Targeted therapy using polymyxin B hemadsorption in patients with sepsis: a post-hoc analysis of the JSEPTIC-DIC study and the EUPHRATES trial.


Journal

Critical care (London, England)
ISSN: 1466-609X
Titre abrégé: Crit Care
Pays: England
ID NLM: 9801902

Informations de publication

Date de publication:
21 06 2023
Historique:
received: 30 03 2023
accepted: 15 06 2023
medline: 23 6 2023
pubmed: 22 6 2023
entrez: 21 6 2023
Statut: epublish

Résumé

Polymyxin B hemadsorption (PMX-HA) reduces blood endotoxin levels, but characteristics of patients with sepsis likely to benefit from PMX-HA are not well known. We sought to identify patient subgroups likely to benefit from PMX-HA. We retrospectively identified 1911 patients with sepsis from a retrospective observational study in Japan (the JSEPTIC-DIC study) and 286 patients with endotoxemic septic shock from a randomized controlled trial in North America that restricted patients to those with high endotoxin activity (the EUPHRATES trial). We applied the machine learning-based causal forest model to the JSEPTIC-DIC cohort to investigate heterogeneity in treatment effects of PMX-HA on 28-day survival after adjusting for potential confounders and ascertain the best criteria for PMX-HA use. The derived criteria for targeted therapy by PMX-HA were validated using the EUPHRATES trial cohort. The causal forest model revealed heterogeneity in treatment effects of PMX-HA. Since patients having higher treatment effects were more likely to have severe coagulopathy and hyperlactatemia, we identified the potential treatment targets of PMX-HA as patients with PT-INR > 1.4 or lactate > 3 mmol/L. In the EUPHRATES trial cohort, PMX-HA use on the targeted subpopulation (75% of all patients) was significantly associated with higher 28-day survival (PMX-HA vs. control, 68% vs. 52%; treatment effect of PMX-HA, + 16% [95% CI + 2.2% to + 30%], p = 0.02). Abnormal coagulation and hyperlactatemia in septic patients with high endotoxin activity appear to be helpful to identify patients who may benefit most from PMX-HA. Our findings will inform enrollment criteria for future interventional trials targeting patients with coagulopathy and hyperlactatemia.

Sections du résumé

BACKGROUND
Polymyxin B hemadsorption (PMX-HA) reduces blood endotoxin levels, but characteristics of patients with sepsis likely to benefit from PMX-HA are not well known. We sought to identify patient subgroups likely to benefit from PMX-HA.
METHODS
We retrospectively identified 1911 patients with sepsis from a retrospective observational study in Japan (the JSEPTIC-DIC study) and 286 patients with endotoxemic septic shock from a randomized controlled trial in North America that restricted patients to those with high endotoxin activity (the EUPHRATES trial). We applied the machine learning-based causal forest model to the JSEPTIC-DIC cohort to investigate heterogeneity in treatment effects of PMX-HA on 28-day survival after adjusting for potential confounders and ascertain the best criteria for PMX-HA use. The derived criteria for targeted therapy by PMX-HA were validated using the EUPHRATES trial cohort.
RESULTS
The causal forest model revealed heterogeneity in treatment effects of PMX-HA. Since patients having higher treatment effects were more likely to have severe coagulopathy and hyperlactatemia, we identified the potential treatment targets of PMX-HA as patients with PT-INR > 1.4 or lactate > 3 mmol/L. In the EUPHRATES trial cohort, PMX-HA use on the targeted subpopulation (75% of all patients) was significantly associated with higher 28-day survival (PMX-HA vs. control, 68% vs. 52%; treatment effect of PMX-HA, + 16% [95% CI + 2.2% to + 30%], p = 0.02).
CONCLUSIONS
Abnormal coagulation and hyperlactatemia in septic patients with high endotoxin activity appear to be helpful to identify patients who may benefit most from PMX-HA. Our findings will inform enrollment criteria for future interventional trials targeting patients with coagulopathy and hyperlactatemia.

Identifiants

pubmed: 37344804
doi: 10.1186/s13054-023-04533-3
pii: 10.1186/s13054-023-04533-3
pmc: PMC10286480
doi:

Substances chimiques

Polymyxin B J2VZ07J96K
Anti-Bacterial Agents 0
Endotoxins 0

Types de publication

Randomized Controlled Trial Observational Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

245

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Informations de copyright

© 2023. The Author(s).

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Auteurs

Itsuki Osawa (I)

Department of Emergency and Critical Care Medicine, The University of Tokyo Hospital, 7-3-1, Hongo, Bunkyo-Ku, Tokyo, 1130033, Japan.

Tadahiro Goto (T)

Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan.
TXP Medical Co. Ltd., Tokyo, Japan.

Daisuke Kudo (D)

Division of Emergency and Critical Care Medicine, Tohoku University Graduate School of Medicine, Miyagi, Japan.

Mineji Hayakawa (M)

Department of Emergency Medicine, Hokkaido University Hospital, Hokkaido, Japan.

Kazuma Yamakawa (K)

Department of Emergency and Critical Care Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.

Shigeki Kushimoto (S)

Division of Emergency and Critical Care Medicine, Tohoku University Graduate School of Medicine, Miyagi, Japan.

Debra M Foster (DM)

Spectral Medical, Toronto, ON, Canada.

John A Kellum (JA)

Spectral Medical, Toronto, ON, Canada.
Department of Critical Care Medicine, Center for Critical Care Nephrology, University of Pittsburgh, Pittsburgh, PA, USA.

Kent Doi (K)

Department of Emergency and Critical Care Medicine, The University of Tokyo Hospital, 7-3-1, Hongo, Bunkyo-Ku, Tokyo, 1130033, Japan. kentdoi@m.u-tokyo.ac.jp.

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