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Aggressive serotherapy impairs the health of patients with acute pancreatitis

The results of the Waterfall clinical trial: “Aggressive or moderate fluid therapy in acute pancreatitis”, a scientific article published in ‘The New England Journal of Medicine’, confirm that the treatment of acute pancreatitis with an abundance of serum in the first hours and days is detrimental to the patients’ prognosis

Aggressive serotherapy impairs the health of patients with acute pancreatitis

(Left-right). Lucía Guilabert (resident digestive system), Enrique de Madaria, Pedro Zapater (clinical pharmacologist, statistical advisor) and Alicia Vaillo (trial coordinator). EFE/Photo provided

“It is a serious danger for these people, hospitalized urgently for a moderate or serious crisis of the disease”, underlines, in statements to EFEsalut, Dr. Enric de Madaria Pascual, head of Pancreatology at the Health and Biomedical Research Institute of Alicante (ISABIAL), body that has led the international study.

“The clinical practice established in the hospital routine that it is necessary to put many drippers – intravenous serum with Ringer’s solution – because it improves the course of the disease and decreases complications, thus obtaining an improvement, is not true”, he explains.

“On the contrary, the circulatory system is recharged and evolution does not improve; the patients even get worse”, he counters.

The Waterfall study has shown that this clinical treatment is associated with a 20.5% increase in cardiopulmonary complications in patients with acute pancreatitis, who experience more respiratory distress, lung collapse, or heart failure due to fluid overload in the cardiovascular system .

“In contrast, a moderate treatment with these fluids is associated with only 6.3% of cases of cardiovascular overload and respiratory complications,” he notes.

De Madaria Pascual, specialist in the Digestive System Service of the Doctor Balmis General University Hospital in Alicante (which includes ISABIAL), as well as president of the Spanish Society of Gastroenterology, advises, accordingly, “abandon this clinical practice as soon as possible” which uses the abundance of intravenous serum therapy.

The treatment of acute pancreatitis (AP), moderate or severe

Pancreatitis is an inflammation of the pancreas, an elongated, flat gland located behind the stomach, in the upper abdomen. This pathology can appear in the acute form, expressing itself suddenly and for a few days, or in the more serious and chronic form lasting for years.

It is characterized by the appearance of vomiting and intense abdominal pain which in two out of three cases are mild, but in the rest they may suffer complications that affect the pancreas itself or other organs, such as the kidney or the lung.

“We have been studying serotherapy in acute pancreatitis for more than 10 years and this research means, finally, definitively clarifying the role of this aggressive treatment in patients admitted to a hospital”, emphasizes Dr. De Madaria, principal researcher of the study .

During the clinical trial, with 249 volunteer participants from eighteen health centers in Spain, India, Italy, and Mexico, both amounts of intravenous serum, copious or moderate, were provided, resulting in aggressive serotherapy generated 20.5% of complications compared to only 6.3% in cases of moderate.

Pancreatitis: Doctor Enric De MadariaEnrique De Madaria concludes that this “ambitious” study forces changes worldwide in the management of acute pancreatitis, the third disease of the digestive system in terms of revenue and that “is part of the day-to-day life of any hospital”.

Waterfall has been financed with the help of the Ministry of Science and Innovation through the Strategic Health Action of the Charles III Health Institute, together with contributions from ISABIAL (one of the centers accredited by the ISCIII) and the Spanish Association of Gastroenterology (AEG).

This randomized, controlled, multicenter clinical trial, which has lasted a year and a half, is the first original medical article published in the prestigious journal New England Journal Medicine (NEJM) promoted by a center in the province of Alicante and is positioned as the eighth clinical trial in gastroenterology led by a Spanish center.

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