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Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial

Authors :
Bakker, O.J.
Santvoort, H.C. van
Brunschot, S. van
Ali, U.A.
Besselink, M.G.
Boermeester, M.A.
Bollen, T.L.
Bosscha, K.
Brink, M.A.
Dejong, C.H.
Geenen, E.J. van
Goor, H. van
Heisterkamp, J.
Houdijk, A.P.
Jansen, J.M.
Karsten, T.M.
Manusama, E.R.
Nieuwenhuijs, V.B.
Ramshorst, B. van
Schaapherder, A.F.
Schelling, G.P. van der
Spanier, M.B.M.
Tan, A.
Vecht, J.
Weusten, B.L.
Witteman, B.J.
Akkermans, L.M.
Gooszen, H.G.
Dutch Pancreatitis Study Grp
Surgery
RS: NUTRIM - R2 - Gut-liver homeostasis
RS: MHeNs School for Mental Health and Neuroscience
Graduate School
AII - Amsterdam institute for Infection and Immunity
AGEM - Amsterdam Gastroenterology Endocrinology Metabolism
Other departments
Gastroenterology and hepatology
CCA - Innovative therapy
Faculteit der Geneeskunde
Source :
Trials, 12(1). BioMed Central Ltd, Trials, Trials, 12(1). BioMed Central, Trials, 12:73. BioMed Central, Trials, 12, Trials, Vol 12, Iss 1, p 73 (2011), TRIALS, 12:73. BMC, Bakker, O J, van Santvoort, H C, van Brunschot, S, Ali, U A, Besselink, M G, Boermeester, M A, Bollen, T L, Bosscha, K, Brink, M A, Dejong, C H, van Geenen, E M, van Goor, H, Heisterkamp, J, Houdijk, A P, Jansen, J M, Karsten, T M, Manusama, E R, Nieuwenhuijs, V B, van Ramshorst, B, Schaapherder, A F, van der Schelling, G P, Spanier, M B M, Tan, A, Vecht, J, Weusten, B L, Witteman, B J, Akkermans, L M & Gooszen, H G 2011, ' Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial ', Trials, vol. 12, 73 . https://doi.org/10.1186/1745-6215-12-73
Publication Year :
2011

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

Details

Language :
English
ISSN :
17456215
Volume :
12
Issue :
1
Database :
OpenAIRE
Journal :
Trials
Accession number :
edsair.doi.dedup.....2a0ad9e519479be04be02147575519f4
Full Text :
https://doi.org/10.1186/1745-6215-12-73