Design
Setting
Publication
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
Conclusions
En este ensayo aleatorizado que incluyó a pacientes con pancreatitis aguda, la reanimación con fluidos agresiva temprana dio lugar a una mayor incidencia de sobrecarga de fluidos sin mejoría de los resultados clínicos.
