A study of risk analysis and prognosis models for the mortality of sepsis based on real-world data in China

Background The study aimed to explore the factors associated with the mortality of sepsis and to develop prognosis models for predicting outcomes based on real-world data in China. Methods: Data regarding sepsis patients’ medical records were extracted from the hospital information systems in four hospitals. The data included general information, laboratory tests, score systems, and supportive treatment for sepsis. In total, 507 medical records with complete data were available for data analysis. Multiple variable regression (MR) analysis used to explore associations, and to develop prognosis models Results The mortality of sepsis was 0.3124 in the total sample. A univariate analysis indicated 23 variables significantly associated with the mortality of sepsis (p <0.05 for all). The MLR analysis showed independent and significant variables of age, GCS, SOFA, shock, breath rate, TBIL, CHE, BUN, LAC, OI, HCO3-, IMV, and ALB (P <0.05 for all). Prognosis models have a high predictive performance (AUC = 0.885, 95% CI: 0.854–0.917 in model2). Conclusion: The study showed evidence of independent and significant factors associated with the mortality of sepsis, including age, GCS, SOFA, septic shock, breath rate, TBIL, CHE, BUN, LAC, OI, HCO3-, IMV, and ALB. Prognosis models with a high performance were developed. (Trial registration: [ClinicalTrials.gov][1] Identifier: NCTNCT03883061 retrospectively registered 19 Mar 2019.) ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT03883061 ### Funding Statement Grants from the Institutes of Integrative Medicine of Fudan University ([NCT03883061][2]); and China Postdoctoral Science Foundation funded project (2017M611461) ### 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: The study was approved by Ethics Committee of the first hospital affiliated to South China University, Hunan, China and performed in accordance with the Declaration of Helsinki. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.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 The datasets generated and/or analyzed during the current study are not publicly available due to private information but are available from the corresponding author on reasonable request. Dataset are from the study whose authors may be contacted at Center of Bioinformatics and Biostatistics, Institutes of Integrative Medicine, Fudan University. [1]: http://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03883061&atom=%2Fmedrxiv%2Fearly%2F2020%2F07%2F25%2F2020.07.19.20151738.atom