Guideline for the use of. Renastart in infants

Transcription

1 Guideline for the use of Renastart in infants

2 DISCLAIMER: The guidelines contained in this document are for use of Renastart in children less than 1 year old. These guidelines are for use by Health Professionals working in Paediatric Nephrology These guidelines are not for use by parents of children with kidney disease. These guidelines are for general information only and must not be used as a substitute for professional medical advice or treatment. The product information contained in these guidelines although accurate at the time of publication is subject to change. The most current information may be obtained by referring to product labels. Author: Marion Martin BSc (Hons) RD Senior Paediatric Dietitian United Kingdom

3 This guideline should be read in conjunction with KDOQI Clinical Practice Guideline for Nutrition in Children with CKD: 2008 Update, (KDOQI Work Group 2009). This guideline is based on best practice within the UK of using low potassium feeds such as Renastart in infants to control blood potassium levels in kidney disease. Potassium lowering medications are not routinely used, being reserved for emergency situations. What is Renastart? Renastart is a high energy powdered formula with low levels of potassium, protein, calcium, chloride, phosphorus and vitamin A. Renastart contains protein, carbohydrate, fat, vitamins, minerals, trace elements and the long-chain polyunsaturated fatty acids (LCP s) Arachidonic acid (AA) and Docosahexaenoic acid (DHA). Use of Renastart Renastart is used for the dietary management of hyperkalaemia in kidney disease in infants. Renastart can be used in Chronic Kidney Disease (CKD) and Acute Kidney Injury (AKI). Treatment of kidney disease in infants is multifaceted therefore the use of Renastart should be carried out in conjunction with appropriate members of the Paediatric Renal Team e.g. Renal Dietitian, Nephrologist and Dialysis Nurse. Modification of feed is typically the first line management of hyperkalaemia in infants with kidney disease. Other treatments may be used in conjunction with feed modification including medications, fluid prescriptions and dialysis. Indication for the use of Renastart The KDOQI Work Group (2009) states that Potassium intake should be limited for children with CKD stages 2 to 5 and 5D who have or are at risk of hyperkalemia. Renastart is designed to be used when hyperkalaemia is present. Hyperkalaemia is defined as a plasma potassium level above the normal reference range. The typical UK plasma potassium (K) reference ranges are as follows: Age < 1 month : mmol/l Age > 1 month : mmol/l However local biochemistry reference ranges should be used in conjunction with this guideline for the use of Renastart. Additionally due consideration must be given to other potential causes of hyperkalaemia before commencing Renastart such as a haemolysed blood sample, acidosis, catabolism and medications that can affect plasma potassium levels e.g. potassium sparing diuretics and ACE inhibitors. These aspects should be addressed appropriately before commencing Renastart. 1

4 Rationale for the use of Renastart Renastart is used to lower dietary potassium intake to the amount that is required to maintain plasma levels within the normal reference range. Renastart can be taken orally or as a tube feed. Renastart contains a much lower level of potassium than mature breast milk and standard infant formulas as shown in the following table. Goals of nutrition support with Renastart The primary goal of nutrition support with Renastart is to maintain plasma potassium levels within the normal reference range. It is vital to ensure that plasma potassium levels do not drop too low as well as avoidance of high levels. This will require close monitoring of plasma potassium levels, potassium intake and adjustments to feed as appropriate. Table 1: Potassium content of mature breast milk, standard infant formula and Renastart. Potassium (mmol) per 100ml Mature breast milk 1 Average 1.5 Standard infant formula Average 1.6 (whey based) 2 Renastart 20% dilution 0.6 (100kcal/100ml) 3 Renastart 13.5% dilution 0.4 (67kcal/100ml) 3 1 Source: Food Standards Agency (2002) McCance and Widdowson s The Composition of Foods, Sixth summary edition. Cambridge: Royal Society of Chemistry. 2 Source: Average of 3 infant formulas widely available in the UK, calculated from manufacturers data. 3 20% dilution: 20g Renastart made up to 100ml with water. 13.5% dilution: 13.5g Renastart made up to 100ml with water. For comparison of protein, energy, sodium, potassium, phosphorus, calcium and vitamin A in breast milk, standard infant formula and Renastart see Table 2 on page 3. In the majority of applications Renastart will need to be used in conjunction with standard infant formula or breast milk to achieve the potassium intake required to maintain plasma potassium levels within the normal reference range. Renastart may be used alone initially to decrease a very high plasma potassium level to within the normal reference range. One of the major goals in the treatment of infants and children with CKD is to achieve normal growth and development (Kalantar-Zadeh et al; 2011). It is important to regularly assess nutritional intake and requirements of the child to ensure individual needs are met based on growth, development and stage of kidney disease. Renastart has the following additional nutritional features that are beneficial in chronic kidney disease in infants: A lower level of phosphorus than standard infant formulas: If plasma phosphate is elevated in CKD, phosphorus intake should be limited to the recommended levels (Klaus et al; 2006). Avoidance of hyperphosphataemia helps to minimise the risk of renal osteodystrophy and development of cardiovascular disease in paediatric renal patients. A lower level of calcium than standard infant formulas: The KDOQI Work Group (2009) suggests that the total oral and/or enteral calcium intake from nutritional sources and phosphate binders be in the range of 100% to 200% of the DRI for calcium for age. The lower level of calcium in Renastart allows the use of calcium containing phosphate binders and minimises the likelihood of exceeding this recommendation. 2

