ICU PHARMACOTHERAPY IN SPECIAL POPULATIONS: Part 2- Renal replacement and extracorporeal therapies

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1 ICU PHARMACOTHERAPY IN SPECIAL POPULATIONS: Part 2 Renal replacement and extracorporeal therapies Disclosures Hospira, Inc. Consultant Cubist Pharmaceuticals Consultant Jeffrey F. Barletta, Pharm.D., FCCM Associate Professor & Vice Chair Department of Pharmacy Practice Midwestern University, College of Pharmacy Glendale, Arizona Objectives Part 1: Craft a dosing regimen for medication therapy in ICU patients using principles of dose individualization Develop a plan for crafting a medication regimen for a morbidly obese ICU patient. Part 2: Describe the factors that influence drug dosing in patients on: Renal replacement therapies (RRT) Extracorporeal membranous oxygenation (ECMO) Molecular adsorbent recirculation systems (MARS) Acute Kidney Injury & Renal Replacement Therapies 1

2 Epidemiology of AKI Definition of Acute Kidney Injury RIFLE Increase in SCr to 1.5 times baseline Urine volume < 0.5 ml/kg/hr for 6 hours Acute Kidney Injury Network (AKIN) Increase in SCr by 0.3 mg/dl within 48 hours Increase in SCr to 1.5 times baseline Urine volume < 0.5 ml/kg/hr for 6 hours Hoste, et al. Crit Care Med 2008;36:S KDIGO Increase in SCr by 0.3 mg/dl within 48 hours Increase in SCr to 1.5 times baseline which is known or presumed to have occurred within the prior 7 days Urine volume < 0.5 ml/kg/hr for 6 hours Bellomo, et al. Critical Care 2004;8:R Mehta, et al. Critical Care 2007;11:R31. KDIGO, Kidney Internatational Suppl 2012;2:1936. KDIGO Staging for AKI Pharmacokinetic & Pharmacodynamic Principles Stage SCr Criteria Urine Output Criteria Cmax 1 Increase 0.3 mg/dl or 1.5 to 1.9 times baseline < 0.5 ml/kg/hr for 6 12 hours Cmax:MIC to 2.9 times baseline 3 times baseline or SCr 4 mg/dl or RRT < 0.5 ml/kg/hr for 12 hours < 0.3 ml/kg/hr for 24 hours or anuria for 12 hours Concentration T>MIC AUIC PAE MIC KDIGO, Kidney Internatational Suppl 2012;2:1936. Cmin Time 2

3 Pharmacodynamics Antimicrobial PD Measure Threshold for Efficacy Time Dependent Penicillins ft > MIC >50% Cephalosporins ft > MIC >50% to 70% Carbapenems ft > MIC >40% Vancomycin AUC:MIC >400:1 Linezolid AUC:MIC >80 to 120 Concentration Dependent Aminoglycosides fcmax:mic >8:1 to 10:1 Fluoroquinolones AUC:MIC >125:1 (Gm neg.) Barletta, et al. Current Concepts in Adult Critical Care. Greenberg S, Bittner EA (Eds) Edition Pharmacokinetic Changes with AKI Absorption Decreased perfusion to the gut Enteral feeding status Distribution Increased Vd Temporal changes Metabolism Preservation of nonrenal clearance for some drugs Elimination Glomerular filtration Tubular secretion & reabsorption NonRenal Clearance: AKI vs. ESKD Intermittent Hemodialysis vs. CRRT: Dialysis dependence among survivors Drug Normal Cl AKI ESKD Imipenem 130 ml/min ml/min 50 ml/min Meropenem ml/min ml/min ml/min Vancomycin 40 ml/min 15 ml/min 5 ml/min Cl TOTAL = Cl CRRT + Cl NONRENAL + Cl RESIDUAL Schneider, et al. Intensive Care Med 2013;39:

4 Pharmacokinetics of RRT: Intermittent Hemodialysis vs. CRRT CRRT: Mechanism of Drug Removal Intermittent Hemodialysis CRRT CRRT Concentration ke 1 HD ke 2 Concentration ke 1 Convection Time Time Diffusion Tolwani. N Engl J Med 2012;367: Factors that influence clearance Pharmacokinetic Properties Protein binding Volume of distribution Molecular weight Mode of CRRT Protein Binding Free Drug Blood Bound Drug Ultrafiltrate Protein CRRT dose Pre versus postfilter replacement solutions (CVVH) Filter type 4

