Guideline for the use of Renastart in children over one year old

Transcription

1 Guideline for the use of Renastart in children over one year old

2 DISCLAIMER: The guidelines contained in this document are for use of Renastart in children over 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 children 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 children up to 10 years of age. Renastart can be used in Chronic Kidney Disease (CKD) and Acute Kidney Injury (AKI). Treatment of kidney disease in children 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 and/or foods is typically the first line management of hyperkalaemia in children 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 standard paediatric enteral feeds and cow s milk as shown in the following table. Table 1: Comparison of standard paediatric enteral feed, cows milk and Renastart. Potassium content per 100ml Standard Paediatric Enteral feed (1kcal/ml) 1 Full fat cows milk 2 Renastart 20% dilution (1kcal/ml) 3 Renastart 40% dilution (2kcal/ml) 3 Potassium (mmol) per 100ml 2.8mmol 3.9mmol 0.6mmol 1.2mmol 1 Source: Average of 2 standard paediatric enteral feeds (1kcal/ml) widely available in the UK, calculated from manufacturers data. 2 Source: Food Standards Agency (2002) McCance and Widdowson s The Composition of Foods, Sixth summary edition. Cambridge: Royal Society of Chemistry. 3 Renastart 20% Dilution: 20g Renastart made up to 100ml with water. Renastart 40% Dilution: 40g Renastart made up to 100ml with water. For comparison of protein, energy, sodium, potassium, phosphorus, calcium and vitamin A in standard paediatric enteral feeds, cows milk and Renastart see Table 2 on page 3. In the majority of applications where the child is totally fed via a nasogastric tube or gastrostomy tube Renastart will be used in conjunction with standard paediatric enteral feeds 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. Renastart can also be used as a low potassium nutritional supplement to oral diet. 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 both plasma potassium levels and potassium intake and adjustments to feed as appropriate. 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 children: A lower level of phosphorus than standard paediatric enteral feeds and cows milk: 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 paediatric enteral feeds and cows milk: 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 lower level of vitamin A than standard paediatric enteral feeds: The KDOQI Work Group (2009) recommends that total intake of vitamin A should be limited to DRI for age. Many paediatric enteral feeds contain higher levels of vitamin A thereby making it more difficult to achieve this recommendation. A lower level of sodium than standard paediatric enteral feeds: The sodium level of Renastart at 20% dilution (1kcal/ml) is slightly lower than standard paediatric enteral feeds (1kcal/ml). Sodium requirements vary according to type of renal disease in children (Rees & Shaw, 2007). The level of sodium in Renastart allows it to be taken if a lower level of sodium is required e.g. if the child is hypertensive. However, if the child has a salt wasting condition then sodium supplements will need to be considered. 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). Energy and protein: The powder presentation allows flexibility with dilutions to facilitate the provision of adequate energy and protein to support growth in children with CKD. Renastart can be concentrated to provide an energy content of up to 2kcal/ml. It can be mixed with other formulas and supplements to meet the varying nutritional requirements and fluid prescriptions found in children at the various stages of CKD. Renastart can be taken unflavoured or can be flavoured to make a palatable oral supplement. Table 2: Comparison of Renastart, standard paediatric enteral feed and cows milk The following table compares the levels of protein, energy, sodium, potassium, phosphorus, calcium and low Vitamin A in Renastart, standard paediatric enteral feeds and cows milk. Per Protein Energy Na K P Ca Vit A 100ml g kcal mg/mmol mg/mmol mg mg IU/µg Renastart 20% Dilution / / / 25.6 Renastart 30% Dilution / / / 38.4 Renastart 40% Dilution / / / 51.2 Standard paediatric enteral feed / / / 43 Whole cows milk / / / 30 1 Renastart 20% Dilution: 20g Renastart made up to 100ml with water. Renastart 30% Dilution: 30g Renastart made up to 100ml with water. Renastart 40% Dilution: 40g Renastart made up to 100ml with water. 2 Source: Average of 2 standard paediatric enteral feeds (1kcal/ml) 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. 3

