered without dosage adjustment for kidney failure or RRT resulted in adequate peak concentrations.4Wallis S.C. Mullaney D.V. Lipman J. Rickard C.M. Daley P.J. Pharmocokinetics of ciprofloxacin in ICU patients on continuous veno-venous haemodiafiltration.Intensive Care Med. 2001; 27: 665-672Crossref PubMed Scopus (45) Google Scholar, 5Hayakawa M. Fujita I. Iseki K. Gando S. The administration of ciprofloxacin during continuous renal replacement therapy: pilot study.ASAIO J. 2009; 55: 243-245Crossref PubMed Scopus (9) Google Scholar, 6Spooner A.M. Deegan C. DArcy D.M. Gowing C.M. Donnelly M.B. Corrigan O.I. An evaluation of ciprofloxacin pharmacokinetics in critically ill patients undergoing continuous veno-venous haemodiafiltration.BMC Clin Pharmacol. 2011; 11: 11Crossref PubMed Scopus (21) Google Scholar Therefore, we conducted an institutional review board–approved prospective observational study of antibiotic pharmacokinetics and pharmacodynamics in critically ill patients receiving continuous venovenous hemodialysis (CVVHD) and concomitant antibiotic therapy. We report pharmacokinetic measurements from 14 patients at The Cleveland Clinic receiving CVVHD and ciprofloxacin between February 1, 2009, and July 1, 2012. Participants or their surrogates provided informed consent prior to study procedures. Demographic and clinical data were recorded on case report forms. Paired blood and CRRT effluent samples were drawn prior to an antibiotic dose, 30 minutes after the 30-minute infusion, and immediately before the following dose. Free ciprofloxacin was analyzed by reverse-phase high-performance liquid chromatography, and a single-compartment pharmacokinetic model was fit to the data using nonlinear mixed-effects techniques. Patients received CVVHD using the Prismaflex system (Gambro Renal Products) with M-100 dialyzer sets or the NxStage System One (NxStage Medical) dialysis system with the Express cartridge according to instrument availability and nephrology consulting service discretion. Patients were treated exclusively using the CVVHD mode with a dialysis dose targeted to 25 mL/kg/h. Anticoagulation was achieved with an infusion of unfractionated heparin (250-500 IU/h) as tolerated. Peak antibiotic levels were measured and compared with published susceptibility breakpoints. For Enterobacteriaciae and Pseudomonas aeruginosa, the MIC is 1 μg/mL for ciprofloxacin.7Clinical Laboratory Standards I. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-First Informational Supplement. Clinical and Laboratory Standards Institute, Wayne, PA2011Google Scholar Peak ciprofloxacin concentrations ≥ 10 μg/mL were considered to have attained pharmacodynamic targets.7Clinical Laboratory Standards I. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-First Informational Supplement. Clinical and Laboratory Standards Institute, Wayne, PA2011Google Scholar, 8van Zanten A.R. Polderman K.H. van Geijlswijk I.M. et al.Ciprofloxacin pharmacokinetics in critically ill patients: a prospective cohort study.J Crit Care. 2008; 23: 422-430Abstract Full Text Full Text PDF PubMed Scopus (79) Google Scholar Others suggest that AUC/MIC > 100 is predictive of outcome.9Burgess D.S. Use of pharmacokinetics and pharmacodynamics to optimize antimicrobial treatment of Pseudomonas aeruginosa infections.Clin Infect Dis. 2005; 40: S99-S104Crossref PubMed Scopus (62) Google Scholar Detailed analytic and statistical methods are presented in Item S1. Fourteen patients were enrolled and had adequate data for analysis (Table 1). Participants were evenly distributed with respect to sex. Mortality was extremely high (10/14), much higher than the 50% mortality rate we observed for patients receiving piperacillin-tazobactam and CRRT or observed in recent large studies of dialysis dose in AKI.3VA/NIH Acute Renal Failure Trial NetworkIntensity of renal support in critically ill patients with acute kidney injury.N Engl J Med. 2008; 359: 7-20Crossref PubMed Scopus (1302) Google Scholar, 10Bauer S.R. Salem C.A. Connor J. et al.Pharmacokinetics and pharmacodynamics of piperacillin-tazobactam in 42 patients treated with concomitant CRRT.Clin J Am Soc Nephrol. 