THE CHOICE OF DIALYSIS SOLUTIONS IN PEDIATRIC CHRONIC PERITONEAL DIALYSIS: GUIDELINES BY AN

AD HOC EUROPEAN COMMITTEE1

Cornelis H. Schröder

On behalf of the European Pediatric Peritoneal Dialysis Working Group*

Correspondence:

C.H. Schröder, MD, PhDDept. of Pediatric NephrologyWilhelmina Children University HospitalPOB 850903508 AB UtrechtThe NetherlandsTel.: +31.30.2504001Fax: +31.30.2505349E-mail: c.h.schroder@wkz.azu.nl

c.hschroder@freeler.nl

*The European Pediatric Peritoneal Dialysis Working Group: A. Edefonti, I Clinici di Perfezionamento, Milan, ItalyM. Fischbach, Hôpital de Hautepierre, Strasbourg, FranceG. Klaus, University of Marburg, Marburg, GermanyK. Rönnholm, University of Helsinki, Helsinki, FinlandF. Schaefer, University of Heidelberg, Heidelberg, GermanyE. Simkova, University Hospital Motol, Prague, Czech Republic D. Stefanidis, A&P Kyriakou Childrens Hospital, Athens, GreeceV. Strazdins, University of Riga, Riga, LatviaJ. Vande Walle, University of Ghent, Ghent, BelgiumA. Watson, Nottingham City Hospital, Nottingham, United KingdomA. Zurowska, University of Gdansk, Gdansk, Poland

1 Published in Perit Dial Int 2001;21:568-574

1

Abstract

Objective: To provide guidelines on the choice of dialysis solutions in children on chronic

peritoneal dialysis.

Setting: European Pediatric Peritoneal Dialysis Working Group (EPPWG)

Data source: Literature on the application of peritoneal dialysis solutions in children

(evidence) and discussions within the group (opinion).

Conclusions: Glucose is the standard osmotic agent for peritoneal dialysis in children

(evidence). The lowest glucose concentration needed should be used (opinion). Low calcium

solution (1.25 mmol/L) should be applied, wherever possible, with careful monitoring of

parathyroid hormone levels (opinion). The use of amino acids containing dialysis fluids can

be considered in malnourished children, although aggressive enteral nutrition is preferred

(opinion). There is insufficient evidence documenting the efficacy of intraperitoneally

administered amino acids (evidence). Polyglucose solutions are a welcome addition to the

treatment of children on NIPD, when ultrafiltration and/or solute removal are insufficient

(evidence). However, in the absence of any reported long-term experience in children their

use must be closely monitored (opinion). Bicarbonate would appear to be the preferred buffer

for peritoneal dialysis in children, but more in vivo studies are required before it replaces the

present lactate containing solutions (evidence/opinion).

Running title: PD fluids in children

Key words: peritoneal dialysis solutions, children, glucose, calcium, amino acids,

icodextrin, bicarbonate.

2

Commencing chronic peritoneal dialysis in an individual child requires the choice of

an appropriate dialysis solution from the large number that are available. The choice is usually

straightforward in a child commencing dialysis, but the choice of solution is more important

and difficult in the case of patients with complications, such as ultrafiltration failure and

malnutrition. In addition to the traditional glucose solutions there are now a number of

different osmotic agents and buffers available.

The European Pediatric Peritoneal Working Group (EPPWG) was established in 1999

by pediatric nephrologists with a major interest in peritoneal dialysis and has already initiated

guidelines on commencing elective chronic peritoneal dialysis [1]. One of the functions of the

group is to establish expert guidance in important clinical areas associated with peritoneal

dialysis in conjunction with other members of the multidisciplinary team. These guidelines

were initiated and discussed at meetings of the group and developed by e-mail discussion to

develop consensus of opinion based upon cumulative clinical experience and reported studies.

This paper will discuss the advantages and disadvantages of the dialysis solutions available

and highlight any reported pediatric experience, and provides recommendations for the

choice.

Attempts have been made to base these recommendations on evidence obtained from

the published literature. It should be kept in mind, however, that the number of available

pediatric studies in this field and the size of these studies does not allow development of

evidence-based recommendations on a firm basis. Multicenter studies on a larger scale have

to be conducted to provide more evidence for the recommendations.

Osmotic agents

3

Glucose

From the start of peritoneal dialysis as a therapy for renal failure glucose has been

used as the osmotic agent. Table I gives information on the composition and some properties

of conventional dialysis solutions commonly prescribed. The low pH and the high osmolarity

are prominent characteristics. The high osmolarity of conventional dialysis solutions is caused

by the glucose content. The low pH of these solutions will be discussed later in this paper.

