{
  "abstract": "Background Acute pancreatitis (AP) is among the most common gastrointestinal diseases requiring hospitalisation, often with severe outcomes and no disease-specific therapy. Nutritional support has been proven to improve outcome, but little is known regarding optimal timing and composition.Objective This clinical trial aimed to compare high (30 kcal/kg/day, high energy (HE)) versus gradually increasing energy (0 increased to 30 kcal/kg/day over 4 days, low energy (LE)) strategies for enteral nutritional support in AP.Design This was a multicentric, double-blind, randomised clinical trial, enrolling patients with AP regardless of predicted severity (January 2017 to April 2023). The primary outcome was a combination of mortality and severe acute pancreatitis (Revised Atlanta Criteria); secondary outcomes included severity, rate of infection, organ failure and pain relapse. Interim analysis was planned after 50% enrolment. The Benjamini-Hochberg false discovery rate (FDR) method was used to correct p value for multiple testing.Results The trial was stopped early after enrolling 636 patients. Interim analysis showed that the primary outcome showed no difference between groups in the modified intention-to-treat (mITT) population (HE: 28/312, 9.0% vs LE: 18/307, 5.7%, p(uncorrected/corrected)=0.19/0.42). Secondary outcomes showed no difference in the mITT analysis. Without correction for multiplicity testing, results favoured a low gradual energy strategy in terms of organ failure (HE: 52/312, 16.7% vs LE: 28/307, 9.1%, p(uncorrected)=0.007) and pain relapse (80/312, 27.1% vs 54/307, 19.0% p(uncorrected)=0.03) but showed no differences between groups after correction for multiple testing (p=0.13 and p=0.23, respectively). It was determined that the superiority of the intervention would not be shown even with an increased sample size, and thus the trial was terminated based on a post hoc decision on ethics and futility.Conclusion Based on this early terminated trial, a high-energy strategy for early nutrition in pancreatitis does not decrease mortality/severity, but potentially increases organ failure and pain relapse rate.Trial registration number ISRCTN63827758.",
  "authors": [
    {
      "affiliations": [
        "Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary"
      ],
      "name": "Katalin Márta"
    },
    {
      "affiliations": [
        "Centre for Translational Medicine, Semmelweis University, Budapest, Hungary"
      ],
      "name": "Marie Anne Engh"
    },
    {
      "affiliations": [
        "Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary"
      ],
      "name": "Áron Vincze"
    },
    {
      "affiliations": [
        "Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary",
        "Centre for Translational Medicine, Semmelweis University, Budapest, Hungary",
        "Institute for Translational Medicine, Mediacal School, University of Pécs, Pécs, Hungary"
      ],
      "name": "Bálint Erőss"
    },
    {
      "affiliations": [
        "Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary",
        "Centre for Translational Medicine, Semmelweis University, Budapest, Hungary"
      ],
      "name": "Péter J Hegyi"
    },
    {
      "affiliations": [
        "Institute for Translational Medicine, Mediacal School, University of Pécs, Pécs, Hungary",
        "Department of Medical Genetics, Medical School, University of Pécs, Pécs, Hungary"
      ],
      "name": "Alexandra Mikó"
    },
    {
      "affiliations": [
        "Szent György Teaching Hospital of Fejér County, Székesfehérvár, Hungary"
      ],
      "name": "Ferenc Izbéki"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Institute of Internal Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary"
      ],
      "name": "Mária Papp"
    },
    {
      "affiliations": [
        "Institute for Translational Medicine, Mediacal School, University of Pécs, Pécs, Hungary"
      ],
      "name": "Péter Mátrai"
    },
    {
      "affiliations": [
        "Institute for Translational Medicine, Mediacal School, University of Pécs, Pécs, Hungary",
        "Department of Biostatistics, University of Veterinary Medicine, Budapest, Hungary"
      ],
      "name": "Zsolt Abonyi-Tóth"
    },
    {
      "affiliations": [
        "Department of Medical Imaging, Medical School, University of Pécs, Pécs, Hungary"
      ],
      "name": "Nándor Faluhelyi"
    },
    {
      "affiliations": [
        "Institute for Translational Medicine, Mediacal School, University of Pécs, Pécs, Hungary"
      ],
      "name": "Andrea Szentesi"
    },
    {
      "affiliations": [
        "Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary",
        "Centre for Translational Medicine, Semmelweis University, Budapest, Hungary",
        "Institute for Translational Medicine, Mediacal School, University of Pécs, Pécs, Hungary",
        "Translational Pancreatology Research Group, Interdisciplinary Centre for Excellence for Research, Development and Innovation, University of Szeged, Szeged, Hungary"
      ],
      "name": "Péter Hegyi"
    },
    {
      "affiliations": [],
      "name": "the Goulash Trial Group"
    }
  ],
  "title": "High versus gradually increasing energy nutrition in the early phase of acute pancreatitis (GOULASH): a multicentre double-blind randomised clinical trial",
  "uid": "1999ec36-f393-53ad-b08e-aa329c56537d"
}