6 Illustrative recipes Renastart is often used in conjunction with standard paediatric enteral feeds. The following tables illustrate the content of key nutrients in 100ml feed containing differing proportions and concentrations of Renastart combined with a standard paediatric enteral feed (1kcal/ml). These recipes are for illustration only and show how the substitution of Renastart into the child s feed can alter the intake of potassium, phosphorus, calcium, sodium, protein and energy. When using Renastart the child s requirements should be individually assessed and intakes of key nutrients calculated using manufacturer s data for the actual enteral feed used. Table 3: Key nutrient analysis in 20% Renastart mixed with standard paediatric enteral feed where R20% comprises 20g Renastart made up to 100ml with water and SPEF is standard paediatric enteral feed. All analysis per 100ml. R20% SPEF Protein Energy Na K P Ca ml ml g kcal mg/mmol mg/mmol mg mg / / / / / / / / / / Table 4: Key nutrients analyses in 30% Renastart mixed with standard paediatric enteral feed where R30% comprises 30g Renastart made up to 100ml with water and SPEF is standard paediatric enteral feed. All analyses per 100ml. R30% SPEF 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 Renastart and the initial proportion of Renastart in the total feed, or in addition to oral diet 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, if tube fed or feeding orally, plasma potassium level and rate of increase of plasma potassium. The following 2 examples may help to illustrate this: Example A: A 2 year old child diagnosed with CKD at 1 year of age. The creatinine level has been rising steadily but at today s clinic the creatinine and potassium have risen sharply with potassium level at 6.6mmol/l. The child is on a gastrostomy feed of standard paediatric enteral feed providing 50% of energy requirement and eats small amounts of low potassium foods. 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. The plasma potassium level should be rechecked approximately 24 hours following commencement of new feed recipe and potassium content of feed changed as appropriate. Example B: A 3 year old child diagnosed with CKD at 2 years of age. Creatinine has been slowly increasing over the last year with a steady but sustained rise in potassium to a level of 5.3mmol/l at clinic today. i.e. just above normal reference range. This child has a supplementary tube feed of standard paediatric enteral feed providing 50% of energy requirement. He takes small amounts of low potassium foods throughout the day. In this case it is more appropriate to consider starting with a feed comprising half Renastart and half standard paediatric enteral feed initially 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. The plasma potassium level should be rechecked 4-5 days following commencement of new feed recipe and potassium content of feed changed as appropriate. 2. The dilution of Renastart and volume of feed to be given should be determined by the physician and/or dietitian. This will be based on nutritional requirements, fluid allowance and nutritional contribution of other foods/feeds. 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 children at dilutions providing between 1kcal/ml (20g made up to 100ml with water) and 2kcal/ml (40g made up to 100ml with water). Where feed volume intake is restricted a higher concentration of Renastart e.g. providing 2kcal/ml may be appropriate to ensure nutritional requirements are met. 5

8 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 children 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 or at intervals agreed between physician and dietitian until levels are stable and within the normal reference range. 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 paediatric enteral feed in the feed recipe. Alternatively if the child is eating, 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 nutritional status and particularly the intakes of energy, protein, sodium, phosphorus and calcium should also be monitored whilst taking Renastart as the content of these nutrients in Renastart differs from the content found in standard paediatric enteral feeds. 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 child 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 slightly lower sodium content than standard paediatric enteral feeds. If phosphate binders are being given the dose should be reviewed as Renastart has a lower phosphorus content than standard paediatric enteral feeds. Calcium intake from feed, food and medications should be assessed as Renastart has a lower calcium content than standard paediatric enteral feeds to ensure KDOQI Work Group (2009) recommendations are being met. 6

9 Example case study Objective To illustrate use of Renastart in a child with CKD and comparison of intakes to KDOQI (2009) recommendations. History Tom, a 2 year old boy, diagnosed with CKD at 1 year old has now reached stage 4 CKD (KDOQI Work Group 2009). He currently weighs 10.5kg (9th Centile) (UK- WHO growth charts 2009). His appetite has decreased over the past year and he receives approximately 50% of his nutritional requirement from a standard paediatric enteral feed via a gastrostomy tube. He eats small amounts of food and has energy supplements added to foods and drinks. Mum has been advised on providing a low potassium diet for Tom. As part of his clinical management he receives calcium carbonate based phosphate binders. Today Tom presented with a plasma potassium of 5.7mmol/l whereas the normal reference range is mmol/l. His most recent potassium levels have been towards the top end of the normal reference range. Creatinine, urea and phosphate levels have all increased today. His weight had been static over the last month. His food intake has lessened since commencing the low potassium diet and mum has not been using the energy supplements. He is tolerating his feed. Clinical and 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. The clinician discussed with mum that dialysis would need to be considered over the next few weeks. The dietitian advised that the gastrostomy feed should be changed to a Renastart feed and advised mum to continue with 500ml volume daily but increase energy density of feed from 1kcal/ml to 1.5kcal/ml. This was achieved by making the Renastart as 150g Renastart powder made up to 500ml with water. Mum was advised to continue encouraging foods, to continue with low potassium diet and to stop offering energy supplements. She was also advised to not alter the dose of calcium containing phosphate binders. After 24 hours on the new feed regimen the plasma potassium level was checked. 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 Tom presented with biochemistry indicating decreasing renal function therefore a plan for commencement of dialysis had to be discussed. At today s clinic he presented with a high plasma potassium level. It is important to minimise potassium intake to bring the plasma potassium level within the reference range. Therefore the standard paediatric enteral feed was stopped and the whole feed replaced with Renastart at 1.5kcal/ml, (150g Renastart made up to 500ml with water) to reduce potassium intake. 7