5 Influence of Volume of Distribution Antibiotic Molecular Weights CVVHD CVVH Replacement Solution Qb Spent Dialysate and/or Ultrafiltrate Dialysate Qd RRT Qb Patient Central Compartment Pool 1 6L? k 12 k 21 Pool 3??? k 32 k 23 Pool 2??? k 10 Systemic Elimination Mueller, et al. Artificial Organs 2003;27: Pea, et al. Clin Pharmacokinet 2007;46: Influence of CRRT Mode, Dose & Molecular Weight on Drug Clearance Hemofiltration Rate & Vancomycin Trough CVVHD: Ceftazidime Vancomycin Clearance Clearance Dialysate flow rate Dialysate flow rate Matzke, et al. Antimicrob Agents Chemother 2000;44: Joy, et al. Am J Kidney Dis 1998;31: Frazee, et al. Antimicrob Agent Chemother 2012;56:

6 Vancomycin Concentrations and Outcome Day 1 Day 2 PD parameter Cmin : MIC AUC : MIC Cmin : MIC AUC : MIC *MIC determined by broth microdilution Clinical Failure Threshold RR (95% CI) 1.24 ( ) 0.54 ( ) 1.47 ( ) 0.58 ( ) Lodise, et al. Clin Infect Dis 2014;59: Strategies for Drug Dosing in CRRT Use published clinical studies in patients with AKI that utilized a similar technique for CRRT. Meropenem PK Properties: MW = 437 D SC = 1.0 Vd = L/kg Tegeder I, et al. CPT CVVH: UFR ~1100 ml/hr AN69 hemofilter 500 mg Q 12 hrs Thalhammer F, et al. AAC CVVH: UFR 3000 ml/hr polysulfone (Amicon) 1000 mg Q 8 hrs Meyer M, et al. AJKD CVVHDF: 750 ml/hr HD, 1250 ml/hr UF AN69 hemofilter 1000 mg Q 12 hrs 18 ml/min 50 ml/min 33 ml/min Strategies for Drug Dosing in CRRT Tertiary references or review articles Strategies for Drug Dosing in CRRT Creatinine Clearance Method Cl TOTAL = (Sc x Qf) + Cl RESIDUAL Cl CRRT Use Cl TOTAL as estimation for CrCl and use published dosing recommendations. Effluent Rates: 2 L/hr 1 L/hr 1 2 L/hr Not specified Eyler, et al. Nat Rev Nephrol 2011;7:

7 Strategies for Drug Dosing in CRRT Adjusted Clearance Method Cl ADJUSTED = Cl CRRT + Cl NONRENAL + Cl RESIDUAL Sc x Qf Adjustment Factor = Cl ADJUSTED / Cl NORMAL Use PD principles to determine if: dose should be lowered (timedependent) or frequency prolonged (concentration dependent) Are Recommended Doses High Enough? Percentage of Patients Meeting PD Goals Dosing Regimen: < 48 hrs 48 hrs Meropenem 1 gm Q 12 1 gm Q 8 Pip/Tazo 4 gm Q 6 4 gm Q 6 Cefepime 2 gm Q 12 2 gm Q 8 71% 96% 66% 57% 0% 100% 87% 100% 78% 92% 0% 83% Excessive 53% 69% 67% Seyler, et al. Critical Care 2011;15:R137. Beumier, et al. Critical Care 2014;18:R105. Take home points A onesizefitsall approach should be abandoned. PK alterations encountered with AKI is not the same as ESKD. CRRT dose intensity must be considered. Use caution when interpreting published dosing recommendations EXTRACORPOREAL MEMBRANE OXYGENATION Do not underdose safe medications. 7

8 What is ECMO? ECMO: A Historical Perspective Variation of CPB Can be used for days weeks Basic types of ECMO: VV ECMO VA ECMO Blum, et al. Chest 2015 Mar 19 [Epub ahead of print] Components of ECMO EMCO Circuits Heat exchanger Pump technology Roller pump Centrifugal pump Membrane oxygenators Silicon fibers Polypropylene Hollow polymethylpentene fibers Tubing Polyvinyl chloride Coated vs. uncoated Length of tubing (neonatal vs. adult) DelSorbo, et al. Lancet Respir Med 2014;2: Francesco Formica and Giovanni Paolini (2013). VenoArterial Extracorporeal Membrane Oxygenation for Refractory Cardiogenic Shock and Cardiac Arrest, Principles and Practice of Cardiothoracic Surgery, Dr. Michael Firstenberg (Ed.), ISBN: , InTech, DOI: / Available from: 8

