7/17/2017 FSHP 2017 ANNUAL MEETING. Medication Considerations for the Adult/Pediatric ICU Patient Receiving Renal Replacement Therapy

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1 FSHP Medication Considerations for the Adult/Pediatric ICU Patient Receiving Renal Replacement Therapy Disclosure I do not have (nor does any immediate family member have) a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation. Calvin Tucker, PharmD, BCPS, BCCCP Julianna Crain, PharmD, BCPPS, AE-C Objectives 1. Explain the various renal replacement therapy (RRT) modality preferences to treat critically ill adults and children 2. Discuss the importance of anticoagulation during RRT 3. Review the dialyzable properties of medications and technical aspects of dialysis procedures that influence drug removal during RRT 4. Explain medication dosing considerations with various RRT modalities 5. Describe necessary timing alterations for monitoring drug levels with RRT 6. Describe necessary medication dosing strategies and recommendations for RRT Acute Kidney Injury-Prevalence Affects approximately 5-7% of hospitalized patients Approximately 60% of ICU patients experience AKI 23.5% of patients with AKI require RRT The true incidence of acute kidney injury depends on the population studied Mortality among ICU patients with AKI and multi-organ failure has been reported to be more than 50% If RRT is required, mortality may be as high as 80% Kellum et al Crit Care Med 2008 Vol. 36, No. 4 (Suppl.) Barrantes et al Crit Care Med 2008 Vol. 36, No. 5 Acute Kidney Injury-Definition Characterized by a sudden decrease in function over a period of to days Magnitude and severity classified by variations in serum creatinine and urine output Kidney Disease: Improving Global Outcomes (KDIGO) Risk, Injury, Failure, Loss of kidney function and Endstage kidney disease (RIFLE) Classification The Acute Kidney Injury Network (AKIN) Multiple definitions led to disparity in the reported incidence making it difficult compare literature focusing on AKI Acute Kidney Injury-Definition No consistent or standard definition in pediatrics for acute renal failure(arf) or acute kidney injury (AKI) prifle vs. AKIN vs. KDIGO Defining AKI in pediatrics is important! AKI incidences according to prifle, AKIN, and KDIGO: 51.1%, 37.3%, and 40.3%, respectively Higher morbidity and mortality in the pediatric intensive care unit (PICU), regardless of stage: prifle, 13.4% vs1.8%; AKIN, 16.0% vs 2.3%; KDIGO, 15.3% vs 2.3%; all P<0.001 Increased length of stay (LOS) in PICU Kellum et al Crit Care Med 2008 Vol. 36, No. 4 (Suppl.) Gibney et al J Thorac Dis 2016;8(9): Sutherland S, et al. Clin J Am Soc Nephrol 10:

2 Acute Kidney Injury-Causes The causes of acute kidney injury can be divided into three categories: Pre-renal Intrinsic renal Post-renal Abnormalities in fluid and electrolyte balance are some of the most common problems Reductions in GFR could lead to azotemia that may be indicative of disease or normal pathology Irreversible damage progresses towards chronic kidney disease Sutherland S, et al. Clin J Am Soc Nephrol 10: 2015 Kellum et al Crit Care Med 2008 Vol. 36, No. 4 (Suppl.) Barrantes et al Crit Care Med 2008 Vol. 36, No. 5 Acute Kidney Injury Pre-renal Systemic vasoconstriction or vasodilation Volume depletion Intrinsic renal Interstitial Tubular Vascular Post-renal Intra-renal and extra-renal obstruction Indications for Renal Replacement Manifestation Oliguria Anuria Elevated plasma urea Elevated serum creatinine Hyperkalemia Pulmonary edema Metabolic acidosis Interpretive Range Urine output <500 ml/day No urine output BUN > 100 mg/dl Scr > 5.6 mg/dl K > 6.5 meq/l Unresponsive to diuretics ph < 7.2 Kellum et al Crit Care Med 2008 Vol. 36, No. 4 (Suppl.) Barrantes et al Crit Care Med 2008 Vol. 36, No. 5 Joy et al Ann Pharmacother 1998;32: Tolwani et al N Engl J Med 2012;367: Indications for RRT - Pediatrics Fluid overload (> 10%) % FO = ([total fluid intake total fluid output (L)]/ admission body weight (kg)*100 Uremia Hyperkalemia ( K > 5.5 mmol/l) Metabolic acidosis ( ph < 7.1) Intoxication Tumor lysis syndrome Inborn errors of metabolism RRT Modalities Preferred appropriate choice: Patient s clinical status and characteristics Dialytic indication Institution s available resources Provider s beliefs Intermittent hemodialysis (IHD) Peritoneal Dialysis (PD) Continuous renal replacement therapies (CRRT) Veno-venous access and external blood pump SCUF CVVH CVVHD CVVHDF Boschee E, et al. Journal of Critical Care 29 (2014) Fleming G, et al. Pediatr Crit Care Med 2012 Vol. 13, No. 5 Walters S, et al. Pediatr Nephrol (2009) 24:

