Author:
Bakker Olaf J,van Santvoort Hjalmar C,van Brunschot Sandra,Ahmed Ali Usama,Besselink Marc G,Boermeester Marja A,Bollen Thomas L,Bosscha Koop,Brink Menno A,Dejong Cornelis H,van Geenen Erwin J,van Goor Harry,Heisterkamp Joos,Houdijk Alexander P,Jansen Jeroen M,Karsten Thom M,Manusama Eric R,Nieuwenhuijs Vincent B,van Ramshorst Bert,Schaapherder Alexander F,van der Schelling George P,Spanier Marcel BM,Tan Adriaan,Vecht Juda,Weusten Bas L,Witteman Ben J,Akkermans Louis M,Gooszen Hein G,
Abstract
Abstract
Background
In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN) within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4 days after admission.
Methods/Design
The PYTHON trial is a randomised controlled, parallel-group, superiority multicenter trial. Patients with predicted severe acute pancreatitis (Imrie-score ≥ 3 or APACHE-II score ≥ 8 or CRP > 150 mg/L) will be randomised to EN within 24 hours or an oral diet and EN if necessary, after 72 hours after hospital admission.
During a 3-year period, 208 patients will be enrolled from 20 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of mortality or infections (bacteraemia, infected pancreatic or peripancreatic necrosis, pneumonia) during hospital stay or within 6 months following randomisation. Secondary endpoints include other major morbidity (e.g. new onset organ failure, need for intervention), intolerance of enteral feeding and total costs from a societal perspective.
Discussion
The PYTHON trial is designed to show that a very early (< 24 h) start of EN reduces the combined endpoint of mortality or infections as compared to the current practice of an oral diet and EN if necessary at around 72 hours after admission for predicted severe acute pancreatitis.
Trial Registration
ISRCTN: ISRCTN18170985
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Cited by
26 articles.
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