Effectiveness of polymyxin B hemoperfusion for sepsis depends on the baseline SOFA score: a nationwide observational study

Abstract

Background Polymyxin B hemoperfusion (PMX) aims to treat septic shock by removing endotoxin from the patient’s blood. However, the relationship between the severity of the patient's organ damage and the survival benefit of PMX treatment is not clear. Methods We analyzed the efficacy of PMX on adult sepsis patients using the propensity score matching method and the Japanese Diagnosis Procedure Combination (DPC) national inpatient database from April 2018 to March 2020. We stratified the patients into five categories based on their baseline Sequential Organ Failure Assessment (SOFA) score and compared the mortality between PMX-treated and non-treated groups in each category. We also compared continuous hemodiafiltration (CHDF)-, ventilator- and noradrenaline-free days between the groups. Results Of 44,177 patients included in the study, 2191 received PMX. After 1:1 propensity score matching, we created matched cohorts of 2033 pairs. PMX significantly improved the survival of the patients in the SOFA score categories of 7–9 and 10–12. On the other hand, there was no significant difference in the survival rate in SOFA score categories of 0–6, 13–15, and 16–24. In analyzing organ support-free days, PMX was also beneficial in the 7–9 and 10–12 SOFA categories compared to other categories. Conclusion Analysis of a large-scale Japanese inpatient database found a significant association between PMX efficacy and baseline SOFA score. This result indicates higher efficacy in patients with medium SOFA scores in the range of 7–12. The result provides a promising hypothesis for selecting appropriate patients for PMX and should be validated in future RCTs.

Potential survival benefit and early recovery from organ dysfunction with polymyxin B hemoperfusion: perspectives from a real-world big data analysis and the supporting mechanisms of action

“…Thus, the lower mortality in the control group is attributed to the lack of benefit from PMX-HP treatment observed in this study. In contrast, the mortality rate of the control group in the ABDOMIX study was 19.5%, which is comparable to the mortality rate of 19.9% in patients with SOFA scores ranging from 7 to 9 as reported by Fujimori et al [ 12 ]. However, the ABDOMIX study did not demonstrate a survival benefit.…”

“…Since 2018, in the J-DPC data, patients diagnosed with sepsis have their Sequential Organ Failure Assessment (SOFA) score assessed during the first 48 h after diagnosis. Fujimori et al examined the association between SOFA score at the onset of sepsis and the efficacy of PMX-HP treatment using the J-DPC database between April 2018 and March 2020 [ 12 ]. During the study period, 74,879 patients met the inclusion criteria.…”

“…The SOFA score of the matched pairs from the JSEPTIC DIC study was approximately 11 in both groups. Considering the results of the J-DPC study by Fujimori et al [ 12 ], the severity of the patients enrolled in was hypothesized to be adequately sufficient to obtain a significantly improved clinical outcome in the PMX-HP-treated group. The outcomes of the J-DPC studies and other large-scale studies are summarized in Table 2 .…”

“…Data is represented as the comparison between PMX-HP-treated group and control group (PMX-HP versus control). Data from the reference [ 12 ] study refers to SOFA score range 10–12. Length of ICU/ER stay and/or hospital stay rate: Data is represented as median (IQR).…”

When should polymyxin B‐immobilized polystyrene column be introduced to improve COVID‐19 prognosis?

“…The COVID‐19 Clinical Practice Guide in Japan (6th Edition) [ 2 ] states that PMX‐DHP treatment should be considered in certain cases due to its suppression of excessive inflammatory reactions in the “early stage before multiple organ failure progresses.” Remarkably, PMX‐DHP improves prognosis in sepsis patients with sequential organ failure assessment (SOFA) scores of 7–9, 10–12. However, PMX‐DHP does not affect prognosis in sepsis patients with SOFA 0–6, 13–15, 16–24 [ 3 ]. Therefore, we believe that PMX‐DHP should be considered in patients with moderate disease II when oxygen demand appears (Figure 1 ).…”