5 A higher level of sodium than standard infant formulas: Sodium requirements vary according to type of renal disease in children (Rees & Shaw, 2007). Several of the most common causes of CKD in infancy are associated with sodium wasting. Growth in children with chronic renal failure caused by polyuric, salt wasting diseases may be hampered if ongoing sodium and water losses are not corrected (Parekh et al; 2001). In infants who do not require higher sodium intake the use of Renastart may be contraindicated. A lower level of vitamin A than standard infant formulas: The KDOQI Work Group (2009) recommends that total intake of vitamin A should be limited to DRI for age. Energy and protein: The powder presentation allows flexibility with dilutions to facilitate the provision of adequate energy and protein to support growth in infants with CKD. Renastart can be mixed with other formulas and supplements to meet the varying nutritional requirements and fluid prescriptions found in infants at the various stages of CKD. Table 2: Comparison of Renastart, breast milk and infant formula The following table compares the levels of protein, energy, sodium, potassium, phosphorus, calcium and low Vitamin A in Renastart with breast milk and standard infant formula. Per Protein Energy Na K P Ca Vit A 100 ml g kcal mg/mmol mg/mmol mg mg IU/µg Renastart 20% dilution / / / 25.6 Renastart 15% dilution / / / 19.2 Renastart 13.5% dilution 1, / / / 17.3 Mature breast milk / / / 58 Infant formula Standard dilution / / / 58 1 It is not recommended that Renastart is fed at this dilution unless the volume taken is adequate to ensure protein intake meets KDOQI (2009) requirements. 2 Source: Average of 3 infant formulas widely available in the UK, calculated from manufacturers data. 3 Source: Food Standards Agency (2002) McCance and Widdowson s The Composition of Foods, Sixth summary edition. Cambridge: Royal Society of Chemistry. 4 20% dilution: 20g Renastart made up to 100ml with water. 15% dilution: 15g Renastart made up to 100ml with water. 13.5% dilution: 13.5g Renastart made up to 100ml with water. 3

6 Illustrative recipes Renastart is often used in conjunction with standard infant formulas or breast milk. The following tables illustrate the content of key nutrients in 100ml feed containing differing proportions and concentrations of Renastart combined with standard infant formula. Tables 3 and 4 illustrate recipes containing 20% Renastart and 15% Renastart respectively. These recipes are for illustration only and show how the substitution of Renastart into the infant feed can alter the intake of potassium, phosphorus, calcium, sodium, protein and energy. When using Renastart the requirements of the infant should be individually assessed and intakes of the key nutrients calculated using manufacturer s data for the actual infant formula used or for breast milk. Table 3: Key nutrient analysis in 20% Renastart mixed with standard infant formula where R20% comprises 20g Renastart made up to 100ml with water and IF is standard infant formula. All analyses per 100ml. R20% IF Protein Energy Na K P Ca ml ml g kcal mg/mmol mg/mmol mg mg / / / / / / / / / / Table 4: Key nutrient analysis in 15% Renastart mixed with standard infant formula where R15% comprises 15g Renastart made up to 100ml with water and IF is standard infant formula. All analysis per 100ml. R15% IF Protein Energy Na K P Ca ml ml g kcal mg/mmol mg/mmol mg mg / / / / / / / / / /

