WATERFALL
Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis
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Overview
In acute pancreatitis, aggressive lactated Ringer's did not reduce moderately severe or severe disease and increased fluid overload versus moderate fluids.
Clinical takeaway
Do not use early aggressive fluid resuscitation in acute pancreatitis expecting less severe disease. Moderate, goal-directed lactated Ringer's caused less fluid overload.
Key result
Moderately severe or severe pancreatitis occurred in 22.1% with aggressive versus 17.3% with moderate resuscitation (adjusted RR 1.30, 95% CI 0.78-2.18; P=0.32).
Practice impact
Use moderate, not aggressive, goal-directed lactated Ringer's for early pancreatitis resuscitation.
Evidence
Study design
Randomized trial at 18 centers comparing goal-directed aggressive versus moderate resuscitation with lactated Ringer's solution. The trial was halted after a planned interim analysis.
Enrollment
249
Follow-up
During the hospitalization, with assessments at 12, 24, 48, and 72 hours.
Geography
Not listed
Clinical question
Does early aggressive goal-directed fluid resuscitation reduce moderately severe or severe pancreatitis compared with moderate resuscitation?
Population
- Patients who presented with acute pancreatitis. A total of 249 patients were included in the interim analysis; the planned sample size was 744.
Intervention
Aggressive resuscitation: lactated Ringer's bolus of 20 ml per kilogram, then 3 ml per kilogram per hour, adjusted to clinical status.
Comparator
Moderate resuscitation: lactated Ringer's bolus of 10 ml per kilogram if hypovolemic or no bolus if normovolemic, then 1.5 ml per kilogram per hour, adjusted to clinical status.
Primary outcome
Development of moderately severe or severe pancreatitis during the hospitalization.
Aggressive resuscitation did not significantly change the incidence of moderately severe or severe pancreatitis compared with moderate resuscitation. The confidence interval included no effect.
Adjusted relative risk / 1.3 / 95% CI 0.78-2.18 / p=0.32
Key results
- In the interim analysis of 249 patients, moderately severe or severe pancreatitis occurred in 22.1% with aggressive resuscitation versus 17.3% with moderate resuscitation (adjusted RR 1.30, 95% CI 0.78-2.18; P=0.32).
- The trial was halted because of between-group differences in safety outcomes without a significant difference in the primary outcome.
- Median hospital stay was 6 days (IQR 4-8) with aggressive resuscitation versus 5 days (IQR 3-7) with moderate resuscitation.
Harms
- Fluid overload, the main safety outcome, occurred in 20.5% with aggressive resuscitation versus 6.3% with moderate resuscitation (adjusted RR 2.85, 95% CI 1.36-5.94; P=0.004).
Clinical Use
Practice impact
- Start with moderate goal-directed lactated Ringer's in acute pancreatitis rather than an aggressive 20 ml/kg bolus and 3 ml/kg/hour infusion.
Applicability
- Most applicable to patients presenting with acute pancreatitis who can receive goal-directed lactated Ringer's with reassessment at 12 to 72 hours.
Limitations
- The trial stopped after 249 patients were included in the interim analysis, well short of the planned 744.
- Enrollment for the interim analysis is reported as 249; the abstract does not give a separate randomized N.
- The primary result is from an interim analysis after the trial was halted for safety.
Common misinterpretations
- This does not show that fluids are unnecessary; both arms received goal-directed lactated Ringer's.
- The primary outcome was not improved by aggressive fluids; do not cite WATERFALL as proof that aggressive resuscitation reduces severe pancreatitis.
Related evidence
Citation
de-Madaria E, Buxbaum JL, Maisonneuve P, et al. Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis. N Engl J Med. 2022;387(11):989-1000. doi:10.1056/NEJMoa2202884
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.
- PMID
- 36103415