Aggressive or moderate fluid resuscitation in acute pancreatitis

BACKGROUND: Early aggressive hydration is widely recommended for the management of acute pancreatitis, but evidence for this practice is limited. METHODS: At 18 centers, we randomly assigned patients who presented with acute pancreatitis to receive goal-directed aggressive or moderate resuscitation...

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Autores: Madaria, Enrique de, Buxbaum, James L., Maisonneuve, Patrick, García García de Paredes, Ana, Zapater, Pedro, Guilabert, Lucía, Vaillo-Rocamora, Alicia, Rodríguez-Gandía, Miguel Á., Donate-Ortega, Jesús, Lozada-Hernández, Edgard E., Collazo Moreno, Alan J.R., Lira-Aguilar, Alba, Llovet, Laura P., Mehta, Rajiv, Tandel, Raj, Navarro, Pablo, Sánchez-Pardo, Ana M., Sánchez-Marin, Claudia, Cobreros, Marina, Fernández-Cabrera, Idaira, Casals-Seoane, Fernando, Casas Deza, Diego, Lauret-Braña, Eugenia, Martí-Marqués, Eva, Camacho-Montaño, Laura M., Ubieto, Verónica, Ganuza, Mikel, Bolado Concejo, Federico, ERICA Consortium
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Universidad Pública de Navarra
Repositorio:Academica-e. Repositorio Institucional de la Universidad Pública de Navarra
OAI Identifier:oai:academica-e.unavarra.es:2454/48332
Acceso en línea:https://hdl.handle.net/2454/48332
Access Level:acceso abierto
Palabra clave:Fluid resuscitation
Acute pancreatitis
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spelling Aggressive or moderate fluid resuscitation in acute pancreatitisMadaria, Enrique deBuxbaum, James L.Maisonneuve, PatrickGarcía García de Paredes, AnaZapater, PedroGuilabert, LucíaVaillo-Rocamora, AliciaRodríguez-Gandía, Miguel Á.Donate-Ortega, JesúsLozada-Hernández, Edgard E.Collazo Moreno, Alan J.R.Lira-Aguilar, AlbaLlovet, Laura P.Mehta, RajivTandel, RajNavarro, PabloSánchez-Pardo, Ana M.Sánchez-Marin, ClaudiaCobreros, MarinaFernández-Cabrera, IdairaCasals-Seoane, FernandoCasas Deza, DiegoLauret-Braña, EugeniaMartí-Marqués, EvaCamacho-Montaño, Laura M.Ubieto, VerónicaGanuza, MikelBolado Concejo, FedericoERICA ConsortiumFluid resuscitationAcute pancreatitisBACKGROUND: Early aggressive hydration is widely recommended for the management of acute pancreatitis, but evidence for this practice is limited. METHODS: At 18 centers, we randomly assigned patients who presented with acute pancreatitis to receive goal-directed aggressive or moderate resuscitation with lactated Ringer’s solution. Aggressive fluid resuscitation consisted of a bolus of 20 ml per kilogram of body weight, followed by 3 ml per kilogram per hour. Moderate fluid resuscitation consisted of a bolus of 10 ml per kilogram in patients with hypovolemia or no bolus in patients with normovolemia, followed by 1.5 ml per kilogram per hour in all patients in this group. Patients were assessed at 12, 24, 48, and 72 hours, and fluid resuscitation was adjusted according to the patient’s clinical status. The primary outcome was the development of moderately severe or severe pancreatitis during the hospitalization. The main safety outcome was fluid overload. The planned sample size was 744, with a first planned interim analysis after the enrollment of 248 patients. RESULTS: A total of 249 patients were included in the interim analysis. The trial was halted owing to between-group differences in the safety outcomes without a significant difference in the incidence of moderately severe or severe pancreatitis (22.1% in the aggressive-resuscitation group and 17.3% in the moderate-resuscitation