PERITONEAL DIALYSIS PRESCRIPTION MANAGEMENT QUICK REFERENCE GUIDE

Transcription

1 PERITONEAL DIALYSIS PRESCRIPTION MANAGEMENT QUICK REFERENCE GUIDE

2 This quick reference guide will help serve as a reference tool for clinicians setting a patient s Peritoneal Dialysis (PD) prescription. Sample dialysis prescriptions are based on Volume of Urea Distribution (V urea ), Residual Kidney Function (RKF) and Peritoneal Membrane Type. The sample prescriptions are intended as an aid in achieving recommended clearance goals; however, other prescription options may also exist. If a patient develops any of the following: uremic symptoms, decline in nutritional status and/ or decreased measured clearances, then a more precise prescription based on patient-specific parameters and using prescription management software is recommended. This prescription management tool is for informational purposes only and should not be considered medical advice. It contains sample PD prescriptions for average patients of various cohorts with specified ranges of V urea peritoneal transport type and residual kidney function. These prescriptions are for initial and subsequent therapy, are provided for informational purposes only and should not be substituted for individual clinical judgement. This guide is not intended to be the practice of medicine, nor does it replace medical clinical judgment. By its nature, this guide cannot be considered to be exhaustive, and users are encouraged to pursue specific issues that may not be covered herein. TABLE OF CONTENTS Adequacy and Ultrafiltration Goals...3 Volume of Distribution of Urea (V urea )...3 Volume of Urea Distribution: 55-Year-Old Male... 4 Volume of Urea Distribution: Female...5 PET Calculations...6 Assessment for Initial Prescription...7 Preliminary Assessment of Drain Volume...8 Individualizing the Therapy...8 Assumptions on Which Modeling is Based...9 Suggested Prescriptions for Patients with/without Residual Kidney Urea Clearance...10 EXTRANEAL (icodextrin) PD Solution Indications and Important Risk Information References...13 Please see Indications and Important Risk Information, including Boxed Warning for EXTRANEAL (icodextrin) PD Solution on page 12. See for Full Prescribing Information. TABLE OF CONTENTS 2

3 ADEQUACY AND ULTRAFILTRATION GOALS The minimum delivered weekly Kt/V urea of 1.7 represents peritoneal clearance alone or peritoneal plus renal clearance 1 While the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines do not recommend use of creatinine clearance to assess adequacy, creatinine clearance goals of 45 L/wk in APD patients are advocated by the International Society of Peritoneal Dialysis (ISPD) and other organizations 1 6 Euvolemia is critical to improve patient outcomes 1 While no recommendation regarding an ultrafiltration (UF) target exists in the United States, other countries recommend an arbitrary UF target of ml/day in anuric patients, based upon 4, 5, 7 improved outcomes in observational studies VOLUME OF DISTRIBUTION OF UREA (V UREA ) A simple method for determining the volume of urea distribution is to estimate the patient s total body water (TBW). It is important to note that different equations exist for estimating total body water, and using a different equation may give different values. The anthropometric volume of distribution of urea may be calculated by one of the following formulas based on age, height, weight and gender. These are derived from estimates of total body water in healthy subjects. WATSON AND WATSON: 8 Male TBW = ( x age [years]) + ( x height [cm]) + ( x weight [kg]) Female TBW = ( x height [cm]) + ( x weight [kg]) HUME- WEYERS: 9 Male TBW = ( x height [cm]) + ( x weight [kg]) Female TBW = ( x height [cm]) + ( x weight [kg]) Adequacy and Ultrafiltration GOALS / Volume of Distribution of Urea (Vurea) 3

4 VOLUME OF UREA DISTRIBUTION: 55-YEAR-OLD MALE * *For every 10-year increase in age, decrease volume by 1L for males. *For every 10-year decrease in age, increase volume by 1L for males. n V < 34 L (small) n 34 L V < 42 L (medium) n V 42 L (large) WEIGHT HEIGHT (CM) (KG) n V < 34 L (small) n 34 L V < 42 L (medium) n V 42 L (large) Volume of Urea Distribution: 55-Year-OLD 4

