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).
- acute pancreatitis
- energy administration
- enteral feeding
- randomized clinical trial
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Contributors All authors were involved in the study design, edited the manuscript, read and approved the final manuscript. During the study KM, ANS, DP and PV are going to randomise the patients and ensure the blinding. AM, KS, JB, SG, MP, PS, ZV and TT are going to manage the treatment of the patients. ÁV will be responsible for the organisation, quality and timing of the endoscopic treatments, ZM and RH for the intensive care, NF and IB for the imaging and interventional radiology, DK and RP for the surgical treatment if needed. PAV and EL will prepare the nutritional solutions. MML, JPN, MST and OHP are members of ITAB. TM and AS will be members of SC. PH and KM drafted the manuscript.
Funding Centre costs (IT, biostatistics, trial organization, etc) are covered by the University of Pécs, Momentum Grant of the Hungarian Academy of Sciences (LP2014-10/2014); and Economic Development and Innovation Operative Programme Grant and Highly Cited Publication Grant of the National Research, Development and Innovation Office (GINOP-2.3.2-15-2016-00015, KH-125678). Since no additional treatment is necessary for the study, the general healthcare costs are covered by the National Healthcare System.
Competing interests None declared.
Patient consent Obtained.
Ethics approval The Scientific and Research Ethics Committee of the Medical Research Council, 55961-2/2016/EKU.
Provenance and peer review Not commissioned; externally peer reviewed.
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