group; adjusted relative risk, 1.30; 95% confidence interval [CI], 0.78 to 2.18; P=0.32). Fluid overload developed in 20.5% of the patients who received aggressive resuscitation and in 6.3% of those who received moderate resuscitation (adjusted relative risk, 2.85; 95% CI, 1.36 to 5.94, P=0.004). The median duration of hospitalization was 6 days (interquartile range, 4 to 8) in the aggressive-resuscitation group and 5 days (interquartile range, 3 to 7) in the moderate-resuscitation group. CONCLUSIONS: In this randomized trial involving patients with acute pancreatitis, early aggressive fluid resuscitation resulted in a higher incidence of fluid overload without improvement in clinical outcomes.Supported by grants from Instituto de Salud Carlos III (PI19/01628, co-funded by the European Commission, European Regional Development Funds), the Spanish Association of Gastroenterology (Gonzalo-Miño 2019), and ISABIAL (Instituto de Investigación Sanitaria y Biomédica de Alicante) (UGP-20-117). Mr. Maisonneuve was supported by the Italian Ministry of Health, Ricerca Corrente, and 5x1000 funds.Massachusetts Medical SocietyCiencias de la SaludOsasun Zientziak2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/ziphttps://hdl.handle.net/2454/48332reponame:Academica-e. Repositorio Institucional de la Universidad Pública de Navarrainstname:Universidad Pública de NavarraInglésinfo:eu-repo/grantAgreement/ISCIII/Plan Estatal de Investigación Científica y Técnica y de Innovación 2017-2020 (ISCIII)/PI19%2F01628© 2022 Massachusetts Medical Society. All rights reserved.info:eu-repo/semantics/openAccessoai:academica-e.unavarra.es:2454/483322026-06-17T12:41:47Z
dc.title.none.fl_str_mv Aggressive or moderate fluid resuscitation in acute pancreatitis
title Aggressive or moderate fluid resuscitation in acute pancreatitis
spellingShingle Aggressive or moderate fluid resuscitation in acute pancreatitis
Madaria, Enrique de
Fluid resuscitation
Acute pancreatitis
title_short Aggressive or moderate fluid resuscitation in acute pancreatitis
title_full Aggressive or moderate fluid resuscitation in acute pancreatitis
title_fullStr Aggressive or moderate fluid resuscitation in acute pancreatitis
title_full_unstemmed Aggressive or moderate fluid resuscitation in acute pancreatitis
title_sort Aggressive or moderate fluid resuscitation in acute pancreatitis
dc.creator.none.fl_str_mv Madaria, Enrique de
Buxbaum, James L.
Maisonneuve, Patrick
García García de Paredes, Ana
Zapater, Pedro
Guilabert, Lucía
Vaillo-Rocamora, Alicia
Rodríguez-Gandía, Miguel Á.
Donate-Ortega, Jesús
Lozada-Hernández, Edgard E.
Collazo Moreno, Alan J.R.
Lira-Aguilar, Alba
Llovet, Laura P.
Mehta, Rajiv
Tandel, Raj
Navarro, Pablo
Sánchez-Pardo, Ana M.
Sánchez-Marin, Claudia
Cobreros, Marina
Fernández-Cabrera, Idaira
Casals-Seoane, Fernando
Casas Deza, Diego
Lauret-Braña, Eugenia
Martí-Marqués, Eva
Camacho-Montaño, Laura M.
Ubieto, Verónica
Ganuza, Mikel
Bolado Concejo, Federico
ERICA Consortium
author Madaria, Enrique de
author_facet Madaria, Enrique de
Buxbaum, James L.
Maisonneuve, Patrick
García García de Paredes, Ana
Zapater, Pedro
Guilabert, Lucía
Vaillo-Rocamora, Alicia
Rodríguez-Gandía, Miguel Á.
Donate-Ortega, Jesús
Lozada-Hernández, Edgard E.
Collazo Moreno, Alan J.R.
Lira-Aguilar, Alba
Llovet, Laura P.
Mehta, Rajiv
Tandel, Raj
Navarro, Pablo
Sánchez-Pardo, Ana M.
Sánchez-Marin, Claudia
Cobreros, Marina
Fernández-Cabrera, Idaira
Casals-Seoane, Fernando
Casas Deza, Diego
Lauret-Braña, Eugenia
Martí-Marqués, Eva
Camacho-Montaño, Laura M.