5 VOLUME OF UREA DISTRIBUTION: FEMALE Only one table is used for females because age has no effect on the calculations 8,16 n V < 34 L (small) n 34 L V < 42 L (medium) n V 42 L (large) WEIGHT HEIGHT (CM) (KG) n V < 34 L (small) n 34 L V < 42 L (medium) n V 42 L (large) Volume of Urea Distribution: FEMALE 5

6 PET CALCULATIONS 10 D/P CREATININE = *Corrected Dialysate Creatinine Concentration at 0-hr, 2-hr, 4-hr Dwell Plasma Creatinine Concentration at 2-hr Dwell D/D 0 GLUCOSE = Dialysate Glucose Concentration at 2-hr and 4-hr Dwell Dialysate Glucose Concentration at 0-hr Dwell *If nonenzymatic method (i.e. picric acid assay) is used for analysis of creatinine, be sure to use correction factor to accurately estimate creatinine value. D/P Creatinine D/D 0 Glucose HIGH HIGH-AVERAGE LOW-AVERAGE LOW LOW LOW-AVERAGE HIGH-AVERAGE HIGH HOURS HOURS Membrane Transport Type 4-hour D/P Creatinine HIGH HIGH-AVERAGE LOW-AVERAGE LOW If discordance in D/P creatinine and D/D 0 glucose is noted, it is recommended to repeat the PET. Clinical assessment must be taken into account if results remain discordant. 10 Permission to use chart: Twardowski ZJ, Clinical Value of Standardized Equilibration Test in CAPD Patients, Current Concepts of CAPD, Blood Purif 1989;7: PET Calculations 6

7 ASSESSMENT FOR INITIAL PRESCRIPTION ASSESSMENT FOR INITIAL PRESCRIPTION VOLUME OF UREA DISTRIBUTION (small, medium, large) CLINICAL AND NUTRITIONAL ASSESSMENT ESTIMATED RESIDUAL KIDNEY FUNCTION (RKF) INITIAL MEMBRANE EVALUATION THROUGH ASSESSMENT OF DRAIN VOLUME LIFESTYLE, SOCIAL AND PSYCHOLOGICAL CONSIDERATIONS See page 8 SET INITIAL PRESCRIPTION CAPD* 11 APD* exchanges/day x L fill volume (Dependent on RKF) APD CYCLER 3-4 exchanges/night x L fill volume Total cycler time 7-10 hours (Dependent on RKF) DAYTIME EXCHANGES 0-1 exchange/day x L fill volume (Dependent on RKF) * If significant RKF, prescription requirements may be less. 12 Unless a preliminary PET is performed, the initial prescription should be based on assumptions of average membrane type. assessment for initial prescription 7

8 PRELIMINARY ASSESSMENT OF DRAIN VOLUME Unless a preliminary PET is performed, the initial prescription should be based on assumptions of average membrane type. Initial membrane assessment and ultrafiltration response to dextrose: Use 2.5% dextrose, 2.0 L fill volume and at 4 hours, assess drain volume to crudely estimate membrane transport type. 13 MEMBRANE TRANSPORT TYPE HIGH HIGH-AVERAGE LOW-AVERAGE LOW DRAIN VOLUME* ml ml ml ml *Mean for all transport types is 2368 ml Note: In diabetic patients with high serum glucose levels (>300 mg/dl), the results of the drain volume are not useful for patient categorization and inconsistent with creatinine values. 13 INDIVIDUALIZING THE THERAPY 14 L (D/P < 0.5) LA (D/P ) HA (D/P ) H (D/P > 0.81) Small (V urea < 34L) INCREASE NUMBER OF EXCHANGES Medium (34L V urea < 42L) Large (V urea 41L) INCREASE FILL VOLUME Figure illustrates the need to augment the number of exchanges as D/P creatinine increases and to increase fill volume with increase in V urea. preliminary assessment of drain volume / individualizing the therapy 8