7 Establishing the child on Renastart 1. The decision to commence feeding with Renastart and the initial proportion of Renastart in the total feed should be made on an individual patient basis by the physician and/or dietitian. Consideration should be given to the diagnosis, previous intake of potassium, plasma potassium level and rate of increase of plasma potassium. The following 2 examples may help to illustrate this: Example A: A 2 month old infant diagnosed with CKD at birth. The creatinine level has been rising steadily but at todays clinic the creatinine and potassium have risen sharply with potassium level at 6.6mmol/l. The infant has been fed on either breast milk or standard infant formula from birth. In this case it would be appropriate to consider a change to an exclusively Renastart feed to minimise the potassium intake until the plasma potassium decreases to a level within the normal reference range. The basis for this recommendation is that the potassium level had increased rapidly to a value above the normal reference range and it is important to minimise the potassium intake to prevent a further increase and ensure the plasma potassium level is restored to the normal reference range. Example B: A 5 month old child diagnosed with CKD at birth. Creatinine has been slowly increasing since birth with a steady but sustained rise in potassium to a level of 5.2mmol/l at clinic today. i.e. just above normal reference range. This child had been fed on either breast milk or infant formula from birth. In this case it may be more appropriate to consider starting with a feed comprising half Renastart and half standard infant formula or breast milk rather than exclusively Renastart. The basis for this recommendation is that the plasma potassium level had slowly increased and is only just above the normal reference range. Renastart alone may lead to a decrease in plasma potassium to a level below the normal reference range. In both examples the plasma potassium level should be rechecked approximately 24 hours following commencement of new feed recipe and potassium content of feed changed as appropriate. 5

8 2. The dilution of Renastart and volume of feed to be given should be determined by the physician and/or dietitian. Children with renal failure often have reduced appetites potentially resulting in inadequate nutritional intakes. Poor appetite in CKD can be caused by a combination of factors including reduced taste sensation (Armstrong et al; 2010), the requirement for multiple medications and the preference for water over milk in the polyuric child (Rees & Mak, 2011). Vomiting is common and may result from gastro-oesophageal reflux and delayed gastric emptying. Fluid intakes may be restricted and depending on the level of restriction this can make the achievement of nutritional aims more difficult. Renastart is typically used in infants at dilutions providing between 75 kcal per 100ml and 100kcal per 100ml. Where feed volume intake is restricted a higher concentration of Renastart e.g. providing 100kcal/100ml, may be appropriate to ensure nutritional requirements are met. At lower concentrations protein intake should be closely monitored and adjusted as necessary to ensure KDOQI Work Group (2009) guidelines and individual needs are being met. This will depend on volume of feed taken. See Table 2 on page 3 for comparison of dilutions. 3. When establishing infants on Renastart feeds it is essential to check plasma potassium levels regularly to ensure that the level of potassium in the feed is lowering plasma levels to within the normal reference ranges whilst not allowing plasma levels to fall below the normal reference range. For this reason it is recommended that plasma potassium is checked daily until levels are stable and within the normal reference range. foods potassium intake can be increased by allowing more potassium in foods taken orally. 5. When the physician / dietitian is satisfied that the plasma potassium level is stable and within the normal reference range it is recommended that they determine the frequency of review of the blood biochemistry, feed composition, intake and growth. 6. It is recommended that the nutritional status and particularly the intakes of energy, protein, sodium, phosphorus and calcium should be monitored whilst taking Renastart as the content of these nutrients in Renastart differs from the content found in standard infant formulas. Energy and protein intakes should meet KDOQI Work Group (2009) guidelines and individual patient needs as determined by clinical evaluation. The concentration of Renastart can be adjusted to ensure that protein and energy requirements are met in conjunction with varying fluid intakes or restrictions. If the infant is on dialysis it may be necessary to add extra protein e.g. Vitapro (Vitaflo International Ltd.) to the feed to ensure that protein needs are met. If sodium supplements are being given the dose should be reviewed as Renastart has a higher sodium content than standard infant formulas. If phosphate binders are being given the dose should be reviewed as Renastart has a lower phosphorus content than standard infant formulas. Calcium intake from feed and medications should be assessed as Renastart has a lower calcium content than standard infant formulas to ensure KDOQI Work Group (2009) recommendations are being met. 4. Once the plasma potassium level has decreased to within the normal reference range the potassium level of the feed may need to be increased to prevent the plasma level dropping too low. This is achieved by increasing the proportion of standard infant formula or breast milk in the feed recipe. Alternatively if the child is established on weaning 6