The high glucose concentration gives rise to a high glucose absorption, adding calories to the

patient on the one hand, but causing hyperlipidemia and hyperinsulinemia on the other.

A large number of studies, both in vitro and in vivo, have been published proving

detrimental effects of these solutions on the (intra)peritoneal cells. These effects have recently

been extensively reviewed by Krediet et al [2]. Mesothelial cells are inhibited with respect to

their proliferation and cytokine production [3-5]. In vitro research demonstrated necrosis of

human monocytes after exposure to dialysis solutions [6].

The high glucose concentration in the dialysis solution leads to irreversible

glycosylation of proteins [7-9]. Subsequently, glucose degradation products and advanced

glycosylation end products are formed, which may contribute to the functional deterioration

of the peritoneal membrane in long-term dialysis [10-13]. These products have been shown to

affect cellular growth and induce functional changes in monocytes and neutrophils.

In order to avoid the possibility of functional deterioration of the peritoneal membrane

due to the high glucose content and low pH of these solutions, the solution with the lowest

glucose should be used in daily practice. Regular assessment of both dietary fluid intake and

urinary output should be performed. In infants high glucose concentrations can rapidly lead to

dehydration and their use needs careful supervision.

4

Because of the unfavorable properties of glucose as an osmotic agent a number of

alternative osmotic agents have been studied and will be discussed later. Experience with

some of these solutions is limited, particularly with respect to specific pediatric data.

A few remarks have to be made on the calcium content of the dialysis fluid. The

standard calcium concentration is 1.75 mmol/L (Table I). The use of dialysis solutions

containing this concentration frequently leads to hypercalcemia if patients are simultaneously

treated with Ca-containing phosphate binders and vitamin D analogs. Therefore, low calcium

dialysis solutions (1.25 mmol/l) have been developed, aiming to allow higher dosage of oral

phosphate-binding calcium salts, and to minimize hypercalcemia. Although the experience in

children with these solutions is very limited [14], the results and the experience from adult

studies confirm this theory [15-17]. On the contrary, it should be remembered that in adult

patients there is a certain risk that severe secondary hyperparathyroidism with long-term low-

calcium therapy will develop, even if normocalcemia is obtained [18-20]. In children a

slightly positive calcium balance might be needed because of the growing skeleton. Although

there is no specific pediatric literature on this topic, it can be assumed that this may also occur

in children.

Recommendation

Glucose is the standard osmotic agent for peritoneal dialysis in children. (evidence) The

lowest glucose concentration needed should be used. (opinion) Low calcium solution (1.25

mmol/L) should be applied, wherever possible, with careful monitoring of parathyroid

hormone levels at least every 3 months. (opinion)

Amino acids

5

Amino acids, administered once daily for a 4-6 hour dwell, are claimed to supply

nutrition to dialysis patients and to compensate for peritoneal protein losses [21-26]. Although

in these studies statistically significant rises in serum albumin, pre-albumin, transferrin, and

mid arm muscle circumference have been reported, it is still to be established that amino acids

contribute to an improved long-term nutritional status. Conversely, amino acids tend to

worsen acidosis and to increase urea load. The composition of the only presently available

preparation is given in Table II. There are a number of publications describing the experience

with amino acid solutions in children [27-31]. The most extensive studies have been

performed by Canepa and colleagues. In a study in 8 children for a period of 6 months, in

which the amino acid solution was mixed with a glucose solution in a continuous peritoneal

dialysis (CPD) regimen, an improvement of anthropometric parameters, like mid arm

circumference and weight-for height percentile occurred [30]. There were no modifications in

blood urea nitrogen levels, nor in serum levels of total proteins and albumin. The authors

concluded that the main advantages of administering supplemental amino acids by the

peritoneal route are the good compliance without modification of the normal dialysis

procedure, and the fact that the supplemental nitrogen by amino acids carries no additional

phosphorus. Especially this latter property seems to be important, since phosphate control in

children is often a problem, partly caused by the relatively high protein intake. Amino acid

dialysis solutions are relatively expensive. Whenever possible, the enteral route is preferred to

correct malnutrition.

Recommendation

The use of amino acid containing dialysis fluids can be considered in malnourished children,

although aggressive enteral nutrition is preferred. (opinion) There is insufficient evidence

documenting the efficacy of intraperitoneally administered amino acids. (evidence)

6

Polyglucose

Polyglucose solutions have been extensively studied both in adults and in children.

