High versus low energy administration in the early phase of acute pancreatitis (GOULASH trial) protocol of a multicentre randomised double-blind clinical trial /

INTRODUCTION: Acute pancreatitis (AP) is an inflammatory disease with no specific treatment. Mitochondrial injury followed by ATP depletion in both acinar and ductal cells is a recently discovered early event in its pathogenesis. Importantly, preclinical research has shown that intracellular ATP del...

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Main Authors: Márta Katalin
Szabó Anikó Nóra
Pécsi Dániel
Varjú Péter
Bajor Judit
Gódi Szilárd
Sarlós Patrícia
Mikó Alexandra
Vincze Áron
Márton Zsolt
Szentesi Andrea Ildikó
Hágendorn Roland
Faluhelyi Nándor
Battyáni István
Kelemen Dezső
Papp Róbert
Miseta Attila János
Verzár Zsófia
Hegyi Péter
Format: Article
Published: 2017
Series:BMJ OPEN 7 No. 9
doi:10.1136/bmjopen-2017-015874

mtmt:3267063
Online Access:http://publicatio.bibl.u-szeged.hu/12817
Description
Summary:INTRODUCTION: Acute pancreatitis (AP) is an inflammatory disease with no specific treatment. Mitochondrial injury followed by ATP depletion in both acinar and ductal cells is a recently discovered early event in its pathogenesis. Importantly, preclinical research has shown 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 experimental observations in this area, no randomised trials have been conducted to date to address the requirements for energy intake in the early phase of AP. METHODS/DESIGN: This is a randomised controlled two-arm double-blind multicentre trial. Patients with AP will be randomly assigned to groups A (30 kcal/kg/day energy administration starting within 24 hours of hospital admission) or B (low energy administration during the first 72 hours of hospital admission). Energy will be delivered by nasoenteric tube feeding with additional intravenous glucose supplementation or total parenteral nutrition if necessary. A combination of multiorgan failure for more than 48 hours and mortality is defined as the primary endpoint, whereas several secondary endpoints such as length of hospitalisation 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 organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (55961-2/2016/EKU). This study will provide evidence as to 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).
Physical Description:Azonosító: e015874.-Terjedelem: 10 p.
ISSN:2044-6055