One-Hour Bundle Protocols for Surgical Sepsis and Septic Shock in Surgical Intensive Care Unit: Clinical Outcome Aspects in the Thai Context.

Background: Surgical sepsis is a syndrome occurring during the perioperative period with a high mortality rate. Since the one-hour bundle protocol was recommended to decrease sepsis-related morbidity and mortality in clinical practice, the protocol has been applied to surgical patients with sepsis and septic shock. However, clinical outcomes in these surgical patients remain unknown. Thus, this study aimed to compare survival outcomes in patients before and after the implementation of one-hour bundle care in clinical practice.
Methods: In this prospective cohort study, 401 surgical patients with sepsis were divided into two groups, with 195 patients undergoing the one-hour bundle from December 25, 2021, to March 31, 2024, and 206 patients undergoing usual care from January 1, 2018, to December 24, 2021, before the one-hour bundle protocol was implemented by the Surviving Sepsis Campaign (SSC). Demographic data, treatment processes, and clinical outcomes were recorded.
Results: After the one-hour bundle protocol was applied in surgical practice, the median survival time was significantly increased in surgical patients who underwent one-hour bundle care (95% confidence interval (CI): 12.32-19.68) (p= 0.016). Factors influencing the increase in the mortality rate were delays in fluid resuscitation of >2 hours, vasopressor initiation of >2 hours, and empirical antibiotics of >5 hours (p= 0.017, 0.028, and 0.008, respectively).
Conclusion: One-hour bundle care for surgical patients with sepsis resulted in an increased median survival time. Delays in fluid resuscitation (>2 hours), vasopressor initiation (>2 hours), and empirical antibiotics (>5 hours) were factors associated with mortality.
Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. The Ethics Committee of the Institutional Review Board of the Royal Thai Army Medical Department issued approval S068h/64. The Thai Clinical Trials Registry Committee approved the study under their opinion number TCTR20240509003 on May 9, 2024, and the Ethics Committee of the Institutional Review Board of the Royal Thai Army Medical Department approved this study on December 24, 2021. Research number S068h/64 followed the Council for International Organization of Medical Science (CIOMS) Guidelines 2012 and Good Clinical Practice of International Conference on Harmonization statement number IRBRTA 1861/2564. Since this is a prospective study with no specific intervention but only a review of medical records, inpatient department data, and other hospital clinical data that generated results in a specific manner, not allowing the identification of patients, written informed consent was obtained according to the Council for International Organizations of Medical Science (CIOMS) Guidelines 2012 and Good Clinical Practice of International Conference on Harmonization. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.
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