3 Components of CRRT Priming the Circuit - Pediatrics Blood Small patient (< 4kg) If the circuit >10% of their blood volume Albumin If hemodynamically unstable Risk of hypocalcemia? Saline Common Waters,P. CRRT Review and Refresh. Retrieved from Kellum J, Bellomo R, Ronco C. Continuous Renal Replacement Therapy. New York: Oxford University Press, Inc Ebook. The Basic Hemofilter Renal Replacement Physiology Solute and fluid clearance are achieved by either diffusion or convection Require sequestration of blood on one side of a semi-permeable membrane Diffusive clearance solute moves down its concentration gradient / Convective clearance utilizes a pressure gradient rather than concentration gradient Waters,P. CRRT Review and Refresh. Retrieved from Fleming, et al. Organogenesis Jan-Mar;7(1):2-12. Renal Replacement Physiology Diffusion Diffusive clearance more effective at removal of small to medium-sized solutes Higher molecular weight will have lower rates of diffusion Passing fluid countercurrent to blood flow; equilibration of plasma and dialysate solute concentrations occur Improvements with introduction of high-flux semipermeable membranes Tolwani et al N Engl J Med 2012;367: Renal Replacement Physiology Convection Convection main effect is on water movement with solute movement in conjunction with water Transmembrane pressure difference is increased as needed to push water through the membrane Small solute removal similar to diffusion, fluid and a larger particle removal is far superior with convective clearance Clearance is limited by characteristics of the membrane Tolwani et al N Engl J Med 2012;367:

4 Fluids used in CRRT CRRT modes - SCUF Dialysate fluid Necessary for DIFFUSION Increasing dialysate rate = increasing diffusion gradient across the membrane improving solute removal Removal of small to medium sized molecules Large molecules diffuse slowly Replacement Fluid Typically do NOT replace anything! Used to increase CONVECTION Pre-filter vs. post-filter Saline used most commonly +/- additives Caution adding calcium to the replacement fluid with CITRATE anticoagulation-> neutralize citrate + clog filter SCUF: slow continuous ultrafiltration No dialysate or replacement fluid Solvent removed via convection Solute pushed through membrane via solvent drag Indication: fluid removal without uremia or electrolyte imbalances Waters P. CRRT Review and Refresh. Retrieved from April 28, CRRT modes - CVVH CRRT modes - CVVHD CVVH: continuous venovenous hemofiltration No dialysate fluid Replacement fluid either pre or post filter Indication: removal of uremia and/or electrolyte and ph imbalances Convection = removal of small, medium, + large molecules Ultrafiltration via pressure gradient (TMP) CVVHD: continuous venovenous hemodialysis Dialysate fluid necessary Concentration gradient No replacement fluid Diffusion= removal of small to medium sized molecules Large molecules diffuse slowly April 28, April 28, CRRT modes - CVVHDF CVVHDF: continuous venovenous hemodiafiltration Dialysate fluid Replacement fluid pre or post filter Flexible mode = diffusion and convection! Optimal Renal Replacement Strategy The optimal method of RRT in critically ill is controversial There is no mortality benefit of CRRT compared to IHD No definitive data exist to support one therapy over the other Hemodynamic stability with IHD in critically ill patients is a major concern _of_continuous_renal_replacement_therapy_technical_and_c linical_considerations April 28, Joy et al Ann Pharmacother Mar;32(3): Tolwani et al N Engl J Med 2012;367:

