Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial
<p>Abstract</p> <p>Background</p> <p>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 star...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2011-03-01
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| Series: | Trials |
| Online Access: | http://www.trialsjournal.com/content/12/1/73 |
| _version_ | 1811246109810491392 |
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| author | Schaapherder Alexander F van Ramshorst Bert Nieuwenhuijs Vincent B Manusama Eric R Karsten Thom M Jansen Jeroen M Houdijk Alexander P Heisterkamp Joos van Goor Harry van Geenen Erwin J Dejong Cornelis H Brink Menno A Bosscha Koop Bollen Thomas L Boermeester Marja A Besselink Marc G Ali Usama van Brunschot Sandra van Santvoort Hjalmar C Bakker Olaf J van der Schelling George P Spanier Marcel BM Tan Adriaan Vecht Juda Weusten Bas L Witteman Ben J Akkermans Louis M Gooszen Hein G |
| author_facet | Schaapherder Alexander F van Ramshorst Bert Nieuwenhuijs Vincent B Manusama Eric R Karsten Thom M Jansen Jeroen M Houdijk Alexander P Heisterkamp Joos van Goor Harry van Geenen Erwin J Dejong Cornelis H Brink Menno A Bosscha Koop Bollen Thomas L Boermeester Marja A Besselink Marc G Ali Usama van Brunschot Sandra van Santvoort Hjalmar C Bakker Olaf J van der Schelling George P Spanier Marcel BM Tan Adriaan Vecht Juda Weusten Bas L Witteman Ben J Akkermans Louis M Gooszen Hein G |
| author_sort | Schaapherder Alexander F |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial Registration</p> <p>ISRCTN: <a href="http://www.controlled-trials.com/ISRCTN18170985">ISRCTN18170985</a></p> |
| first_indexed | 2024-04-12T14:48:54Z |
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| id | doaj.art-4f69ecc3f4df436eaed420dc14b16e06 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T14:48:54Z |
| publishDate | 2011-03-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj.art-4f69ecc3f4df436eaed420dc14b16e062022-12-22T03:28:32ZengBMCTrials1745-62152011-03-011217310.1186/1745-6215-12-73Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trialSchaapherder Alexander Fvan Ramshorst BertNieuwenhuijs Vincent BManusama Eric RKarsten Thom MJansen Jeroen MHoudijk Alexander PHeisterkamp Joosvan Goor Harryvan Geenen Erwin JDejong Cornelis HBrink Menno ABosscha KoopBollen Thomas LBoermeester Marja ABesselink Marc GAli Usamavan Brunschot Sandravan Santvoort Hjalmar CBakker Olaf Jvan der Schelling George PSpanier Marcel BMTan AdriaanVecht JudaWeusten Bas LWitteman Ben JAkkermans Louis MGooszen Hein G<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial Registration</p> <p>ISRCTN: <a href="http://www.controlled-trials.com/ISRCTN18170985">ISRCTN18170985</a></p>http://www.trialsjournal.com/content/12/1/73 |
| spellingShingle | Schaapherder Alexander F van Ramshorst Bert Nieuwenhuijs Vincent B Manusama Eric R Karsten Thom M Jansen Jeroen M Houdijk Alexander P Heisterkamp Joos van Goor Harry van Geenen Erwin J Dejong Cornelis H Brink Menno A Bosscha Koop Bollen Thomas L Boermeester Marja A Besselink Marc G Ali Usama van Brunschot Sandra van Santvoort Hjalmar C Bakker Olaf J van der Schelling George P Spanier Marcel BM Tan Adriaan Vecht Juda Weusten Bas L Witteman Ben J Akkermans Louis M Gooszen Hein G Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial Trials |
| title | Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial |
| title_full | Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial |
| title_fullStr | Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial |
| title_full_unstemmed | Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial |
| title_short | Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial |
| title_sort | pancreatitis very early compared with normal start of enteral feeding python trial design and rationale of a randomised controlled multicenter trial |
| url | http://www.trialsjournal.com/content/12/1/73 |
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