Original Title: Eficacia, efectividad, seguridad y eficiencia de las soluciones coloides para el manejo de pacientes en edad pediátrica

Authors' objectives: The goal is identify the colloid solution more effective and safe in pediatric surgery and describe publications that perform economic evaluation of different therapeutic alternatives with colloids.

Authors' results and conclusions: In the comparison between tetrastarch and albumin we found no differences in indicators of bleeding, except fibrinogen favouring albumin, or indicators of coagulation except platelet counts which favours albumin, or indicators of renal failure except intraoperative urea favouring albumin and in the intraoperative urine volume favouring tetrastarch; we found no differences in ICU stay or mortality. If we include Van der Linden 20151 we found that bleeding indicators favour the tetrastarch and no difference in hospital stay. In the comparison between gelatine and tetrastarch we found no differences in bleeding indicators; or indicators of coagulation except clotting time and clot propagation angle alpha-clot favouring gelatin; or indicators of renal failure; stay; or adverse events. In the comparison between gelatin and albumin we found no differences in bleeding indicators; or coagulation indicators except maximum clot firmness favouring gelatin; or adverse effects. In the comparison between hydroxyethyl starch and dextran we find a single study that found no difference for bleeding indicators or for adverse effects. The approximate cost per liter in Spain is €421 for albumin, 24€ for hydroxyethyl starch, 10€ for gelatin and 8€ for dextran. Considering active ingredient costs only €2622 for albumin, €265 for hydroxyethyl starch, €239 for gelatin and €76 for dextran.

Authors' recommendations: • Given the experience in its use and safety, in all periods of paediatric age, especially in premature infants and neonates, albumin could be considered as the reference colloid for the treatment of hypovolemia in elective surgery. Grade of recommendation A. • In paediatric no cardiac elective surgery, excluding premature infants and neonates, succinylated gelatin or hydroxyethyl starch 130/0,4 or 0,42 at 6% may be used for the treatment of hypovolemia. Grade of recommendation A. • In major elective paediatric surgery, in case of use of hydroxyethyl starch 130/0,4 or 0,42 at 6%, with no contraindications such as kidney failure, other renal disorders, hepatic, haematological or previous allergic, and which is not foreseen to use plasma expanders in repeated doses, the dose should not exceed 15-20 ml/kg. Grade of recommendation A. • In elective cardiac surgery with cardiopulmonary bypass in children over 1 month, the use of gelatines can be considered as an alternative to the use of albumin. Grade of recommendation A.

Authors' methods: A systematic review of the scientific literature with the following research question is performed: “in pediatric patients, premature and neonates undergoing elective surgery what or which of colloids is the most effective, safe and efficient?” The variables of interest of safety, efficacy and effectiveness are: mortality, bleeding, coagulation disorders, acute renal failure, edema, hypoalbuminemia, pruritus and anaphylactic reactions. The literature search will be made in biomedical databases: MEDLINE (PubMed), EMBASE, Cochrane Library and the CRD databases (DARE, NHS EED and HTA). The quality of the studies included in this review will be evaluated using the computer application developed by Osteba. Meta-analysis of the studies included for those variables with sufficient data of at least two studies are conducted. Recommendations are made by formal assessment or reasoned judgement by a panel of experts rating the quality of evidence following the system of the Scottish Intercollegiate Guidelines Network (SIGN). Finally, the text was presented to a group of external reviewers for reviewing it systematically.

Authors' identified further research: • There is no studies on the safety of these products in repeated doses (successive expansions of plasma), after overcoming the recommended dose, or at what time would be indicated to repeat, so that future research could focus on these aspects. • We not found consistent evidence on the efficacy and safety of using dextran and new gelatines, future research could be directed to assess the risk-benefit balance for use in paediatric patients for the treatment of hypovolemia in elective surgery. • There is few evidence on the use of synthetic colloids in neonates and premature infants, so it is recommended that future research include these population segments and present the results disaggregated. • In future research on colloids it is recommended that the research question focuses on a particular time of the surgical procedure: extracorporeal circulation pump priming (if applicable), intraoperative or postoperative patient care. • It would be interesting to conduct an investigation by systematic review of fluid therapy in paediatrics, including colloids and crystalloids, which probably require the use of network meta-analysis methodology. • It would be interesting to perform specific research on paediatric fluid therapy during urgent and emergency surgery.

Project Status: Completed

Year Published: 2016

URL for published report: http://www.iacs.es/wp-content/uploads/2019/09/13_IACS_2015_FLUIDOTERAPIA_DEF_NIPO_MOD.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Health Sciences Institute in Aragon (IACS)

Contact Address: Avda, San Juan Bosco, 13, planta 2

Contact Name: María Pilar Calvo Pérez

Contact Email: direccion.iacs@aragon.es