2012; 7: 452-457Crossref PubMed Scopus (61) Google Scholar Only 1 of 14 patients attained the target peak ciprofloxacin concentration ≥ 10 μg/mL (Fig 1). Most (57%) patients attained AUC0-24/MIC > 100. Simple linear regression analysis of peak serum concentration versus patient weight and CRRT clearance demonstrated significant dependence of peak concentration on CRRT clearance (P = 0.03). CRRT ciprofloxacin clearance was associated with apparent volume of distribution (P = 0.003), but patient weight was not. In addition, there was no statistically significant association between CRRT ciprofloxacin clearance and total drug clearance. Trough values are highly informative about the elimination rate. Hence, the latter finding may be partly due to weak statistical power because only 5 of the second trough values were measured.Table 1Descriptive Statistics and Estimates of Single-Compartment Pharmacokinetic Model Parameters for the 14 Patients Receiving Ciprofloxacin and CRRTVariableValueAge (y)66 [64-71]; 68 ± 6M:F7:7Weight (kg)93 [88-105]; 94 ± 15Dialysate flow rate (mL/h)2,150 [2,000-2,475]; 2,271 ± 627Dialysate flow rate (mL/kg/h)23.3 [20.8-24.9]CRRT ciprofloxacin clearance (mL/min)36.4 [26.3-45.8]; 38.1 ± 12.7Peak ciprofloxacin concentration (μg/mL)5.0 [4.1-7.3]; 5.7 ± 2.5No. surviving hospitalization4Model parameter estimates V (L)108.4 [98.2-153.9]; 116 ± 43 CL (mL/min)129.8 [99.0-172.0]; 148 ± 72 Ciprofloxacin AUC0-24/MIC126.2 [60.8-162.1]; 120.6 ± 62.6Note: Unless otherwise indicated, values are given as median [IQR]; mean ± SD. Volumes of distribution appear lower than the previously reported 2.5 L/kg, although only free drug is reported. Peak concentrations were below the target of 10 μg/mL; AUC0-24/MIC estimates appear reassuring because most patients attained AUC0-24/MIC > 100. However, single-compartment models likely overestimate AUC. Clearance estimates exceed measured CRRT clearance in part because the single-compartment parameter estimate incorporates both intercompartmental and elimination clearances.Abbreviations: AUC, area under the curve; CL, clearance; CRRT, continuous renal replacement therapy; MIC, minimum inhibitory concentration; V, volume. Open table in a new tab Note: Unless otherwise indicated, values are given as median [IQR]; mean ± SD. Volumes of distribution appear lower than the previously reported 2.5 L/kg, although only free drug is reported. Peak concentrations were below the target of 10 μg/mL; AUC0-24/MIC estimates appear reassuring because most patients attained AUC0-24/MIC > 100. However, single-compartment models likely overestimate AUC. Clearance estimates exceed measured CRRT clearance in part because the single-compartment parameter estimate incorporates both intercompartmental and elimination clearances. Abbreviations: AUC, area under the curve; CL, clearance; CRRT, continuous renal replacement therapy; MIC, minimum inhibitory concentration; V, volume. Our observations are broadly consistent with those of other groups despite differences in patient population and RRT mode. In the context of emerging widespread fluoroquinolone resistance, the nearly universal prevalence of subtherapeutic ciprofloxacin concentrations in patients receiving doses adjusted according to current published guidelines is especially worrisome. The apparently excellent target attainment suggested by the AUC/MIC estimates in our model should not support complacency regarding present dosing schemes because our single-compartment model is highly likely to overestimate this parameter, possibly by a wide margin. The apparent association between CRRT clearance and volume of distribution may be due to “first-pass” effects wherein drug is infused into blood and removed by the CRRT circuit before it can be distributed throughout tissues. The somewhat surprising lack of correlation between CRRT clearance and total clearance may be due to low statistical power or because a single-compartment model inadequately captures distinct distribution and elimination phases. Further work is needed to refine dosing tables or develop pragmatic approaches to therapeutic drug monitoring. We acknowledge Michelle Garcia, Rita Brienza, Lydia Sweeney, and Tracy Seifert for assistance in study execution. Support: Funding was provided by The Cleveland Clinic and the National Institutes of Health 1R21 DK088045 (WHF). Financial Disclosure: The authors declare that they have no relevant financial interests. Contributions: Research idea and study design: WHF, MJC, SRB; data acquisition: MJC, CS, MA, OAA, PNM, JJG; data analysis/interpretation: PNM, JJG, WHF, MSS; statistical analysis: MSS. Each author contributed important intellectual content during manuscript drafting or revision and accepts accountability for the overall work by ensuring that questions pertaining to the accuracy or integrity of any portion of the work are appropriately investigated and resolved. WHF takes responsibility that this study has been reported honestly, accurately, and transparently; that no important aspects of the study have been omitted, and that any discrepancies from the study as planned have been explained. Download .pdf (.06 MB) Help with pdf files Supplementary Item S1 (PDF)Detailed methods and participants’ measured plasma and effluent ciprofoxacin concentrations." @default.
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• W1990677975 title "Ciprofloxacin Pharmacokinetics in Critically Ill Patients Receiving Concomitant Continuous Venovenous Hemodialysis" @default.
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