9 Example case study Objective To illustrate use of Renastart in an infant with CKD and comparison of intakes to KDOQI Work Group [2009] recommendations. History (Day 1) A 3 month old girl, diagnosed in the neonatal period with CKD, has now reached stage 4 CKD (KDOQI Work Group 2009). She currently weighs 5kg (9th Centile) (UK-WHO growth charts 2009). However, her weight gain has slowed over the last 2 weeks in line with decreasing feed intake and small vomits 1-2 times per day. She takes all her feed orally. However, her intake has decreased from approximately 750ml (150ml/kg) standard infant formula daily to approximately 600ml (120ml/kg) daily over the same period. As part of her clinical management she receives sodium supplements to manage salt wasting and calcium carbonate based phosphate binders. Today she presented with a plasma potassium of 6.5mmol/l whereas the normal reference range is mmol/l. Her most recent potassium levels, prior to today, have been towards the top end of the normal reference range. Dietetic management (Day 1) Action Prior to making any change to the feed regimen the dietitian gave due consideration to, and eliminated, other potential causes of hyperkalaemia such as a haemolysed blood sample, acidosis, catabolism and medications that may have affected plasma potassium levels. Rationale It is important to eliminate alternative causes for elevated plasma potassium levels to ensure that Renastart is the appropriate management approach. At today s clinic she presented with a very high plasma potassium level. It is important to minimise potassium intake to bring the plasma potassium level within the reference range. Therefore the standard infant formula was stopped and the whole feed replaced with 20% Renastart. 600ml daily minimum was advised as this was the volume the child was voluntarily taking when she presented at today s clinic. 20% Renastart was advised as this concentration ensures that the child s protein and energy requirements as recommended by KDOQI Work Group (2009) could be met within the 600ml volume. Energy requirement was based on UK Estimated Average Requirement (EAR) for energy (Department of Health, 1991). Monitoring of the plasma potassium level 24 hours following the change in feed regimen was advised to assess the response of the plasma potassium to the reduced potassium feed. It is important to check that the high plasma potassium level was decreasing but equally important to check that the level had not dropped too low as low plasma potassium levels can also have serious consequences. The following table compares intakes of protein, energy, sodium, potassium, phosphorus and calcium from the two feeds and compares intakes with the KDOQI Work Group (2009) guideline. The dietitian advised feeding a minimum of 600ml (120ml/kg) of 20% Renastart (120g Renastart powder made up to 600ml with water) daily. After 24 hours on the new feed regimen the plasma potassium level was checked. 7

