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001-es BibID:	BIBFORM070012
035-os BibID:	e015874
Első szerző:	Márta Katalin
Cím:	High versus low energy administration in the early phase of acute pancreatitis (GOULASH trial) : protocol of a multicentre randomized double-blind clinical trial / Katalin Márta, Anikó Nóra Szabó, Dániel Pécsi, Péter Varjú, Judit Bajor, Szilárd Gódi, Patrícia Sarlós, Alexandra Mikó, Katalin Szemes, Mária Papp, Tamás Tornai, Áron Vincze, Zsolt Márton, Patrícia Anna Vincze, Erzsébet Lankó, Andrea Szentesi, Tímea Molnár, Roland Hagendorn, Faluhelyi Nándor, István Battyáni, Dezső Kelemen, Róbert Papp, Attila Miseta, Verzár Zsófia, Markus M. Lerch, Johan P. Neoptoleomos, Miklós Sain-Tóth, Ole H. Petersen, Peter Hegyi
Dátum:	2017
ISSN:	2044-6055
Megjegyzések:	Introduction. Acute pancreatitis (AP) is an inflammatory disease with no specific therapy. Mitochondrial injury followed by ATP depletion in both acinar and ductal cells is a recently discovered early event in the pathogenesis. Importantly, preclinical research showed that intracellular ATP delivery restores the physiological function of the cells and protects from cell injury suggesting that restoration of energy levels in the pancreas is therapeutically beneficial. Despite several, high quality and experimental observations in this area, no randomized trials have been conducted to date to address the requirements for energy intake in the early phase of AP. Methods/Design. This is a randomized, controlled two-arms double-blind multicentre trial. Patients suffering from AP will be randomly assigned to groups A (30 kcal/kg/day energy administration starting within 24h of hospital admission) or B (low energy administration during the first 72h of hospital admission). Energy will be delivered with nasoenteric tube feeding with additional intravenous glucose supplementation or total parenteral nutrition if necessary. A combination of multi organ failure for more than 48h and mortality is defined as the primary endpoint, whereas several secondary endpoints such as length of hospitalization or pain will be determined to elucidate more detailed differences between the groups. The general feasibility, safety and quality checks required for high quality evidence will be adhered to.Ethics and Dissemination. The study has been approved by the relevant organization, The Scientific and Research Ethics Committee of the Hungarian Medical Research Council (55961- 2/2016/EKU). This study will provide evidence whether early high-energy nutritional support is beneficial in the clinical management of AP. The results of this trial will be published in an open access way and disseminated among medical doctors.Trial registration: The trial has been registered at the ISRCTN (ISRTCN 63827758).
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban acute pancreatitis energy administration enteral feeding randomized clinical trial
Megjelenés:	BMJ Open. - 7 : 9 (2017), p. 1-9. -
További szerzők:	Szabó Anikó Nóra Pécsi Dániel Varjú Péter Bajor Judit Gódi Szilárd Sarlós Patrícia Mikó Alexandra Szemes Katalin Papp Mária (1975-) (belgyógyász, gasztroenterológus) Tornai Tamás István (1984-) (belgyógyász) Vincze Áron Márton Zsolt Vincze Patrícia Anna Lankó Erzsébet Szentesi Andrea Molnár Tímea Hágendorn Roland Faluhelyi Nándor Battyáni István Kelemen Dezső Papp Róbert Miseta Attila Verzár Zsófia Lerch, Markus M. Neoptoleomos, Johan P. Sain-Tóth, Miklós Petersen, Ole H. Hegyi Péter Jenő (belgyógyász)
Pályázati támogatás:	GINOP-2.3.2-15-2016-00015 GINOP KH-125678 NKFI
Internet cím:	Intézményi repozitóriumban (DEA) tárolt változat DOI
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