Strategies for preventing and treating IFALD
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1 Strategies for preventing and treating IFALD Dr Sue Beath The Liver Unit (including small bowel transplantation) Birmingham Children s Hospital
2 Intestinal failure associated liver disease IFALD in children is a manifestation of a systemic inflammatory response syndrome (SIRS) often triggered by sepsis Scenarios which increase the intensity of SIRS surgery invasive care NICU/PICU Also known as Parenteral Nutrition Associated Cholestastis (PNAC), but IFALD is to be preferred as it focuses attention on the whole context of intestinal failure and not just the PN infusions
3 Why worry about intestinal failure associated liver disease over 1000 children on PN per year and at risk of IFALD about half have abnormal liver function of those who are referred for small bowel transplant half have advanced liver disease (type IFALD; bilirubin >100 micromol/l) IFALD (esp type ) increases the risk of mortality neonates and children are more susceptible to IFALD than adults liver transplantation is an option but v. high risk in context of IF
4 Pathophysiology of IFALD = twin process 1. Exogenous factors bacterial endotoxin [Klosters] and necrotising enterocolitis pro-inflammatory mediators cytotoxic reactions disruption of biliary system transporters by endotoxin, cytokines excess nutrients overwhelming normal metabolic processes 2. Endogenous patient related factors prematurity and immature homeostatic mechanisms [Hermans, Beath, Robinson, Hsieh] malnutrition - depletion of innate detoxifiers glutathione portals of entry for infection (ITU +/- surgery) Necrotising enterocolitis [Duro] Gastroschisis [Dell Olio]
5 IFALD literature review The following search terms were used to identify published reports: Intestinal failure associated liver disease (n= 4) Parenteral Nutrition Associated Cholestastis (n=18) Liver disease and intestinal failure (n=1177; 277 reviews, 20 remained after excluding non-human, or adult focused papers and papers previously identified by the earlier search terms). 5 reports where IFALD or PNAC was the main focus
6 Evidence level assigned according to the SIGN criteria 4 = EL 1 randomised controlled studies [Harbour & Miller] 1 = EL 2 cohort studies, non randomised interventions 16 = EL surveys, non -experimental The subjects of the papers were in the following categories: IFALD improved or prevented by drugs IFALD improved or prevented by modifications to the PN solution IFALD improved by good clinical practice
7 Drug treatment of IFALD Reference Evidence level 1.High dose (12.5mg/kg/dose) oral erythromycin for dysmotility in babies Ng et al Ursodeoxycholic acid 0mg/kg/day prevents IFALD type 1 (bilirubin <50µmol/l) and improves established IFALD (types 2 & ).Cholecystokin is not useful in preventing IFALD in noenates 4. Metronidazole 25-50mg/kg/day prevents IFALD type 1 and reduces type IFALD Arslanoglu 2008 Chen 2004 De Marco 2006 Teitlebaum 2005 Kubota Sigalet 1 1
8 IFALD improved or prevented by modifications to the PN solution 1. reducing soya based oil in PN a) makes no difference to LFTs in infants on long term PN b) improves cholestasis in children older than 6 months 2. using lipid PN enriched with fish oil improves IFALD: omegaven omegaven omegaven SMOF Lipid Reference Goulet 1999 Rollins 2010 Siaglet Puder Gura None in children ESPGHAN guidance Evidence level. limiting lipid in PN to less 4 than.5mg/kg/d 4. Cycling PN reduced risk of IFALD Jensen Taurine supplements prevents Type 1 and reduces type IFALD in NEC Spencer 2009
9 Risk factor for IFALD and good clinical practice Reference Prematurity Fitzgibbons 2010 Robinson 2008 Hsieh 2009 Beath 1996 Evidence level Need for abdominal surgery Duro 2011 Need for stoma Andorsky 2001 Less than 0cm small bowel Peyret 2011 History of gastroschisis and dsymotility History of severe NEC Robinson 2008 Early colonisation with pseudomonas or enterobacter CRBSI within 28 days of birth Hermans 2007 Sondheimer 1998 Recurrent CRBSI Beath 1996 Hsieh 2009 Wales 2005 Andorsky 2001 Dell Olio 2009 Duro 2011 Pierro 1998
10 medical management algorithms for IFALD a) with IFALD nil or mild type 1 IFALD b) worsening IFALD (type 2/) Abnormal LFTs; bilirubin rising Abn LFTs; bilirubin >50mmol/dL 1. Screen for infection and primary liver disease 2. Start antibiotics if infection likely. Commence enteral nutrition (EN) unless concerns about NEC & erythromycin [Ng] 4. Start ursodeoxycholic acid p.o. [Arslanoglu] 5. Start cycling PN asap 6. Use amino acid solns with taurine supplements [Spencer] 7. Discuss with PN prescription with NST 1. Screen for infection, consider replacement of feeding catheter. 2. Review hygiene measures for feeding catheter.. reduce over exposure to PN calories [ESPGHAN] 4. Consider second line iv lipid with reduced Linolenic acid. 5. Consider surgical strategies to enhance intestinal rehab &EN. 6. Treat bacterial overgrowth 7. Stop intravenous lipid infusion for 1-2 weeks
11 Neonatal and surgical management algorithms in IFALD Abnormal LFTs in surgical neonates 1.Screen for infection and liver disease 2.Start antibiotics if infection likely.screen and treat for intestinal obstruction 4.Restore intestinal continuity at an opportunity 5.Discuss with NST to reduce over exposure to PN calories. 6.Start Ursodeoxycholic acid 0mg/day early Neonate or infant with high nasogastic losses Screen for and treat intestinal obstruction. Treat dysmotilty with high dose oral erythromycin 12.5mg/kg/dose [Ng] Worsening IFALD 1.Discuss with NST to reduce over exposure to PN calories 2.Consider surgical strategies to enhance intestinal rehabilitation inc restoration of bowel continuity. Children older than 6 months.bowel lengthening and tapering may be an option 4.Review hygiene measures for feeding catheter and consider replacement of feeding catheter