9 ECMO: Pharmacokinetic Principles ECMO Circuit & Drug Sequestration Limitations of PK studies Different ECMO equipment Neonates Heterogeneity of patient population No control groups Pertinent factors Type of oxygenator, tubing, etc. Age of circuit Blood flow rate Drug specific Drug lipophilicity Protein binding Shekar, et al. J Crit Care 2012;27;741:e9e18. Drug Lipophilicity Drug Log P Fentanyl 4.05 Hydromorphone 0.9 Morphine 0.89 Propofol 3.79 Midazolam 3.33 Dexmedetomidine 2.8 Lorazepam 2.39 Vancomycin 3.1 Linezolid 0.9 Cefepime 0.37 Piperacillin 0.3 Ciprofloxacin 0.28 Meropenem 0.6 Fluconazole 0.4 Caspofungin ECMO & Sedation Propofol Midazolam Lemaitre, et al. Crit Care 2015;19:40. 9

10 ECMO & Analgesia Analgesic & Sedative Doses in ECMO Fentanyl Morphine Days Midazolam Mean total daily dose Morphine Mean total daily dose Days Daily dose increase = 29 mg/day Daily dose increase = 18 mg/day Median dose was 175 mg/day (24 1,092) Shekar, et al. Crit Care 2012;16:R194. Shekar, et al. Anaesth Intensive Care 2012;40: Variability Across Studies Percent of Drug Remaining in Circuit Antimicrobials: Percent of drug recovery Study Harthan, et al. Time (hr) 24 Oxygenator PMP Midazolam 19 Morphine 102 Fentanyl 33 Drug Ciprofloxacin Control 119 ECMO 96 log P 0.28 Protein bound 2040 Shekar, et al. 24 PMP Meropenem Dagan, et al. Mulla, et al. Wildschut, et al Silicone Silicone Silicone Ceftriaxone Vancomycin Polypropylene Linezolid BhattMeht, et al. Mehta, et al Silicone Silicone 80 0 Fluconazole Caspofungin Harthan, et al. J Pediatr Pharmacol Ther 2014;19: Shekar, et al. Critical Care 2015;19:

11 ECMO Sequestration: Meropenem & Piperacillin/Tazobactam Take home points Significant variability exists with PK data according to ECMO setup. Excessive Adequate Insufficient Drugrelated factors that appear to influence sequestration are lipophilicity and protein binding. Analgesic and sedation regimens will need to be adjusted when ECMO begins and ceases. Use published PK data to adjust antimicrobial regimens. ECMO Control Meropenem ECMO Control Pip/Tazo Therapeutic drug monitoring is crucial. Donadello, et al. Internat J Antimicrob Ag 2015;45: What is MARS? Pathophysiologic Hypothesis: The accumulation of albumin bound substances attributable to insufficient clearance by the liver results in elevated tissue levels of toxic substances. MOLECULAR ADSORBENT RECIRCULATION SYSTEMS MARS: Liver support system Removes protein bound and water soluble toxins Albumin dialysis 11

12 MARS: Mechanism of Effect MARS Toxin Blood Circuit Albumin Circuit Dialysis Circuit Blood Albumin Dialysis filter Dialysate Albumin MARS Flux Ion Charcoal Exchanger Membrane Blood Dialysate MARS System CRRT Wong. Nat Clin Pract Gastroenterol Hepatol 2007;4:4351. Antibiotic Elimination & MARS Piperacillin / tazobactam: Infusion time 4x MIC 3x MIC Concentration 2x MIC Meropenem & Moxifloxacin: Ruggero, et al. Transpl Infect Dis 2013;15: Meropenem Moxifloxacin MARSflux dialyzer Charcoal Ion Exchanger Lowflux dialyzer Roth, et al. Acta Anaesthesiol Scand 2013;57:

13 Take home points With MARS therapy, drugs with both high and low degrees of protein binding will be removed. The total clearance may be more than that observed with CRRT alone. Therapeutic drug monitoring is essential. Future research is needed. 13

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