5 Continuous v. Intermittent Dialysis Abdul Rauf et al patients included Retrospective cohort In-hospital mortality 30% in the IHD group and 48% in the CRRT group Renal recovery 44% in the IHD group and 39% in the CRRT group Total costs were, on average,$51, 556 less for patients undergoing IHD Total costs of care may significantly differ by method of RRT despite similar patient outcomes Continuous v. Intermittent Dialysis OUTCOMEREA Trial patients included Prospective observational multicenter cohort database 30 day mortality 35.0 % in the IHD group and 46.5 % in the CRRT group Dialysis dependency at day % in the IHD group and 21.8 % in the CRRT group RRT modality has little influence on both survival and renal outcome at 30 days and 6 months Rauf et al J Intensive Care Med May-Jun;23(3): Truche et al Intensive Care Med (2016) 42: Anticoagulation Practices vary by modality and local patterns Systemic heparinization remains the mainstay of anticoagulation for IHD and CRRT Citrate regional anticoagulation has gained significant popularity Heparin or citrate use prolongs filter life compared to no anticoagulation in CRRT Anticoagulation Necessary to de-activate the clotting cascade once blood reaches non-endothelial surfaces of tubing and filter Longer-lasting filters = reduced time OFF therapy and potential adverse events Systemic unfractionated heparin Advantage in patients who also have an indication for its use: DVT or valve? Monitor aptt or ACT Regional Citrate (ACD-A) Infused pre-filter -> chelates calcium to inhibit coagulation Monitor post-filter ica for adjusting ACD rate (ica of machine: mmol/L) Requires calcium infusion to patient (ica of patient: mmol/L) Monitor for metabolic acidosis or alkalosis Monitor for Citrate Lock Oudemans-van Straaten et al. Critical Care 2011, 15:202 Bunchman, T. Hemofiltration-Overview. Retrieved from Waters P. CRRT Review and Refresh. Retrieved from Citrate versus Heparin Factor Unfractionated Sodium Citrate Heparin Anticoagulation Regional and systemic Regional Risk of bleeding Higher Not increased Circuit life Shorter Longer Metabolic Derangements None Greater risk if not well controlled Complications Heparin-induced Calcium depletion thrombocytopenia Population Low risk of bleeding Surgical Septic Organ failure Oudemans-van Straaten et al. Critical Care 2011, 15:202 Citrate versus Heparin Studies evaluating heparin anticoagulation for CRRT are too small for a robust evaluation The benefit of citrate extends beyond a reduction in bleeding Citrate appears to have better outcomes than heparin There is a need for a better understanding of citrate anticoagulation and its challenges Oudemans-van Straaten et al. Critical Care 2011, 15:202 5

6 Anticoagulation Results: Hemofilter survival was higher in the citrate group than in the heparin group (72 vs. 18 h; p <0.0001). Bivariate analysis showed that the hemofilter coagulation risk was significantly increased when heparin was used, regardless of hemofilter size and pump flow (hazard ratio 3.70, standard error 0.82, 95% confidence interval ; p < ). Conclusions: Regional citrate anticoagulation could be more effective than heparin systemic anticoagulation to prolong filter lifetime Dialyzable Properties - Drug Only drug in the central compartment is available for extracorporeal removal Molecular Weight Molecular weight is inversely related to clearance Volume of Distribution Large Vd, minimally dialyzed (> L/kg) Protein binding Increased protein binding = less free/unbound drug in serum for removal (> 80%) Solubility Hydrophilicity vs. lipophilicity Drugs cleared extensively (> 65% of total drug clearance) by nonrenal pathways are less likely to be cleared Vetlri M, et al. Pediatr Drugs 2004; 6 (1): Dialyzable Properties - Device Only drug in the central compartment is available for extracorporeal removal Membrane adsorption High sieving coefficient Charge ph Filter M60, M100, M150 Porosity, Surface area Blood, Dialysate, and Ultrafiltration flow rates Sc (sieving coefficient) Dialyzable Properties - Filter Semi-permeable membranes: Allows easy transfer of solutes < 100 daltons Impermeable to albumin and solutes > 50,000 Daltons CVVH membranes: straight channels, large diameter, less resistance to flow Adsorption onto filters is saturable and varies according to the timing of filter changes: Adsorption immediately after a filter change will be greater Effects saturation + sieving coefficients Drug clearance higher initially, then adsorptive surface area declines, clearance declines Measuring drug concentrations near the time of a filter change may alter estimates of clearance Low vs. high flux filters result in variable drug clearance Veltri M, et al. Pediatr Drugs 2004; 6 (1): Walters S, et al. Pediatr Nephrol (2009) 24:37 48 Veltri M, et al. Pediatr Drugs 2004; 6 (1): Dialyzable Properties April 28, Zuppa A, et al. Clin Pharmacol 2012;52:134S-140S 6

