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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
- 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
- Subjects :
- medicine.medical_specialty
Time Factors
OVERGROWTH
Medicine (miscellaneous)
Enteral administration
Severity of Illness Index
PROPHYLAXIS
law.invention
DOUBLE-BLIND
Study Protocol
ACUTE NECROTIZING PANCREATITIS
Enteral Nutrition
Randomized controlled trial
law
BACTERIAL TRANSLOCATION
Internal medicine
Multicenter trial
Severity of illness
medicine
Clinical endpoint
Humans
Pharmacology (medical)
SMALL-BOWEL MOTILITY
METAANALYSIS
APACHE
Netherlands
lcsh:R5-920
business.industry
MORTALITY
Bacterial Infections
medicine.disease
Surgery
Parenteral nutrition
Treatment Outcome
Pancreatitis
Evaluation of complex medical interventions [NCEBP 2]
Research Design
Acute Disease
Acute pancreatitis
ARTIFICIAL NUTRITION
business
lcsh:Medicine (General)
ORGAN FAILURE
Subjects
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