9 ASSUMPTIONS ON WHICH MODELING IS BASED Data from 1,006 randomly selected adult PD patients from 39 U.S. centers were analyzed and used to group patients according to their peritoneal membrane transport characteristics and V urea. Based on four PET classifications and three V urea categories, modeling was performed on PD ADEQUEST software to obtain prescriptions that would meet or exceed minimum adequacy and UF goals. 11 Clearance goals have been subject to multiple revisions. The sample prescriptions provided in this guide were designed to achieve a minimum weekly delivered Kt/V of 1.7 and to minimize patient burden. The sample prescriptions must not be considered medical advice and are not a substitute for clinical judgement. 11 Minimal Delivered Weekly Clearance Goal: Kt/V Continuous Therapy: Fluid in peritoneal cavity seven days/week 11 Ultrafiltration: 1.0 L/day. Adjustment of dialysis solutions including dextrose and EXTRANEAL (icodextrin) PD Solution to meet the patient s UF requirement is necessary. UF plays an important role in obtaining clearance. Increasing or decreasing UF also impacts clearance 11 Residual Kidney Function: For patients with 2 ml/min of RKF, prescriptions are based on kidney urea clearance 11 CAPD: 8-hour overnight exchange 11 11, 15 APD: 9-hour cycler time A glucose-sparing strategy, using 1.5% and 2.5% dextrose solutions, was applied in modeling. Under these modeling assumptions, use of 4.25% was therefore precluded. However, 4.25% dextrose solutions can be used in situations of fluid overload 11 Please note: The following tables contain sample prescriptions based on patient categories. These are provided for informational purposes only and should not be considered medical advice nor should they be substituted for individual clinical judgement. It is important that you obtain a 24-hour urine and dialysate collection so that the delivered dose is at your goal and adjust the prescription accordingly. If one were to model the prescription, there would be many other prescription options you may want to consider. PD ADEQUEST software is a clinical tool that organizes dialysis therapy data to facilitate clinical decision making and patient care. It is in no way intended to be a substitute for clinical practice or a patient chart. Assumptions on Which Modeling Is BASED 9