10 Table 5: Comparison of nutritional intakes from 20% Renastart and standard infant formula with the KDOQI [2009] guideline. 600ml 20% Renastart 600ml standard infant Nutritional aim per day provides per day formula provides per day Taken from KDOQI [2009] Protein 9.0g 1.8g/kg 1 7.8g 1.6g/kg g/kg 1 Energy 594kcal 2 119kcal/kg 396kcal 79kcal/kg Estimated Average Requirement for energy (EAR), 515kcal 7 Sodium (Na) 12.6mmol 3 2.5mmol/kg 4.2mmol 0.8mmol/kg Dependant on blood biochemistry levels Potassium (K) 3.6mmol 4 0.7mmol/kg 9.6mmol 1.9mmol/kg Dependant on blood biochemistry levels Phosphorus (P) 110mg 5 22mg/kg 150mg 30mg/kg Less than 100mg Calcium (Ca) 136mg 6 27mg/kg 270mg 54mg/kg mg from diet and Ca containing phosphate binders. Notes 1 Recommended protein requirement is met. 2 Energy provided exceeds EAR. This enables catch up in weight gain. 3 Increased sodium provision from feed, therefore a review of sodium supplements is required. 4 Potassium provision from feed reduced from 1.9mmol/kg to 0.7mmol/kg. 5 Phosphorus provision minimised to give a close approach to the KDOQI 2009 guideline. The lower phosphorus intake may offer the opportunity to reduce the use of phosphate binders in response to lower blood phoshate levels. 6 Decreased calcium provision from feed, therefore a review of total calcium intake from diet and calcium based phosphate binders is required. Use of Renastart may offer the opportunity to increase the use of calcium based binders without inducing hypercalcaemia. 7 Department of Health. Report on Health and Social Subjects No 41 (1991) Dietary reference values for food energy and nutrients for the United Kingdom. 8

11 Dietetic follow up (Day 3) Patient monitoring The child took the 600 ml of feed offered orally with one small vomit. She seemed settled between feeds. 24 hours following the introduction of Renastart the blood biochemistry showed that the plasma potassium level had decreased to 3.9mmol/l, which was towards the lower end of the normal reference range of mmol/l. Action The dietitian advised an increase in feed potassium by adding standard infant formula back into the feed recipe at the rate of 1 part standard infant formula to 3 parts 20% Renastart e.g. 25ml standard infant formula plus 75ml of 20% Renastart in each 100ml feed. The dietitian also advised continuing to offer a minimum of 600ml of feed daily (120ml/kg/day). After 24 hours on the revised feed regimen, recheck the plasma potassium level and measure weight. Rationale The patient s blood biochemistry showed that her plasma potassium level had decreased significantly and was now near the lower end of the normal reference range. If the plasma potassium level continued to decline at the same rate it is likely to fall below the normal reference range with potentially serious consequences. To halt the decline a proportion of standard infant formula is reintroduced into the feed recipe. The child took the 600 ml feed regimen with no increase in vomiting. She also appeared settled between feeds, therefore no change to daily feed volume. The advised feed recipe continues to provide an energy intake in excess of the Estimated Average Requirement (EAR) for energy therefore potentially enabling catch up in weight gain. Monitoring of the plasma potassium level 24 hours following the change in feed regimen was advised to assess the response of the plasma potassium to the increased potassium feed. It is important to check that the plasma potassium level does not fall below the normal reference range. Equally it remains important to check that the plasma potassium level does not rise again above the normal reference range following the increased potassium content of the feed. The following table compares intakes of protein, energy, sodium, potassium, phosphorus and calcium from the two feeds and compares intakes with the KDOQI Work Group (2009) guideline. 9

12 Table 6: Comparison of nutritional intakes from 150ml standard infant formula mixed with 450ml 20% Renastart and 600ml of 20% Renastart with the KDOQI [2009] guideline. 150ml standard infant formula 600ml 20% Renastart Nutritional aim per day with 450ml 20% Renastart provides per day Taken from KDOQI [2009] provides per day Protein 9.0g 1.8g/kg 1 9.0g 1.8g/kg g/kg 1 Energy 546kcal 2 109kcal/kg 594kcal 119kcal/kg Estimated average Requirement for energy (EAR), 515 kcal 7 Sodium (Na) 10.2mmol 3 2.0mmol/kg 12.6mmol 2.5mmol/kg Dependant on blood biochemistry levels Potassium (K) 5.4mmol 1.1mmol/kg 4 3.6mmol 0.7mmol/kg 4 Dependant on blood biochemistry levels Phosphorus (P) 120mg 5 24mg/kg 110mg 22mg/kg Less than 100 mg Calcium (Ca) 174mg 6 35mg/kg 136mg 27mg/kg mg from diet and Ca containing phosphate binders. Notes 1 Recommended protein requirement is met. 2 Energy provided exceeds EAR. This enables catch up in weight gain. 3 Slightly decreased sodium provision from feed, therefore a review of sodium supplements is required. 4 Increased potassium provision from 0.7 mmol/kg to 1.1 mmol/kg. 5 Slightly increased phosphorus provision due to inclusion of a proportion of infant formula in the feed recipe. However, the provision remains lower than a feed consisting of standard infant formula alone. The use of phosphate binders should be reviewed in response to blood phoshate levels. 6 Slightly increased calcium provision from feed, therefore a review of total calcium intake from diet and calcium based phosphate binders is required. Use of Renastart may offer the opportunity to increase the use of calcium based binders without inducing hypercalcaemia. 7 Department of Health. Report on Health and Social Subjects No 41 (1991) Dietary reference values for food energy and nutrients for the United Kingdom. 10