Ubieto, Verónica
Ganuza, Mikel
Bolado Concejo, Federico
ERICA Consortium
author_role author
author2 Buxbaum, James L.
Maisonneuve, Patrick
García García de Paredes, Ana
Zapater, Pedro
Guilabert, Lucía
Vaillo-Rocamora, Alicia
Rodríguez-Gandía, Miguel Á.
Donate-Ortega, Jesús
Lozada-Hernández, Edgard E.
Collazo Moreno, Alan J.R.
Lira-Aguilar, Alba
Llovet, Laura P.
Mehta, Rajiv
Tandel, Raj
Navarro, Pablo
Sánchez-Pardo, Ana M.
Sánchez-Marin, Claudia
Cobreros, Marina
Fernández-Cabrera, Idaira
Casals-Seoane, Fernando
Casas Deza, Diego
Lauret-Braña, Eugenia
Martí-Marqués, Eva
Camacho-Montaño, Laura M.
Ubieto, Verónica
Ganuza, Mikel
Bolado Concejo, Federico
ERICA Consortium
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Ciencias de la Salud
Osasun Zientziak
dc.subject.none.fl_str_mv Fluid resuscitation
Acute pancreatitis
topic Fluid resuscitation
Acute pancreatitis
description BACKGROUND: Early aggressive hydration is widely recommended for the management of acute pancreatitis, but evidence for this practice is limited. METHODS: At 18 centers, we randomly assigned patients who presented with acute pancreatitis to receive goal-directed aggressive or moderate resuscitation with lactated Ringer’s solution. Aggressive fluid resuscitation consisted of a bolus of 20 ml per kilogram of body weight, followed by 3 ml per kilogram per hour. Moderate fluid resuscitation consisted of a bolus of 10 ml per kilogram in patients with hypovolemia or no bolus in patients with normovolemia, followed by 1.5 ml per kilogram per hour in all patients in this group. Patients were assessed at 12, 24, 48, and 72 hours, and fluid resuscitation was adjusted according to the patient’s clinical status. The primary outcome was the development of moderately severe or severe pancreatitis during the hospitalization. The main safety outcome was fluid overload. The planned sample size was 744, with a first planned interim analysis after the enrollment of 248 patients. RESULTS: A total of 249 patients were included in the interim analysis. The trial was halted owing to between-group differences in the safety outcomes without a significant difference in the incidence of moderately severe or severe pancreatitis (22.1% in the aggressive-resuscitation group and 17.3% in the moderate-resuscitation group; adjusted relative risk, 1.30; 95% confidence interval [CI], 0.78 to 2.18; P=0.32). Fluid overload developed in 20.5% of the patients who received aggressive resuscitation and in 6.3% of those who received moderate resuscitation (adjusted relative risk, 2.85; 95% CI, 1.36 to 5.94, P=0.004). The median duration of hospitalization was 6 days (interquartile range, 4 to 8) in the aggressive-resuscitation group and 5 days (interquartile range, 3 to 7) in the moderate-resuscitation group. CONCLUSIONS: In this randomized trial involving patients with acute pancreatitis, early aggressive fluid resuscitation resulted in a higher incidence of fluid overload without improvement in clinical outcomes.
publishDate 2022
dc.date.none.fl_str_mv 2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2454/48332
url https://hdl.handle.net/2454/48332
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv info:eu-repo/grantAgreement/ISCIII/Plan Estatal de Investigación Científica y Técnica y de Innovación 2017-2020 (ISCIII)/PI19%2F01628
dc.rights.none.fl_str_mv © 2022 Massachusetts Medical Society. All rights reserved.
info:eu-repo/semantics/openAccess
rights_invalid_str_mv © 2022 Massachusetts Medical Society. All rights reserved.
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/zip
dc.publisher.none.fl_str_mv Massachusetts Medical Society
publisher.none.fl_str_mv Massachusetts Medical Society
dc.source.none.fl_str_mv reponame:Academica-e. Repositorio Institucional de la Universidad Pública de Navarra
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instname_str Universidad Pública de Navarra
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