Early aggressive hydration is widely recommended for the management of acute pancreatitis, but evidence for this practice is limited.
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At 18 centers, we randomly assigned patients who presented with acute pancreatitis to receive aggressive or moderate targeted resuscitation with Ringer’s lactate 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 hypovolemic patients or no bolus in normovolaemic patients, 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 hospitalization. The primary safety outcome was fluid overload. The planned sample size was 744, with a first interim analysis planned after recruitment of 248 patients.
A total of 249 patients were included in the interim analysis. The trial was discontinued due to group differences in safety outcomes with no 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; adjusted relative risk, 1.30; 95% confidence interval [CI], 0.78 to 2.18; p=0.32). Fluid overload developed in 20.5% of 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 length 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.
In this randomized trial of patients with acute pancreatitis, early aggressive fluid resuscitation resulted in a higher incidence of fluid overload without improving clinical outcomes. (Funded by Instituto de Salud Carlos III and others; WATERFALL ClinicalTrials.gov number, NCT04381169.)