13 Dietetic follow up (Day 3) Patient monitoring The child continued to take the 600 ml of feed offered orally with one small vomit. She seemed settled between feeds. 24 hours following the re-introduction of standard infant formula to the feed recipe the blood biochemistry showed that the plasma potassium level had risen to 4.1mmol/l, comfortably in the normal reference range of mmol/l. When she was weighed she was found to have gained 70g over the last 2 days. Action Dietitian advised continuing with present feed regimen. Clinician/Dietitian advised review of blood biochemistry, feed intake and tolerance and weight in 3 days. Rationale Ongoing dietetic follow up At each review the nutritional intake, growth, blood biochemistry and relevant medications should be reviewed e.g. sodium supplements and phosphate binders. The potassium content of the feed recipe should be titrated against the plasma potassium level to achieve a stable plasma potassium level within the normal reference range. With each change of recipe e.g. as the child grows or in response to decreasing renal function the intakes of sodium, phosphorus and calcium from all sources including supplements and binders should be reviewed. As the child grows the protein and energy intakes should be revised to maintain appropriate growth and ensure the KDOQI (2009) guideline is met. The patients plasma potassium level has risen slightly and is within the normal range. However, it is too early to conclude that it has stabilised. She has gained weight at an acceptable rate in the last two days. However, it is also too early to conclude that a normal growth rate has been achieved. 11

14 References Armstrong, J.E; Laing, D.G; Wilkes, F.J. & Kainer, G. (2010) Smell and taste function in children with chronic kidney disease. Pediatr Nephrol. 25, Department of Health. (1991) Dietary Reference Values for Food, Energy and Nutrients for the United Kingdom. London: HMSO, Report on Health and Social Subjects No 41. Kalantar-Zadeh, K; Cano, N.J; Budde, K; Chazot, C; Kovesdy, C.P; Mak, R.H; Mehrotra, R; Raj, D.S; Sehgal, A.R; Steinvinkel, P. & Ikizler, T.A. (2011) Diets and enteral supplements for improving outcomes in chronic kidney disease. Nat. Rev. Nephrol. 7, KDOQI Work Group. (2009) KDOQI Clinical Practice Guideline for Nutrition in Children with CKD: 2008 Update. Am J of Kidney Dis. 53, S1-S124 (suppl 2). Klaus, G; Watson, A; Edefonti, A; Fischbach, M; Rönnholm, K; Schaefer, F; Simkova, E; Stefanidis, C.J; Strazdins, V; Vande Walle, J; Schröder, C; Zurowska, A. & Ekim, M. (2006) Prevention and treatment of renal osteodystrophy in children on chronic renal failure: European guidelines. Pediatr Nephrol 21(2), Parekh, R.S; Flynn, J.T; Smoyer, W.E; Milne, J.L; Kershaw, D.B; Bunchman, T.E. & Sedman, A.B. (2001) Improved Growth in Young Children with Severe Chronic Renal Insufficiency Who Use Specified Nutritional Therapy. J Am Soc Nephrol. 12, Rees, L. & Mak, R.H. (2011) Nutrition and growth in children with chronic kidney disease. Nat. Rev.Nephrol. 7, Rees, L. & Shaw, V. (2007) Nutrition in children with CRF and on dialysis. Pediatr Nephrol. 22 (10), UK-WHO growth charts Royal College of Paediatrics and child health. 12

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