Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial

Research output: Contribution to journalResearch articleContributedpeer-review


  • Thilo von Groote - (Author)
  • Melanie Meersch - (Author)
  • Stefano Romagnoli - (Author)
  • Marlies Ostermann - (Author)
  • Javier Ripollés-Melchor - (Author)
  • Antoine Guillaume Schneider - (Author)
  • Wim Vandenberghe - (Author)
  • Céline Monard - (Author)
  • Silvia De Rosa - (Author)
  • Lucia Cattin - (Author)
  • Tim Rahmel - (Author)
  • Michael Adamzik - (Author)
  • Diego Parise - (Author)
  • Angel Candela-Toha - (Author)
  • Jan Gerrit Haaker - (Author)
  • Ulrich Göbel - (Author)
  • Alice Bernard - (Author)
  • Nuttha Lumlertgul - (Author)
  • Paula Fernández-Valdes-Bango - (Author)
  • Irene Romero Bhathal - (Author)
  • A Suarez-de-la-Rica - (Author)
  • Jan Larmann - (Author)
  • Gianluca Villa - (Author)
  • Savino Spadaro - (Author)
  • Hinnerk Wulf - (Author)
  • Christian Arndt - , University of Marburg (Author)
  • Christian Putensen - (Author)
  • Raquel García-Álvarez - (Author)
  • Timo Brandenburger - (Author)
  • Antonio Siniscalchi - (Author)
  • Richard Ellerkmann - (Author)
  • Florian Espeter - (Author)
  • Christian Porschen - (Author)
  • Mahan Sadjadi - (Author)
  • Khaschayar Saadat-Gilani - (Author)
  • Raphael Weiss - (Author)
  • Joachim Gerss - (Author)
  • John Kellum - (Author)
  • Alexander Zarbock - (Author)
  • BigpAK-2 Investigators - (Author)


Introduction Previous studies demonstrated that the implementation of the Kidney Disease Improving Global Outcomes (KDIGO) guideline-based bundle, consisting of different supportive measures in patients at high risk for acute kidney injury (AKI), might reduce rate and severity of AKI after surgery. However, the effects of the care bundle in broader population of patients undergoing surgery require confirmation. Methods and analysis The BigpAK-2 trial is an international, randomised, controlled, multicentre trial. The trial aims to enrol 1302 patients undergoing major surgery who are subsequently admitted to the intensive care or high dependency unit and are at high-risk for postoperative AKI as identified by urinary biomarkers (tissue inhibitor of metalloproteinases 2∗insulin like growth factor binding protein 7 (TIMP-2)∗IGFBP7)). Eligible patients will be randomised to receive either standard of care (control) or a KDIGO-based AKI care bundle (intervention). The primary endpoint is the incidence of moderate or severe AKI (stage 2 or 3) within 72 hours after surgery, according to the KDIGO 2012 criteria. Secondary endpoints include adherence to the KDIGO care bundle, occurrence and severity of any stage of AKI, change in biomarker values during 12 hours after initial measurement of (TIMP-2)∗(IGFBP7), number of free days of mechanical ventilation and vasopressors, need for renal replacement therapy (RRT), duration of RRT, renal recovery, 30-day and 60-day mortality, intensive care unit length-of-stay and hospital length-of-stay and major adverse kidney events. An add-on study will investigate blood and urine samples from recruited patients for immunological functions and kidney damage. Ethics and dissemination The BigpAK-2 trial was approved by the Ethics Committee of the Medical Faculty of the University of Münster and subsequently by the corresponding Ethics Committee of the participating sites. A study amendment was approved subsequently. In the UK, the trial was adopted as an NIHR portfolio study. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research. Trial registration number NCT04647396.


Original languageEnglish
Article numbere070240
JournalBMJ open
Issue number3
Publication statusPublished - 2023
Externally publishedYes

External IDs

Scopus 85150967176


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