1. Compared to moderate fluid resuscitation, an aggressive regimen in acute pancreatitis patients did not result in improved clinical outcomes.
2. Aggressive fluid resuscitation was associated with a higher rate of fluid overload.
Evidence Rating Level: 2 (Good)
Study Rundown: Acute pancreatitis is a medical emergency, where development into moderate or severe disease occurs frequently and is associated with poor clinical outcomes. Based on previous studies demonstrating that hypoperfusion and hypovolemia are contributory factors to pancreatic necrosis, fluid resuscitation has been shown to improve outcomes and reduce the risk of progression. However, the evidence supporting aggressive resuscitation versus moderate resuscitation has been limited. The current study was a multicenter randomized controlled trial comparing two resuscitation regimens (moderate and aggressive fluid resuscitation) in patients presenting with acute pancreatitis. During the interim analysis, the differences in the incidence of moderately severe or severe pancreatitis and the length of hospitalization between the groups were not statistically significant. Nevertheless, aggressive resuscitation was associated with a higher rate of fluid overload. Accordingly, the study was halted early owing to increased harm without benefits in clinical outcomes. Despite its open-label design, this study provided evidence that aggressive resuscitation was not superior to moderate resuscitation in acute pancreatitis.
Click here to read the study in NEJM
In-Depth [randomized controlled trial]: The present study was a multicenter, open-label, parallel-group, randomized controlled, superiority trial to compare aggressive fluid resuscitation against moderate resuscitation in managing acute pancreatitis. Inclusion criteria included a presentation to the emergency department within 24 hours of pain onset and diagnosis within eight hours before enrollment. Exclusion criteria included heart failure, uncontrolled hypertension, moderately severe or severe acute pancreatitis at baseline, and life expectancy of less than one year. At interim analysis, 249 patients had been randomized 1:1 to receive aggressive or moderate goal-directed fluid resuscitation with lactated Ringer’s solution. Patients were assessed every 12 hours up until 72 hours and resuscitation was adjusted according to the patient’s volume status. Resuscitation was reduced or stopped if fluid overload developed or once the patient could tolerate oral feeding for eight hours. The primary efficacy outcome was progression to moderately severe or severe acute pancreatitis, based on the Revised Atlanta Classification. The primary safety outcome was the development of fluid overload as a complication of fluid resuscitation. Overall, 22.1% of patients receiving aggressive resuscitation and 17.3% of those receiving moderate resuscitation went on to develop moderately severe or severe pancreatitis (Adjusted Relative Risk [ADR], 1.30; 95% Confidence Interval [CI], 0.78 to 2.18; p=0.32). Conversely, significantly more patients in the aggressive-resuscitation group (20.5%) than those in the moderate-resuscitation group (6.3%) developed fluid overload (ADR, 2.85; 95% CI, 1.36 to 5.94; p=0.004). The duration of hospitalization was similar between the two regimens. Consequently, the trial was halted early due to a lack of benefits and a potential increase in harm. Although the study was limited by the open-label design, it demonstrated that aggressive fluid resuscitation was non-superior to a moderate approach in managing acute pancreatitis and carried a risk of volume overload.
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