N Engl J Med. 2022;387(11):989–1000
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, the authors 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/kg of body weight, followed by 3 ml/kg/h. Moderate fluid resuscitation consisted of a bolus of 10 ml/kg in patients with hypovolemia or no bolus in patients with normovolemia, followed by 1.5 ml/kg/h 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 [aRR] = 1.30; 95% confidence interval [CI]: 0.78–2.18; 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 (aRR = 2.85; 95% CI: 1.36–5.94; p = 0.004). The median duration of hospitalization was 6 (interquartile range [IQR], 4–8) days in the aggressive-resuscitation group and 5 (IQR, 3–7) days 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.