A Spanish study confirms that aggressive fluid therapy in acute pancreatitis is harmful and does not prevent complications
The WATERFALL trial, led by the Alicante Institute for Health and Biomedical Research (ISABIAL) and funded by the Carlos III Health Institute (ISCIII), has been published in the prestigious journal The New England Journal of Medicine (NEJM), and its results may change the clinical management currently established for acute pancreatitis
Alicante (15.09.22). A study funded by the Carlos III Health Institute (ISCIII) and conducted at Dr. Balmis General University Hospital of Alicante through the Alicante Institute for Health and Biomedical Research (ISABIAL) has challenged the approach established to date in the management of acute pancreatitis, concluding that the use of aggressive intravenous fluid therapy after hospital admission is not recommended, does not prevent complications and may even be harmful to patients. The results have just been published in The New England Journal of Medicine (NEJM), the most prestigious journal in the field of clinical medicine.
Acute pancreatitis is an inflammation of the pancreas, a gland located in the upper part of the abdomen. The disease is one of the most frequent causes of hospital admission due to digestive system conditions, characterized by moderate or intense pain in the abdomen; almost three out of ten cases are severe, but only one third of patients develop complications that affect the pancreas itself or other organs such as the kidney or the lung.
Until recently, experts recommended the use of very aggressive intravenous fluid therapy, popularly known as “fluid flooding,” for patients with acute pancreatitis during the first hours after admission, as it was thought that providing intensive fluids improved blood flow to the pancreas and prevented complications. The WATERFALL clinical trial, promoted, designed and coordinated by ISABIAL, now demonstrates that this recommendation is not appropriate, which could change a practice that has generated clinical debate in the management of pancreatitis for decades.
The WATERFALL study was conducted in 18 healthcare centers in Spain, India, Italy and Mexico. The analysis of 249 patients with acute pancreatitis has made it possible to conclude that the use of aggressive intravenous fluid therapy during the first hours after admission increases the risk of cardiopulmonary complications.
Twenty‑one percent of patients required aggressive fluid therapy to be discontinued due to a sensation of choking, worsening of imaging‑based edema indicators, or appearance of fluid overload. In contrast, treatment with moderate fluids was associated with this complication in only 6% of cases. In any case, it is confirmed that aggressive fluid therapy does not prevent other complications, as had previously been claimed.
The publication of the WATERFALL trial in The New England Journal of Medicine is accompanied by an editorial stating that this study definitively resolves the question of how much fluid should be administered to these patients, and describes it as a “Landmark study,” one that changes clinical practice.
Enrique de Madaria, head of the Digestive Diseases Unit at Dr. Balmis General University Hospital, Associate Director of Research at ISABIAL, Associate Professor at Miguel Hernández University of Elche (UMH), President of the Spanish Association of Gastroenterology (AEG), and principal investigator of the study, explains the results: “We are very proud of the commitment of the 18 centers that have participated in WATERFALL. We have been studying fluid therapy in acute pancreatitis for more than ten years, and this research finally clarifies the role of aggressive fluid therapy, which should be avoided”.
The WATERFALL study has been funded through a grant from the Ministry of Science and Innovation under the Strategic Health Action (AES) of the Carlos III Health Institute (ISCIII), through ISABIAL—one of the institutes accredited by the ISCIII—and the Spanish Association of Gastroenterology (AEG). It represents the first original clinical research article published in NEJM promoted by a center in the province of Alicante, and the eighth Spanish clinical trial in gastroenterology promoted by a Spanish center.
- Article reference: De Madaria JI, Buxbaum JL, Maisonneuve P, García García E, Zapater P, Guilabert A, Vails‑Rocamora A, Rodríguez‑Gandía MA, de Lera‑Hernández A, Al‑Saeed A, Livraghi L, Plotnick M, Tandel A, Navarro M, Sánchez‑Pardo A, Sánchez‑Marín M, Cobreros I, Fernández‑Cabrera F, Casas‑Seone D, Casas D, Lui M, Rauch B, Martínez‑García F, Camacho‑Monthoño V, Ganza J, B. F. Boldo, and the ERICA Consortium. Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis. N Engl J Med 2022;387:989‑1000. doi:10.1056/NEJMoa2202884.