September 15, 2022
Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis
What was the research question?
·In patients with acute pancreatitis, is aggressive fluid resuscitation safe and effective compared to moderatel-agressive fluid strategy?
How did they do it?
A multicenter, open-label, parallel-group, randomized, controlled, superiority trial was conducted at 18 centers in India, Italy, Mexico, and Spain.
A total of 249 patients with varying degree of acute pancreatitis were randomized to receive aggressive fluid resuscitation with 20 ml/kg in 2 hours followed by 3 ml/kg/hour (122 patients), or moderate fluid resuscitation with a bolus of 10 ml per kilogram in patients with hypovolemia or no bolus in patients with normovolemia, followed by 1.5 ml/kg/hour (127 patients). Fluid rates were adjusted based on the clinical status of the patients.
The primary outcome was moderately severe or severe pancreatitis developed during hospitalization, and the main safety outcome was fluid overload.
What did they find?
The trial was terminated for safety concerns in the treatment group.
The primary outcome was not significantly different in the aggressive-resuscitation group compared to the moderate-resuscitation group (22.1% vs 17.3, RR, 1.30; 95% confidence interval [CI], 0.78 to 2.18; P = 0.32).
Fluid overload was significantly higher in the aggressive-resuscitation group compared to the moderate-resuscitation group (20.5% vs 6.3%, RR, 2.85; 95% CI, 1.36 to 5.94, P = 0.004).
The median hospital length of stay in the aggressive-resuscitation group was 6 days (interquartile range, 4 to 8), whereas it was 5 days (interquartile range, 3 to 7) in the moderate-resuscitation group.
Are there any limitations?
The study was ended early due to safety concerns and inefficacy, and thus not enough patients were observed. To get an accurate measure of efficacy, a larger number of patients would be needed, though this exposes them to the risks associated with fluid overload.
Possibility of bias due to the open-label nature of the trial.
What does it mean?
The use of aggressive fluid resuscitation in the treatment of acute pancreatitis was found to be associated with a higher risk of volume overload, as well as an absence of the predicted benefit in disease-specific outcomes, when compared to moderate fluid resuscitation.
Moderate fluid resuscitation is advised in patients with acute pancreatitis