10 SUGGESTED PRESCRIPTIONS FOR PATIENTS WITH RESIDUAL KIDNEY UREA CLEARANCE < 2 ML/MIN *12 Kinetic modeling was performed using PD ADEQUEST software to create the tables below. Recommended dialysis prescriptions are intended to achieve a desired Kt/V urea of 1.7 and a minimum ultrafiltration of 1000 ml/day. To illustrate that modeling can be designed around additional targeted objectives, use of 4.25% dextrose was omitted in these examples to avoid excessive glucose exposure. Only PD solutions containing dextrose concentrations of 1.5% and 2.5% were used in the modeling process while additional prescriptions were created using EXTRANEAL (icodextrin) PD Solution in the long dwell. An extra daytime exchange (in addition to the last bag fill) was also included in selected situations to help augment clearance and ultrafiltration results for motivated patients as needed. Nine hour overnight treatments periods were considered for the APD prescriptions. Irrespective of modeling, clinical judgment must always be employed in order to create individualized prescriptions that meet patients specific urea clearance, ultrafiltration, medical and lifestyle needs. 1.5%/2.5% dextrose dialysis solutions 2.5% dextrose dialysis solutions EXTRANEAL (icodextrin) PD Solution used in the long dwell period LOW TRANSPORT LOW-AVERAGE TRANSPORT HIGH-AVERAGE TRANSPORT HIGH TRANSPORT NIGHT DAY NIGHT DAY NIGHT DAY NIGHT DAY V1 <34L (SMALL) APD 5x2L 2L APD 4x2.5L 2L APD 5x2L 2L APD 4x2L 2x2L 3x2L 2x2L 4x2L 2x2L 3x2L 2L 3x2L 2L 4x2L 2L 3x2.5L 2x2L 3x2.5L 2.5L 4x2L 2L CAPD 2L 3x2L CAPD 2L 3x2L CAPD 2L 3x2L CAPD 2.5L 3x2L 1.5L 4x1.5L 1.5L 4x1.5L 1.5L 4x1.5L 2L 3x2L 2L 3x2L V2 34 L V < 42 L (MEDIUM) APD 3x3L 2x2.5L APD 3x2.5L 2x2L APD 4x2L 2x2L APD 4x2.5L 2x2.5L 4x2.5L 2x2.5L 4x3L 3L 5x2.5L 2.5L 5x2.5L 2x2.5L 4x2.5L 2.5L 5x2L 2L 4x2.5L 2.5L 5x2.5L 2L CAPD 3L 3x3L CAPD 2.5L 3x2.5L CAPD 2.5L 3x2.5L CAPD 3L 3x3L 2.5L 4x2.5L 2.5L 3x2.5L 2.5L 4x2.5L 2.5L 3x2.5L V3 V 42 L (LARGE) APD 3x3L 2x3L APD 5x2.5L 2x2.5L APD 4x2.5L 2x2.5L APD 4x2.5L 2x2.5L 4x3L 2x2.5L 3x3L 2x3L 4x3L 2x2.5L 5x2.5L 2.5L 4x3L 2x2.5L CAPD 3L 4x3L CAPD 3L 4x3L CAPD 3L 4x3L CAPD 3L 4x3L 2.5L 4x2.5L * Lower concentrations of dextrose and/or a fewer number of exchanges than indicated here may be needed to achieve total UF targets and euvolemia in the setting of substantial volume output by the kidneys. Please see Indications and Important Risk Information, including Boxed Warning for EXTRANEAL (icodextrin) PD Solution on page 12. See for Full Prescribing Information. Suggested Prescriptions for Patients with/without Residual Kidney Urea Clearance 10

11 SUGGESTED PRESCRIPTIONS FOR PATIENTS WITH RESIDUAL KIDNEY UREA CLEARANCE 2 ML/MIN *12 Kinetic modeling was performed using PD ADEQUEST software to create the tables below. Recommended dialysis prescriptions are intended to achieve a desired Kt/V urea of 1.7 and a minimum ultrafiltration of 1000 ml/day. To illustrate that modeling can be designed around additional targeted objectives, use of 4.25% dextrose was omitted in these examples to avoid excessive glucose exposure. Only PD solutions containing dextrose concentrations of 1.5% and 2.5% were used in the modeling process while additional prescriptions were created using EXTRANEAL (icodextrin) PD Solution in the long dwell. An extra daytime exchange (in addition to the last bag fill) was also included in selected situations to help augment clearance and ultrafiltration results for motivated patients as needed. Nine hour overnight treatments periods were considered for the APD prescriptions. Irrespective of modeling, clinical judgment must always be employed in order to create individualized prescriptions that meet patients specific urea clearance, ultrafiltration, medical and lifestyle needs. 1.5%/2.5% dextrose dialysis solutions 2.5% dextrose dialysis solutions EXTRANEAL (icodextrin) PD Solution used in the long dwell period LOW TRANSPORT LOW-AVERAGE TRANSPORT HIGH-AVERAGE TRANSPORT HIGH TRANSPORT NIGHT DAY NIGHT DAY NIGHT DAY NIGHT DAY V1 <34L (SMALL) APD 3x1.5L 1.5L APD 4x2L 2L APD 3x2L 2x2L APD 4x2L 2x2L 3x2L 2L 3x2L 2L 5x2L 2L 3x2L 2L 4x2L dry 3x2L 2L CAPD 1.5L 3x1.5L CAPD 1.5L 3x1.5L CAPD 2L 3x2L CAPD 2.5L 3x2.5L 2L 3x2L 2L 3x2L 2L 3x2L 2L 3x2L V2 34 L V < 42 L (MEDIUM) APD 3x2.5L 2.5L APD 3x2.5L 2L APD 3x2L 2x2L APD 3x2.5L 2x2.5L 5x2L 2L 3x2.5L 2x2L 5x2L 2L 3x2L 2L 4x2.5L 2L 3x2L 2L 3x2L 2L 3x2L 2L 4x2L 2L CAPD 2L 3x2L CAPD 2L 3x2L CAPD 2L 3x2L CAPD 3L 3x3L 2L 3x2L 2L 3x2L 3L 4x3L 2.5L 3x2.5L V3 V 42 L (LARGE) APD 4x3L 2.5L APD 3x3L 2x2.5L APD 4x2.5L 2x2L APD 3x2.5L 2x2.5L 3x2L 2x2L 4x3L 2x3L 5x2.5L 2.5L 4x2.5L 2L 4x2.5L 2.5L 3x2.5L 2x2.5L 4x2.5L 2.5L 3x3L 2L 4x2.5L 2.5L 5x2.5L 2L 3x3L 2.5L CAPD 2.5L 3x2.5L CAPD 2.5L 3x2.5L CAPD 2.5L 3x2.5L CAPD 3L 3x3L 2.5L 3x2L 2.5L 3x2.5L 2.5L 3x2.5L 2.5L 4x2.5L 2.5L 3x2.5L * Lower concentrations of dextrose and/or a fewer number of exchanges than indicated here may be needed to achieve total UF targets and euvolemia in the setting of substantial volume output by the kidneys. Please see Indications and Important Risk Information, including Boxed Warning for EXTRANEAL (icodextrin) PD Solution on page 12. See for Full Prescribing Information. Suggested Prescriptions for Patients with/without Residual Kidney Urea Clearance 11