The commercially available polyglucose solution (icodextrin 7.5%) contains glucose

polymers with an average molecular weight of 16,200 D. The composition and some of the

properties are given in Table III. Because of the low adsorption of these large-molecular

weight substances ultrafiltration is sustained making icodextrin very suitable for long-time

dwell periods [32-34]. In adult patients improved ultrafiltration during a day-time dwell was

obtained with icodextrin compared to glucose 1.36% [35]. De Boer et al. studied the effects of

icodextrin in 11 children who were being treated with a NIPD (nightly intermittent peritoneal

dialysis) regimen [36]. Icodextrin was compared with glucose 1.36% and glucose 3.86% for a

12-hour dwell period. Net ultrafiltration obtained with the icodextrin solution was similar to

that obtained with the glucose 3.86% solution, and significantly higher than that observed

with the glucose 1.36% solution. In these children the daily administration of icodextrin added

a mean of 0.52 (standard deviation 0.07) to weekly KT/V urea, because of the longer time on

dialysis. The sustained but slow ultrafiltration is illustrated by the absence of a drop of

dialysate sodium concentration in the group treated with icodextrin, a phenomenon normally

occurring in patients treated with 3.86% glucose, who are presumed to have a normally

functioning peritoneal membrane [37,38]. In the 4-hour peritoneal equilibration test net

ultrafiltration is much lower than using a glucose 3.86% glucose solution [39].

The potential toxicity of icodextrin solutions has been studied both in adults and in

children and has provided similar results [32,36,40]. In a study in which icodextrin was

7

prescribed for the daytime dwell in children on NIPD for 6 weeks, icodextrin blood levels

rapidly increased to a steady state reached after 2 weeks [36]. Two weeks after the

discontinuation of the study icodextrin was not detectable in the blood anymore. Blood levels

of the main metabolites of icodextrin (maltose, maltotriose, and maltotetraose) followed a

similar pattern. Concentrations were identical to those measured in adult patients [32,40]. In

some patients hypersensitivity reactions towards icodextrin have been reported [41-43]. In the

one pediatric study a hypersensitivity reaction was observed in one out of 11 patients [36]. In

adult patients long-term experience with icodextrin is increasing; in children this is still very

limited.

Recommendation

Polyglucose solutions are a welcome addition to the treatment of children on NIPD, when

ultrafiltration and/or solute removal are insufficient. (evidence) However, in the absence of

any reported long-term experience in children their use must be closely monitored. (opinion)

Other osmotic agents

Although literature is available on the use of glycerol [44-48] and oligopeptides [49-

51] as an osmotic agent, their application is still considered experimental. Dialysis fluids

containing these agents are not commercially available and hence they are not recommended

for application in children.

Buffers

8

Acetate

Acetate, which was the standard buffer in the early peritoneal dialysis solutions, has

been completely abolished because of its strong association with the development of

sclerosing peritonitis [52,53].

Lactate

Lactate is currently the standard buffer applied in dialysis solutions. Lactate was

chosen because solutions containing mixtures of bicarbonate, calcium, and glucose cause the

formation of insoluble calcium salts. Under normal conditions lactate is regularly

metabolized, but is stimulates collagen synthesis by fibroblasts. On the other hand sterilizing

these solutions at physiological pH leads to caramelization of glucose. Therefore pH of

standard peritoneal dialysis solutions varies between 5.0 and 6.5 (Table I).

Bicarbonate

The number of reports using bicarbonate as a more physiological buffer is increasing.

This can only be done if a double bag is created, one side containing glucose and calcium, and

the other containing sodium bicarbonate. These bags have to be mixed shortly before

administration. Bicarbonate buffered solutions have a more physiological pH (7.0-7.6) than

lactate-based solutions (5.5-6.5). The composition and some of the properties of three

commercially available bicarbonate or bicarbonate/lactate dialysis solutions is given in Table

IV.

Most of the studies performed with these solutions report positive results, when

compared to lactate-buffered dialysis solutions [54-56]. In vitro studies showed markedly

9

better preserved function of both macrophages and human peritoneal mesothelial cells [57-

61]. An effective control of acid base balance is demonstrated by several in vivo studies [62-

66]. An interesting property of this solution is the lower incidence of infusion pain [67].