7 Modality Considerations CRRT yields drug clearance similar to an analogous GFR of the native kidneys Combined dialysate and ultrafiltration flow rates have been recommended as a rough estimate of CrCl Drug clearance by pumped CRRT is slow yet constant The extent of drug clearance can be dependent of the on pharmacologic and technical dialyzable properties Churchwell et al Semin Dial Mar-Apr;22(2):185-8 Schetz Curr Opin Crit Care 13: Patient Specific Considerations Hypothermia? Sepsis? Hypoxemia? Cardiac failure? MODS*? Drug metabolism in patients with AKI can be quite different from what is observed in healthy patients The longer patients remain on CRRT, drug clearance can be significantly reduced *MODS = multiple organ dysfunction syndrome Joy et al Ann Pharmacother 1998;32: Churchwell et al Semin Dial Mar-Apr;22(2):185-8 Schetz Curr Opin Crit Care 13: Veltri M, et al. Pediatr Drugs 2004; 6 (1): O Meara M. 2015, July 18. Pharmacokinetic Parameters & Drug Handling in Continuous Renal Replacement Therapy (CRRT). Retrieved from Medication Considerations-Major concepts All CRRT methods are not created equal Convective therapies usually have superior solute clearance Clearance differences become larger as the flow rates and MW increases Medication Dosing Several alternative approaches to drug dosing Drug properties Total creatinine clearance Clinical effect Drug levels Data is limited and mostly not generalizable because heterogeneity of patient population Achieve an estimated creatinine clearance of 25 to 50 ml/min Dose medications per sum of extracorporeal and endogenous CrCl CRRT drug dosing guidance has always been lacking for clinicians Joy et al Ann Pharmacother 1998;32: Churchwell et al Semin Dial Mar-Apr;22(2):185-8 Churchwell et al Semin Dial Mar-Apr;22(2):185-8 Schetz Curr Opin Crit Care 13: Medication Dosing: Antimicrobials Specific antimicrobial dosing recommendations for various forms of dialysis Patients on CRRT are susceptible to suboptimal antimicrobial target attainment Larger and/or more frequent dosing may be necessary, relative to dosing regimens Factors Affecting Antimicrobial Dosing in Critically Ill Patients Type of dialysis Intrinsic renal function Site of infection Severity of infection Drug removal for most antimicrobials is largely affected May clear more drug than predicted by dialysis alone Deep-seated infections require larger doses Aggressive dosing should be used for severe infections Patient size Larger patients may require larger doses Antimicrobial factors Absorption, distribution, metabolism, and elimination Drug-drug interactions May alter antimicrobial absorption, distribution, metabolism, and elimination Kempke AP et al. Crit Care Res Pract. (2016) Heintz et al Pharmacotherapy May;29(5): Heintz et al Pharmacotherapy May;29(5):

8 Recommended Adult Antimicrobial Dosages by Type of CRRT Drug Loading Dose CVVH CVVHD CVVHDF IHD Ampicillinsulbactam 3g g q8 12h g q8h g q6 8h g q12 24h Cefazolin 2g 1 2 g 1 g q8h or 2g 1 g q8h or 2g mg q24h Cefepime 2g 1 2 g 1 g q8h or 2g 1 g q8h or 2g mg q24h Ceftazidime 2g 1 2 g 1 g q8h or 2g 1 g q8h or 2g mg q24h Colistin mg/kg q48h 2.5 mg/kg q48h 2.5 mg/kg q48h 1.5 mg/kg q24 48h Meropenem 1g 0.5 1g g q8 12h g q8 12h 500 mg q24h Piperacillintazobactam g q g q6h g q6h 2.25 g q8 12h 8h Vancomycin mg/kg mg/kg mg/kg mg/kg 5-10mg/kg after Q24-48h q24h HD Heintz et al Pharmacotherapy May;29(5): Medication Dosing: Antimicrobials Do not require dosing adjustment during CRRT Amphotericin B Azithromycin Caspofungin Ceftriaxone Clindamycin Erythromycin Fosfomycin Linezolid Heintz et al Pharmacotherapy May;29(5): Metronidazole Nafcillin Posaconazole Rifampin Tigecycline Voriconazole Medication Dosing: Anti-epileptics Surprisingly little data regarding extracorporeal removal of AEDs in various RRT methods Consider the qualities of medications likely to be removed by RRT Low V D < 80% plasma protein binding MW < 50,000 Daltons AEDs that are primarily hepatically eliminated less likely to require adjustments Antiepileptic of removal by CRRT modality and empiric dosing strategies Drug Reference Range Carbamazepine 4-12 Lacosamide 5-10 Lamotrigine 3-14 Levetiracetam 6-20 CVVH CVVHD CVVHD F Empiric Dose _ ± mg every 6 h mg/day ± ± + 25mg daily mg Smetana et al J Crit Care Dec;36: Smetana et al J Crit Care Dec;36: Antiepileptic of removal by CRRT modality and empiric dosing strategies Drug Reference Range Phenobarbital Phenytoin CVVH CVVHD CVVHDF Empiric Dose mg/kg per day ± ± ± 5-7mg/kg per day Medication Dosing Protocols in CRRT Medication Hospital 1 Hospital 2 Hospital 3 CrCl < 30mL/min Specifies type of CRRT Yes No No -- Ampicillin/Sulbactam 3g every 8 3g every g every g every 8 Cefazolin 1-2g every 8 2g every 12 2g every g every 8 Valproic acid Zonisamide ± mg/kg q8h mg daily Cefepime 1g every 8 2g every 12 2g every 12 1g every 8 Daptomycin Every 48 Every 48 Every 24 Every 48 Smetana et al J Crit Care Dec;36:

9 Medication Dosing Protocols in CRRT Medication Hospital 1 Hospital 2 Hospital 3 CrCl < 30mL/min Fluconazole 400mg every mg every mg every mg every 24 Meropenem 500mg every 6 2g every mg every 6 500mg Q8H Piperacillin/ tazobactam Trimethoprim/ Sulfamethoxazole 3.375g every every every g every 6 5mg/kg every 8 7.5mg/kg every mg/kg every 8 5mg/kg every 8 Pediatric Renal Dosing Recommendations Drug Molecular Weight Protein Binding Normal Dose CRRT Acyclovir daltons < 33% 5-20 mg/kg/dose IV q mg/kg/dose IV q24h ( = encephalitis) Cefotaxime daltons 27-40% mg/kg/dose IV q8h-q6h mg/kg/dose IV vs mg/kg/dose IV q8h Cefepime daltons 20% 50 mg/kg/dose IV q12-q8h 50 mg/kg/dose IV Levetiracetam daltons < 25% 10 mg/kg/dose IV up to 60 mg/kg/day divided q8h 50% dose reduction from normal dose; levels Ranitidine daltons ~15% mg/kg/dose IV q8-q6h 1 mg/kg/dose IV Meropenem daltons ~2% mg/kg/dose IV q8h mg/kg/dose IV Seminars in Dialysis. 2011;24(1):50 55 Lexicomp Online, Pediatric and Neonatal Lexi-Drugs Online, Hudson, Ohio: Wolters Kluwer Clinical Drug Information, Inc Vettri M, et al. Pediatr Drugs 2004; 6 (1): Aronoff GR, Bennett WM, Berns JS, et al. Drug Prescribing in Renal Failure. 5th ed. Philadelphia, PA: American College of Physicians; Pediatric Dose Adjustments Pharmacokinetics Gentamicin Vancomycin Phenobarbital Oxcarbazepine Protein Binding < 30% 30-55% 30-60% 40-67% Volume of L/kg L/kg L/kg 0.7 L/kg Distribution Metabolism Hepatic Hepatic Medication Dose Strategies Drug Dosing During Continuous Renal Replacement Therapies J Pediatr Pharmacol Ther 2008 Vol. 13 No. 2 Excretion Renal / Reduced clearance Notes Additional clinical status changes altering Vd Supplemental doses during IHD Dose 2-3 mg/kg/dose -> levels Renal / Reduced Renal / Increased Renal / Reduced clearance clearance clearance? In CRRT, caution Largely removed MHD and under-dosing during CRRT glucuronide metabolites can In IHD: Moderately removed accumulate in Loading dose during IHD -> renal failure dialysis postdialysis level pre- may be needed IS removed Supplemental doses dialysis level -> dialysis during IHD new post-dialysis dose? mg/kg -> levels 10 mg/kg q8-6h 50% dose reduction? Veltri M, et al. Pediatr Drugs 2004; 6 (1): Seminars in Dialysis. 2011;24(1):50 55 Vettri M, et al. Pediatr Drugs 2004; 6 (1): Eur J Clin Pharmacol. 1994;47(2):161-7 Summary FSHP Acute kidney Injury is a common occurrence in adult and pediatric critically ill patients In pediatrics no one size fits all approach Scant pediatric data detailing and describing how machine parameters (blood flow, dialysate flow rate, ultrafiltration rate, or type of membrane) alter drug clearance Medication clearance can vary depending on the type of CRRT utilized Understanding the specifics of the equipment at your institution can assist clinicians with estimating medication clearance optimize pharmaceutical care to your patients Therapeutic drug monitoring and pharmacokinetic calculations are key Medication Considerations for the Adult/Pediatric ICU Patient Receiving Renal Replacement Therapy Calvin Tucker, PharmD, BCPS, BCCCP Julianna Crain, PharmD, BCPPS, AE-C 9

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