12 IFALD in setting of long term intestinal failure 1. Discharge to home with NST supporting care of Home PN [Puntis, Hess] 2. Review prescription to reduce over exposure to PN calories [ESPGHAN]. Introduce lipid free days / Consider alternative type of PN lipid 4. Screen for infection and treat as indicated, consider replacement of feeding catheter. 5. Consider alternative type of PN lipid If IFALD worsens or does not resolve Consult specialist centre for suitability of liver +/- small bowel transplant
13 Currently the only EL 1 studies in IFALD are: High-dose oral erythromycin (12.5 mg/kg/dose) to be used as a rescue measure for VLBW infants who fail to establish adequate EN and in whom intestinal obstruction has been excluded EL1+ Ng 2007 UDCA p.o. should be routinely administered to infants who are receiving minimal oral/enteral feeding EL1+ Arslanoglu 2008 Cholecystokin is not useful in preventing IFALD in neonates EL1++ Teitlebaum 2005 Reducing soya based oil in lipid component of PN makes no difference to LFTs in infants on long term PN EL1- Goulet 1999
14 Reference Population Ng PC Gastroent 2007 Arslanoglu S JPGN 2008 Teitlebuam DH Pediatrics 2005 Goulet O Am J Clin Nutr 1999 VLBW infants recruited from 1 centre in Hong Kong Pre-term infants recruited from 1 centre in Milan Neonates recruited from 8 neonatal tertiary care centres in USA Infants on long term PN Recruited from Intervention Cases Control data High dose 91 Double oral 12.5mg blinded erythromycin randomized from day control s 15 placebo 91 controlled UDCA for wks from birth CCK-OP 0.04microg ram /kg/dose Olive oil vs. soy bean lipid 15 control s control s control s 9 study Double blind placebo control Double blinded randomized placebo control Randomiz -ed eligible patients Study rating Outcomes reported 1++ The treatment group had a lower frequency of IFALD (18/91 vs 7/91 p=0.00); shorter duration of PN (2 versus days p<0.001), septacaemic episodes >2 reduced in treatment group (p=0.0) 1+ Significant reduction of GGT in treated group, trend to earlier weaning from PN and reduced fat excretion. 1++ CCK-OP did not reduce incidence of IFALD 1- No significant diff in bilirubin. ALT. AST. Sign treatment effect on total cholesterol and LDL
15 Parenteral nutrition in pre-term babies and infants a Decision Tree Is Intestinal failure likely >28 days? Is the GI tract functioning sufficiently for absorption of some nutrients? Yes No Continue PN, either as an alternative, or a supplement, if clinically appropriate and re-challenge with EN later Has oro/naso/gastric feeding +/- erythromycin been attempted? 1 Has ursodeoxycholic acid 0mg/kg been started? 2 Consider erythromycin if clinically appropriate eg if dysmotile but no evidence of intestinal obstruction Ng PC, et al High-dose oral erythromycin decreased the incidence of parenteral nutritionassociated cholestasis in preterm infants. Gastroenterology. 2007;12: Arslanoglu S et al Ursodeoxycholic acid treatment in preterm infants: a pilot study for the prevention of cholestasis associated with total parenteral nutrition. J Pediatr Gastroenterol Nutr. 2008;46: Guidelines on paediatric parenteral nutrition J Pediatr Gastroenterol Nutr 2005;41;suppl 4. Sigalet D et Improvd outcomes in paediatric intestinal failure with aggressive prevention of liver disease. Eur J Pedaitr Surg 2009; 19: 48-5.
16 Parenteral nutrition in pre-term babies and infants a Decision Tree Is Intestinal failure likely >28 days? Are liver function tests normal? Yes No Continue PN with monitoring (glucose, trace elements etc) and re-consider weaning with EN Consider: 1.Screen for infection, consider replacement of feeding catheter. 2.Review hygiene measures for feeding catheter..reduce over exposure to PN calories [ESPGHAN] 4.Consider second line iv lipid with reduced Linolenic acid 4. 5.Consider surgical strategies to enhance intestinal rehab & EN. 6.Treat bacterial overgrowth 7.Stop intravenous lipid for 1-2 weeks 8.exclude congenital liver disease 1. Ng PC, et al High-dose oral erythromycin decreased the incidence of parenteral nutritionassociated cholestasis in preterm infants. Gastroenterology. 2007;12: Arslanoglu S et al Ursodeoxycholic acid treatment in preterm infants: a pilot study for the prevention of cholestasis associated with total parenteral nutrition. J Pediatr Gastroenterol Nutr. 2008;46: Guidelines on paediatric parenteral nutrition J Pediatr Gastroenterol Nutr 2005;41;suppl 4. Sigalet D et Improvd outcomes in paediatric intestinal failure with aggressive prevention of liver disease. Eur J Pedaitr Surg 2009; 19: 48-5.
17 Research Recommendations in IFALD Multicentre studies needed to achieve recruitment of 50+ subjects for: Multi-source lipids in cognitive and hepatic outcomes Erythromycin as a treatment for dysmotility in term infants and high risk groups eg in gastroschisis Biochemical markers of liver fibrosis Treatments which reduce CRBSI which is an important factor in IFALD (eg line locks) in hospitalized and home PN patients
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