Infusion pain is generally agreed to be due to the acidity of the conventional solutions. Studies

in adult patients demonstrate a clear reduction of infusion pain and discomfort. This property

is particularly important for some children. Although there is experience in the pediatric

dialysis centers using custom-made bicarbonate dialysis solutions in cases with lactate

acidosis, no papers have been published on the chronic use and effects of bicarbonate-based

peritoneal dialysate [68]. It is known that inflow pain can be treated by pH adjustment of the

dialysis fluid with bicarbonate [69]. Since in pediatric dialysis dwell times usually are very

short, the application of a pH-neutral, bicarbonate-based solution seems to be indicated. The

pediatric experience is only published in abstract-form [70,71]. In one study 5 children were

switched from lactate to bicarbonate containing dialysis solutions [70]. The duration of the

study was not mentioned. No differences with respect to adequacy, ultrafiltration, or

laboratory values were established for the two periods, but there was an important decrease in

abdominal pain during the filling phase, with a concomitant lower intraperitoneal pressure.

The second study was devoted to the characteristics of bicarbonate dialysis fluid in a

peritoneal equilibration test [71]. In 25 children peritoneal fluid kinetics and solute transport

were similar to the results obtained using traditional lactate dialysis fluid. Intraperitoneal pH

was significantly lower during the first hour with the latter dialysis fluid. More studies in

pediatric patients are urgently needed.

10

Recommendation

Bicarbonate would appear to be the preferred buffer for peritoneal dialysis in children, but

more in vivo studies are required before it replaces the present lactate based solutions.

(evidence/opinion)

Conclusion

Since the preferred treatment modality in children is NIPD, dwell times are usually

short [72]. This makes the application of a pH-neutral dialysis solution for the standard

nightly prescription highly desirable. If ultrafiltration and/or KT/V urea are insufficient using

this regimen, the addition of a long day-time dwell with polyglucose solutions should be

considered. The place of amino acid containing dialysis fluids in pediatric peritoneal dialysis

still has to be determined.

11

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peritoneal dialysis. Perit Dial Int 1991;11:179-80.

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presentation 4th European peritoneal dialysis meeting, Madrid, 2000.

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72. Fischbach M, Stefanidis C, and the European Pediatric Peritoneal Dialysis Working

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Perit Dial Int, submitted

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Table I: Composition of glucose-containing dialysis solutions.

Dianeal® PD1 CAPD 2-4® Gambrosol trio 10®

(Baxter) (Fresenius) (Gambro)

Sodium 132 134 132 mmol/l

Calcium 1.75 1.75 1.75 mmol/l

Magnesium 0.75 0.5 0.25 mmol/l

Chloride 102 103.5 96 mmol/l

Lactate 35 35 40 mmol/l

Glucose 13.6-38.6 15-42.5 15.2-38.8 g/l

Osmolality 340-483 358-512 353-492 mOsm/l

PH 5.5 5.5 6.5

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Table II: Composition of amino acid 1.1% dialysis solution (Nutrineal®, Baxter)

Essential Amino AcidsValine 1.39 g/lLeucine 1.02 g/lIsoleucine 0.85 g/lMethionine 0.85 g/lLysine 0.76 g/lThreonine 0.65 g/lPhenylalanine 0.57 g/lTryptophan 0.27 g/lHistidine 0.71 g/l

Non-Essential Amino AcidsArginine 1.07 g/lAlanine 0.95 g/lProline 0.60 g/lGlycine 0.51 g/lSerine 0.51 g/lTyrosine 0.30 g/l

ElectrolytesSodium 132 mmol/lCalcium 1.25 mmol/lMagnesium 0.25 mmol/lChloride 105 mmol/lLactate 40 mmol/l

Osmolarity 365 mOsm/l

PH 6.7

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Table III: Composition of polyglucose (icodextrin 7.5%) dialysis solution(Extraneal®,

Baxter).

Sodium 133 mmol/l

Calcium 1.75 mmol/l

Magnesium 0.25 mmol/l

Chloride 96 mmol/l

Lactate 40 mmol/l

Icodextrin 75 g/l

Osmolarity 284 mOsm/l

PH 5.2

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Table IV: Composition of bicarbonate-containing dialysis solutions.

Physioneal® Stay●Safe®

(Baxter) (Fresenius)

Sodium 132 134 mmol/l

Calcium 1.25 1.75 mmol/l

Magnesium 0.25 0.5 mmol/l

Chloride 95 104.5 mmol/l

Bicarbonate 25 34 mmol/l

Lactate 15 0 mmol/l

Glucose 13.6-38.6 15-42.5 g/l

Osmolarity 344-483 358-511 mOsm/l

pH 7.0-7.4 7.0-7.6

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