Comparison of predication of Acute Kidney Injury after cardiac surgery by health care providers versus the biomarker [TIMP-2]*[IGFBP7] and scoring systems. Protocol for a prospective single center observational study (PREDICTAKI)

Introduction Acute kidney injury occurs in up to one third of patients after cardiac surgery and is an important contributor for adverse outcome. Previous research has demonstrated the benefit of a bundle of preventive measurements to reduce AKI in a subgroup of patients with high risk for AKI development. Urinary stress biomarkers [TIMP-2]*[IGFBP7] are used to identify these patients who are at risk for AKI. The trial aims to investigate the potential discrepancy between biomarker results and clinical estimation of occurrence of AKI on ICU in clinical practice. Methods and analysis We plan to include 100 adult patients after cardiac surgery with cardiopulmonary bypass in a prospective, single center clinical trial. After cardiac surgery, different type of healthcare professional in ICU will provide a prediction of AKI occurrence and severity in the next 48 hours by filling in a questionnaire just before and after [TIMP-2]*[IGFBP7] biomarker analysis. Primary, this trial investigates the potential discrepancy in AKI prediction between clinical estimation by healthcare providers, biomarker results, and previous described score systems. Secondly, the impact of knowledge of the biomarker result on the quality of prediction by healthcare providers will be evaluated. Ethics and dissemination This prospective, single center study has been approved by the medical ethical committee of the Ghent University Hospital (28th May 2019, trial registration number B670201939991). Informed consent was obtained for patients and healthcare providers. Summary strength and limitations ### Competing Interest Statement WV: non declared LV: non declared AZ: AZ received grants from Astute Medical, Baxter, Fresenius, and Astellas. He also received fees from Astute Medical, BioMerieux, Baxter, Fresenius, La Jolla Pharmaceuticals, and Astellas MM: Astute Medical, Baxter, FMC: lecture fees EH: AM Pharma: travel fee, Sopachem: speakers fee, Astute Medical: speakers fee, Alexion: speakers fee ### Funding Statement There was no financial support for this study. When patients are co-enrolled in the PrevAKI trial, Nephrocheck device and cartridges were provided by this study. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This prospective, single center study has been approved by the medical ethical committee of Ghent University Hospital (28th May 2019, B670201939991). Informed consent was obtained for patients and healthcare providers. Trial oversight will be performed by the Health, Innovation and Research institute of Ghent University Hospital (HIRUZ). All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Data is not public available, but can be provided on reasonable request