12 INDICATIONS EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of end-stage renal disease. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET). IMPORTANT RISK INFORMATION WARNING: UNRECOGNIZED HYPOGLYCEMIA RESULTING FROM DRUG-DEVICE INTERACTION Only use glucose-specific monitors and test strips to measure blood glucose levels in patients using EXTRANEAL (icodextrin) Peritoneal Dialysis Solution. Blood glucose monitoring devices using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase (GDO)- based methods must not be used. In addition, some blood glucose monitoring systems using glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD)-based methods must not be used. Use of GDH- PQQ, GDO, and GDH-FAD-based glucose monitors and test strips has resulted in falsely elevated glucose readings (due to the presence of maltose). Falsely elevated glucose readings have led patients or health care providers to withhold treatment of hypoglycemia or to administer insulin inappropriately. Both of these situations have resulted in unrecognized hypoglycemia, which has led to loss of consciousness, coma, permanent neurological damage, and death. Plasma levels of EXTRANEAL (icodextrin) and its metabolites return to baseline within approximately 14 days following cessation of EXTRANEAL (icodextrin) administration. Therefore, falsely elevated glucose levels may be measured up to two weeks following cessation of EXTRANEAL (icodextrin) therapy when GDH-PQQ, GDO, and GDH-FAD-based blood glucose monitors and test strips are used. To avoid improper insulin administration, educate all patients to alert health care providers of this interaction particularly in hospital settings. The manufacturer(s) of the monitor and test strips should be contacted to determine if icodextrin or maltose causes interference or falsely elevated glucose readings. For a list of toll free numbers for glucose monitor and test strip manufacturers, please contact the Baxter Renal Clinical Help Line RENAL-HELP or visit Because of the risk of unrecognized hypoglycemia that could result from a drug-device interaction, EXTRANEAL is available only through a restricted program. EXTRANEAL (icodextrin) is contraindicated in patients with a known allergy to cornstarch or icodextrin, in patients with maltose or isomaltose intolerance, in patients with glycogen storage disease, and in patients with severe lactic acidosis. EXTRANEAL is intended for intraperitoneal administration only. Not for intravenous injection. Aseptic technique should be used throughout the peritoneal dialysis procedure. Encapsulating peritoneal sclerosis (EPS), sometimes fatal, is a complication of peritoneal dialysis therapy and has been reported in patients using EXTRANEAL. Serious hypersensitivity reactions to EXTRANEAL have been reported such as toxic epidermal necrolysis, angioedema, serum sickness, erythema multiforme and vasculitis. Anaphylactic or anaphylactoid reactions may occur. If a serious reaction is suspected, discontinue EXTRANEAL immediately and institute appropriate therapeutic countermeasures. Overinfusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominal distention, feeling of fullness and/or shortness of breath. Drain the peritoneal dialysis solution from the peritoneal cavity to treat overinfusion. Patients with insulin-dependent diabetes may require modification of insulin dosage following initiation of treatment with EXTRANEAL. Monitor blood glucose and adjust insulin, if needed. Peritoneal dialysis may affect a patient s protein, water-soluble vitamin, potassium, sodium, chloride, bicarbonate, and magnesium levels and volume status. Monitor electrolytes and blood chemistry periodically. Monitor fluid status to avoid hyper- or hypovolemia and potentially severe consequences including congestive heart failure, volume depletion, and hypovolemic shock. Abnormalities in any of these parameters should be treated promptly under the care of a physician. In clinical trials, the most frequently reported adverse events occurring in 10% of patients and more common in EXTRANEAL PD solution patients than in control patients, were peritonitis, upper respiratory infection, hypertension, and rash. The most common treatment-related adverse reaction for EXTRANEAL PD solution patients was skin rash. Please see or for Full Prescribing Information. EXTRANEAL (icodextrin) PD Solution INDICATIONS AND Important Risk Information 12

