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Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis
Enrique de-Madaria1, James L Buxbaum1, Patrick Maisonneuve1
1From the Departments of Gastroenterology (E.M., L.G., A.V.-R.) and Clinical Pharmacology (P.Z.), Dr. Balmis General University Hospital, ISABIAL (Instituto de Investigación Sanitaria y Biomédica de Alicante), Alicante, the Department of Clinical Medicine, Faculty of Medicine, Miguel Hernández University, Elche (E.M.), the Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Universidad de Alcalá (A.G.G.P., M.Á.R.-G., J.D.-O.), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (P.Z., F.C.-S.), and the Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (F.C.-S.), Madrid, the Gastroenterology and Digestive Endoscopy Unit, Corporació Sanitària Parc Taulí, Sabadell (A.L.-A., L.P.L.), the Department of Gastroenterology, Hospital Clínico Universitario de Valencia, Valencia (P.N., A.M.S.-P.), the Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, Santander (C.S.-M., M.C.), the Department of Gastroenterology, Hospital Dr. Negrín, Las Palmas (I.F.-C.), the Department of Gastroenterology, Miguel Servet University Hospital and Health Research Institute of Aragón, Zaragoza (D.C.D.), the Department of Gastroenterology, Central de Asturias University Hospital, Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo (E.L.-B.), the Department of Gastroenterology, Lucus Augusti University Hospital, Lugo (E.M.-M.), the Department of Gastroenterology, Puerta del Mar University Hospital, Cadiz (L.M.C.-M.), and the Department of Gastroenterology, University Hospital of Navarre, Pamplona (V.U., M.G., F.B.) - all in Spain; the Division of Gastroenterology, University of Southern California, Los Angeles (J.L.B.); the Division of Epidemiology and Biostatistics, IRCSS European Institute of Oncology, Milan (P.M.); the General Surgery Unit, Department of Diseases of the Digestive Tract, Regional Hospital of High Specialty of Bajío, Leon, Mexico (E.E.L.-H., A.J.R.C.M.); and the Department of Gastroenterology, Surat Institute of Digestive Sciences Hospital and Research Center, Surat, India (R.M., R.T.).
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. (Funded by Instituto de Salud Carlos III and others; WATERFALL ClinicalTrials.gov number, NCT04381169.).
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