10 Mum was advised to continue with 500ml feed daily as Tom was tolerating this volume of feed. Renastart at 1.5kcal/ml was advised as this concentration provides 750kcal in 500ml compared with 500kcal in the previous feed. Increased energy intake from the feed was desirable as Tom s food intake had decreased, he was not taking the energy supplements and his weight had been static over the previous month. KDOQI Work Group (2009) recommends 100% EER for age. For Tom this would be the UK Estimated Average Requirement (EAR) for energy (Department of Health, 1991). As well as reducing potassium intake the use of Renastart will also reduce protein and phosphorus intake which is beneficial as both plasma urea and phosphate levels had increased. 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 previous feed (standard paediatric enteral feed) to the new feed (1.5kcal/ml Renastart) and shows the nutritional aim from the KDOQI Work Group (2009) guideline. A small amount of food is being taken in addition to feed so intake from the feed is not going to fully meet protein and energy requirements but the comparisons illustrate how Renastart can help to bring nutritional intakes in line with the KDOQI Work Group (2009) guideline. Table 5: Comparison of nutritional intakes from Renastart 1.5kcal/ml and standard paediatric enteral feed with the KDOQI [2009] guideline 500ml Renastart 500ml standard Nutritional aim 1.5kcal/ml paediatric enteral feed per day provides per day provides per day Taken from KDOQI [2009] Protein 11.5g 1 1.1g/kg 14.0g 1.3g/kg g/kg Energy 740kcal 2 71kcal/kg 500kcal 48kcal/kg Estimated Average Requirements for Energy (EAR) 1230kcal 7 Sodium (Na) 15.5mmol 3 1.5mmol/kg 13mmol 1.2mmol/kg Dependant on blood biochemistry levels Potassium (K) 4.5mmol 4 0.4mmol/kg 14mmol 1.3mmol/kg Dependant on blood biochemistry levels Phosphorus (P) 138mg 5 13mg/kg 260mg 25mg/kg Less than 370mg Calcium (Ca) 170mg 6 16mg/kg 290mg 28mg/kg 500mg from diet and Ca containing phosphate binders. 1 Reduced protein provision from feed. 2 Increased energy provision from same volume (500ml) of feed. 3 Increased sodium provision from feed. 4 Reduced potassium provision from feed. 5 Reduced phosphorus provision from feed. 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 phosphate 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 2) Patient monitoring Tom tolerated the 500ml Renastart feed and continued to eat small amounts of low potassium diet. 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 discussed with mum that the potassium level had decreased and that a small amount of potassium should be reintroduced into the diet as food or added to the feed by introducing a small volume of standard paediatric enteral feed into the feed recipe. Mum chose to reintroduce a small amount of higher potassium food each day as she felt this may encourage Tom to eat more. He continued to have 500ml Renastart daily via the gastrostomy. After 48 hours on the revised regimen, recheck the plasma potassium level and measure weight. Rationale Tom s blood biochemistry showed that his 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 an increase in potassium intake was advised. Tom tolerated the 500 ml feed regimen therefore no change to daily feed volume. Monitoring of the plasma potassium level 48 hours following the change in potassium intake was advised to assess the response of the plasma potassium to the increased potassium in the diet. 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 diet. Weight was rechecked to ensure that Tom is not losing weight. Dietetic follow up (Day 4) Patient monitoring Tom continued to take the 500ml of feed daily via his gastrostomy. 48 hours following the re-introduction of a small amount of higher potassium containing food daily blood biochemistry showed that the plasma potassium level had risen to 4.1mmol/l, comfortably in the normal reference range of mmol/l. Urea and phosphate levels had decreased by small amounts relative to day 1. When Tom was weighed he had gained 60g since his initial clinic visit. Action The dietitian advised mum to continue with present feed and diet regimen and to contact the dietitian if oral intake changed. Continue with present dose of phosphate binders. The physician and dietitian advised review of blood biochemistry, feed and food intake, weight and medication including phosphate binders in 1 week. 9

12 Rationale The patient s plasma potassium level has risen slightly and is within the normal range. However, it is too early to conclude that it has stabilised hence review in 1 week. Tom had gained a small amount of weight. However, it is also too early to conclude that his nutritional intake is adequate to support satisfactory weight gain. Although blood phosphate level had decreased slightly, more time is required to assess the response to lowered phosphorus intake before the phosphate binder dose is reviewed. Ongoing dietetic follow up At each review the nutritional intake, growth, blood biochemistry and relevant medications should be reviewed e.g. phosphate binders. The potassium content of the feed and diet should be titrated against the plasma potassium level to achieve a stable plasma potassium level within the normal reference range. With each change of feed 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. 10

13 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. 11

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