13 REFERENCES 1. National Kidney Foundation. K/DOQI clinical practice guidelines and clinical practice recommendations for 2006 updates: Hemodialysis adequacy, peritoneal dialysis adequacy and vascular access. Am J Kidney Dis. 2006;48 (Suppl 1):S1-S Blake PG, Bargman JM, Brimble KS, et al. Canadian society of nephrology guidelines/ recommendations: Clinical practice guidelines and recommendations on peritoneal dialysis adequacy Perit Dial Int. 2011;31: Lo WK, Bargman JM, Burkart J, et al. Guideline on targets for solute and fluid removal in adult patients on chronic peritoneal dialysis. Perit Dial Int. 2006;26: European best practice guidelines for peritoneal dialysis. Nephrol Dial Transplant. 2005;20 (Suppl 9):ix1-ix UK Renal Association clinical practice guidelines 6th edition :1-41. Accessed June 20, CARI (Caring for Australians with Renal Impairment) dialysis adequacy (PD) guidelines :1-13. Accessed August 19, Brown EA, Davies SJ, Rutherford P, et al. Survival of functionally anuric patients on automated peritoneal dialysis:the European APD outcome study. J Am Soc Nephrol. 2003;14: Watson PE, Watson ID, Batt RD. Total body water volumes for adult males and females estimated from simple anthropometric measurements. Amer J Clin Nutrition. 1980;33: Hume R, Weyers E. Relationship between total body water and surface area in normal and obese subjects. J Clin Path. 1971;24: Twardowski ZJ. Clinical value of standardized equilibration tests in CAPD patients. Blood Purif. 1989;7: Data on file kinetic modeling Baxter Healthcare Corp Vonesh EF, Burkart J, McMurray SD & Williams PF. Peritoneal dialysis kinetic modeling: Validation in a multicenter clinical study. Perit Dial Int. 1996;16: Twardowski ZJ. The fast peritoneal equilibration test. Semin Dial 1990;3: Blake P, Burkart JM, Churchill DN, et al. Recommended clinical practices for maximizing peritoneal dialysis clearance. Perit Dial Int. 1996;16: Mujais S, Childers RW. Profiles of automated peritoneal dialysis prescriptions in the US Kidney Int. 2006;70:S84-S Data on file volume of distribution of urea. Baxter Healthcare Corp References 13

14 Baxter, Extraneal and PD Adequest are trademarks of Baxter International Inc. USMP/81/ /17