Heidelberg Perioperative Deep Data Study (HeiPoDD): study protocol for a prospective cohort study for prediction of complications after high-risk non-cardiac surgery in a German university hospital

BMJ Open, vol. 15, pp. e098590

Abstract

INTRODUCTION: Perioperative adverse events increase morbidity and mortality. The rate and severity of complications and the risk for subsequent mortality are increased after high-risk procedures and in elevated-risk patients. Over the past decades, a multitude of prognostic studies identified perioperative risk factors at the population level. However, to allow for the advancement of precision surgery strategies, improved risk prediction on the individual patient level is warranted. Comprehensive, consecutive, multisource, structured, high-quality patient-related and procedure-related data sets, together with thorough follow-up and combined with state-of-the-art machine-learning analyses, are needed to facilitate precise prediction of perioperative complications. Therefore, we designed and currently conduct the Heidelberg Perioperative Deep Data study (HeiPoDD). Here, we report the rationale and design of the HeiPoDD study. METHODS AND ANALYSIS: HeiPoDD is a prospective, single-centre, exploratory cohort study aiming to build up a large-scale deep-data base and corresponding biomaterial collection. 1040 adult patients planned for elective high-risk, non-cardiac surgery for any indication at Heidelberg University Hospital, Germany will be included. The obtained study-specific data set includes clinical data, lab values, genome- and proteome analysis as well as plasma, serum and peripheral blood mononuclear cells (PBMC) collected before and at days 1, 3 and 7 postsurgery. Urine samples are collected before and at day 1 postsurgery. Structured follow-up for perioperative complications such as redo-surgery, length of intensive care stay or length of hospital stay is conducted at days 30, 90 and 1 year postsurgery and for disease progression and survival after 3 and 5 years postsurgery. All study data will be transferred to the HeiPoDD registry to allow merging with all available routine clinical data from the hospital information system including imaging studies as well as haemodynamic and respiratory biosignals. Biomaterials will be stored in the HeiPoDD biomaterial bank to allow further analyses. ETHICS AND DISSEMINATION: The trial protocol and amendments were approved by the ethics committee of the University of Heidelberg (S-758/2021). The protocol is registered with the German Clinical Trial Register (DRKS00024625). Participating patients' data will be recorded only in pseudonymised form. After completion of the study, data collected during the study will be kept on file for up to 30 years. Biomedical samples collected during the study and entered into the biobank will be held for the same amount of time. The findings will be disseminated in peer-reviewed academic journals.

Authors 25

1. Mona Jung-König

   Heidelberg University

   Affiliation as printed

   Department of Anesthesiology, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

2. Hans Thomas Hölzer

   Heidelberg University

   Affiliation as printed

   Department of Anesthesiology, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

3. Solveig Tenckhoff

   Heidelberg University

   Affiliation as printed

   The Study Center of the German Surgical Society, Heidelberg University, Heidelberg, Germany

4. Sachin Kumar Aachen Department of Anaesthesiology, Medical Faculty

   Heidelberg University · RWTH Aachen University

   Affiliation as printed

   Department of Anaesthesiology, Medical Faculty, RWTH Aachen University, Aachen, Germany

   Department of Anesthesiology, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

5. Melanie Etheredge Aachen Department of Anaesthesiology, Medical Faculty

   Heidelberg University · RWTH Aachen University

   Affiliation as printed

   Department of Anaesthesiology, Medical Faculty, RWTH Aachen University, Aachen, Germany

   Department of Anesthesiology, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

6. Dominik Schaack

   Heidelberg University

   Affiliation as printed

   Department of Anesthesiology, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

7. Tobias Hölle

   Heidelberg University

   Affiliation as printed

   Department of Anesthesiology, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

8. Laura Christine Schuster

   Heidelberg University

   Affiliation as printed

   Department of Anesthesiology, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

9. Christian Nußhag

   Heidelberg University

   Affiliation as printed

   Department of Nephrology, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

10. Mathias Rath

    Heidelberg University

    Affiliation as printed

    Department of Urology, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

11. Christian Uhl Aachen Department of Vascular Surgery Medical Faculty

    Heidelberg University · RWTH Aachen University

    Affiliation as printed

    Department of Vascular Surgery, Medical Faculty, RWTH Aachen University, Aachen, Germany

    Department of Vascular and Endovascular Surgery, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

12. Frank Pianka

    Heidelberg University

    Affiliation as printed

    Department of General, Visceral and Transplantation Surgery, Heidelberg University, Clinical Study Center, Heidelberg, Germany

    Department of General, Visceral and Transplantation Surgery, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

13. Christoph W. Michalski

    Heidelberg University

    Affiliation as printed

    Department of General, Visceral and Transplantation Surgery, Heidelberg University, Clinical Study Center, Heidelberg, Germany

14. Markus Hohenfellner

    Heidelberg University

    Affiliation as printed

    Department of Urology, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

15. Rawa Arif

    Heidelberg University

    Affiliation as printed

    Department of Cardiac Surgery, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

16. Matthias Karck

    Heidelberg University

    Affiliation as printed

    Department of Cardiac Surgery, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

17. Dittmar Böckler

    Heidelberg University

    Affiliation as printed

    Department of Vascular and Endovascular Surgery, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

18. Pascal Probst

    Heidelberg University · Spital Thurgau (Switzerland) · Kantonsspital Frauenfeld

    Affiliation as printed

    Department of General, Visceral and Transplantation Surgery, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

    Department of Surgery, Cantonal Hospital Thurgau, Frauenfeld, Switzerland

19. Markus K. Diener

    Heidelberg University · Nuremberg Hospital

    Affiliation as printed

    Department of General, Visceral and Thoracic Surgery, Klinikum Nuernberg, Germany

    Department of General, Visceral and Transplantation Surgery, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

20. Markus Alexander Weigand

    Heidelberg University

    Affiliation as printed

    Department of Anesthesiology, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

21. Martin Dugas

    Heidelberg University

    Affiliation as printed

    Heidelberg University, Medical Faculty Heidelberg, Institute of Medical Informatics, Heidelberg, Germany

22. Christian Niklas

    Heidelberg University

    Affiliation as printed

    Heidelberg University, Medical Faculty Heidelberg, Institute of Medical Informatics, Heidelberg, Germany

23. Manuel Feißt

    Heidelberg University

    Affiliation as printed

    Institute of Medical Biometry, Heidelberg University, Heidelberg, Germany

24. Rosa Klotz

    Heidelberg University

    Affiliation as printed

    Department of General, Visceral and Transplantation Surgery, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany

    The Study Center of the German Surgical Society, Heidelberg University, Heidelberg, Germany

25. Jan Larmann corresponding Aachen Department of Anaesthesiology, Medical Faculty

    Heidelberg University · RWTH Aachen University

    Affiliation as printed

    Department of Anaesthesiology, Medical Faculty, RWTH Aachen University, Aachen, Germany

    Department of Anesthesiology, Heidelberg University, Medical Faculty Heidelberg, Heidelberg, Germany