Riesgos

documentados
 El riesgo de anafilaxia aumenta de manera
significativa posterior la administracion de
poligelina.

Se han encontrado un aumento significativo

en el nivel circulante de histamina y su
Anafilaxia asociación con alteraciones cardiorespiratorias
en pacientes expuestos a poligelinas

En pacientes en estado critico y en pediatricos

con infecciones graves su uso se ha asociado a
un riesgo incrementado de anafilaxia. 6-9
Trastornos de
la coagulación
• La administracion de
poligelina resulta en
hipocoagulabilidad

• La poligelina reduce los

factores de la coagulacion
VIII, I y factor de von
Willebrand e impide la
agregacion plaquetaria, la
activacion de trombina y la
polimerizacion de fibrina. 11-14
Lesión renal
• La poligelina aumenta el
riesgo de riesgo de lesion
renal aguda asi como
increment el riesgo de terapia
de remplazo renal.
• Aumenta la nefrosis osmotica
el cual cursa con alteraciones
de la funcion renal10,15-17
 Mortalidad
• Aumeta la mortalidad
intrahospitalaria durante el
tratamiento con poligelinas10

10 Bayer O, Schwarzkopf D, Doenst T, Cook D, Kabisch B, Schelenz C, Bauer M, Riedemann NC, Sakr Y, Kohl M, Reinhart K, Hartog CS. Perioperative fluid therapy with
tetrastarch and gelatin in cardiac surgery-a prospective sequential analysis*. Crit Care Med 2013;41: 2532-2542.
18 Moeller Claudia, Fleischmann Carolin, Thomas-Rueddel Daniel, Vlasakov Vlasislav, Rochwerg Bram, Theurer Philip, Gattinoni Luciano, Reinhart
Konrad, Hartog Christiane S., How safe is gelatin? a systematic review and metaanalysis of gelatin-containing plasma expanders versus crystalloids
and albumin, Journal of Critical Care (2016), doi: 10.1016/j.jcrc.2016.04.011
 • Incluyeron 30 RCT con 3629 pacientes entre los años 1976 y 2012

• 20 RCTs se realizaron pacientes quirugicos ( 1 trauma, 9 cirugia

cardiovascular, 10 en tros procedimientos quirurgicos electivos)

• 3 RCTs se llevaron acabo en pacientes criticos

• 7 RCTs en pediatricos ( 4 pediatricos infecciones graves o choque

septico, 2 en pacientes pediatricos quirurgicos y 1 preterminos)

Moeller Claudia, Fleischmann Carolin, Thomas-Rueddel Daniel, Vlasakov Vlasislav, Rochwerg Bram, Theurer Philip, Gattinoni Luciano, Reinhart
Konrad, Hartog Christiane S., How safe is gelatin? a systematic review and metaanalysis
of gelatin-containing plasma expanders versus crystalloids and albumin, Journal of Critical Care (2016), doi: 10.1016/j.jcrc.2016.04.011
 Conclusiones.
• La poligelina aumenta el riesgo de anafilaxia.

• Aumenta la mortalidad, aumentando el riego de falla renal,

hemorragia.

• Como expansor de volumen es costoso e inseguro.

• Existen alternativas con menos riesgos y mas accesibles en cuanto al

costo
Moeller Claudia, Fleischmann Carolin, Thomas-Rueddel Daniel, Vlasakov Vlasislav, Rochwerg Bram, Theurer Philip, Gattinoni Luciano, Reinhart
Konrad, Hartog Christiane S., How safe is gelatin? a systematic review and metaanalysis
of gelatin-containing plasma expanders versus crystalloids and albumin, Journal of Critical Care (2016), doi: 10.1016/j.jcrc.2016.04.011
 Proscritos en EEUU y UE
• Retirado por la FDA desde 1978 por el riesgo de
sangrado y anafilaxia

• Retirado por la EMA (Agencia de medicamentos

Europea) en el 2013

19 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration 21 CFR Part 216 [Docket No. 98N-0655]. List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness (Federal
Register of April 7, 1978 (43 FR 14743)). Published in the Federal Register: October 8, 1998 (Volume 63, Number 195)
120 PRAC confirms that hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients. in: HES will be available in restricted
patient populations. Press release October 11th 2013.; 2013.Kastrup, M., Carl, M., Spies, C., Sander, M., Markewitz, A., Schirmer, U. Clinical impact of the publication of S3 guidelines for
intensive care in cardiac surgery patients in Germany: results from a postal survey. Acta Anaesthesiol Scand. 2013;57:206–213.
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• 10 Bayer O, Schwarzkopf D, Doenst T, Cook D, Kabisch B, Schelenz C, Bauer M, Riedemann NC, Sakr Y, Kohl M, Reinhart K, Hartog
CS. Perioperative fluid therapy with tetrastarch and gelatin in cardiac surgery-a prospective sequential analysis*. Crit Care Med
2013;41: 2532-2542.
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• 18 Moeller Claudia, Fleischmann Carolin, Thomas-Rueddel Daniel, Vlasakov Vlasislav, Rochwerg Bram, Theurer Philip, Gattinoni
Luciano, Reinhart Konrad, Hartog Christiane S., How safe is gelatin? a systematic review and metaanalysis of gelatin-containing
plasma expanders versus crystalloids and albumin, Journal of Critical Care (2016), doi: 10.1016/j.jcrc.2016.04.011
• 19 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration 21 CFR Part 216 [Docket No. 98N-0655]. List of
Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness (Federal Register of
April 7, 1978 (43 FR 14743)). Published in the Federal Register: October 8, 1998 (Volume 63, Number 195)
• 20 PRAC confirms that hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in
critically ill patients. in: HES will be available in restricted patient populations. Press release October 11th 2013.; 2013.Kastrup, M.,
Carl, M., Spies, C., Sander, M., Markewitz, A., Schirmer, U. Clinical impact of the publication of S3 guidelines for intensive care in
cardiac surgery patients in Germany: results from a postal survey. Acta Anaesthesiol Scand. 2013;57:206–213.