Aggressive or moderate fluid resuscitation in acute pancreatitis

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dc.contributor.authorMadaria, Enrique de
dc.contributor.authorBuxbaum, James L.
dc.contributor.authorMaisonneuve, Patrick
dc.contributor.authorGarcía García de Paredes, Ana
dc.contributor.authorZapater, Pedro
dc.contributor.authorGuilabert, Lucía
dc.contributor.authorVaillo-Rocamora, Alicia
dc.contributor.authorRodríguez-Gandía, Miguel Á.
dc.contributor.authorDonate-Ortega, Jesús
dc.contributor.authorLozada-Hernández, Edgard E.
dc.contributor.authorCollazo Moreno, Alan J.R.
dc.contributor.authorLira-Aguilar, Alba
dc.contributor.authorLlovet, Laura P.
dc.contributor.authorMehta, Rajiv
dc.contributor.authorTandel, Raj
dc.contributor.authorNavarro, Pablo
dc.contributor.authorSánchez-Pardo, Ana M.
dc.contributor.authorSánchez-Marin, Claudia
dc.contributor.authorCobreros, Marina
dc.contributor.authorFernández-Cabrera, Idaira
dc.contributor.authorCasals-Seoane, Fernando
dc.contributor.authorCasas Deza, Diego
dc.contributor.authorLauret-Braña, Eugenia
dc.contributor.authorMartí-Marqués, Eva
dc.contributor.authorCamacho-Montaño, Laura M.
dc.contributor.authorUbieto, Verónica
dc.contributor.authorGanuza, Mikel
dc.contributor.authorBolado Concejo, Federico
dc.contributor.authorERICA Consortium
dc.contributor.departmentCiencias de la Saludes_ES
dc.contributor.departmentOsasun Zientziakeu
dc.date.accessioned2024-06-11T16:06:20Z
dc.date.available2024-06-11T16:06:20Z
dc.date.issued2022
dc.date.updated2024-06-11T14:40:13Z
dc.description.abstractBACKGROUND: 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.en
dc.description.sponsorshipSupported 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.en
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dc.format.mimetypeapplication/zipen
dc.identifier.citationDe-Madaria, E., Buxbaum, J. L., Maisonneuve, P., García García de Paredes, A., Zapater, P., Guilabert, L., Vaillo-Rocamora, A., Rodríguez-Gandía, M. Á., Donate-Ortega, J., Lozada-Hernández, E. E., Collazo Moreno, A. J. R., Lira-Aguilar, A., Llovet, L. P., Mehta, R., Tandel, R., Navarro, P., Sánchez-Pardo, A. M., Sánchez-Marin, C., Cobreros, M. D., Fernández-Cabrera, I., Casals-Seoane, F., Casas Deza, D., Lauret-Braña, E., Martí-Marqués, E., Camacho-Montaño, L. M., Ubieto, V., Ganuza, M., Bolado, F., ERICA Consortium (2022) Aggressive or moderate fluid resuscitation in acute pancreatitis. New England Journal of Medicine, 387(11), 989-1000. https://doi.org/10.1056/nejmoa2202884.en
dc.identifier.doi10.1056/nejmoa2202884
dc.identifier.issn0028-4793
dc.identifier.urihttps://academica-e.unavarra.es/handle/2454/48332
dc.language.isoengen
dc.publisherMassachusetts Medical Societyen
dc.relation.ispartofNew England Journal of Medicine 2022, 387(11), 989-1000en
dc.relation.projectIDinfo:eu-repo/grantAgreement/ISCIII/Plan Estatal de Investigación Científica y Técnica y de Innovación 2017-2020 (ISCIII)/PI19%2F01628/ES/
dc.relation.publisherversionhttps://doi.org/10.1056/nejmoa2202884
dc.rights© 2022 Massachusetts Medical Society. All rights reserved.en
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess
dc.subjectFluid resuscitationen
dc.subjectAcute pancreatitisen
dc.titleAggressive or moderate fluid resuscitation in acute pancreatitisen
dc.typeinfo:eu-repo/semantics/article
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dspace.entity.typePublication
relation.isAuthorOfPublication1e8f0a28-8694-4f56-9319-f094dd6d28ff
relation.isAuthorOfPublication.latestForDiscovery1e8f0a28-8694-4f56-9319-f094dd6d28ff

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