CytoSorbents Corporation (CTSO)

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CLINICAL TRIAL article
Front. Pediatr.
Sec. Pediatric Critical Care
Volume 11 - 2023 | doi: 10.3389/fped.2023.1259384
Impact of CytoSorb and CKRT on hemodynamics in pediatric patients with septic shock: the PedCyto study
study
Gabriella Bottari1, 2* Isabella Guzzo1, 3 Andrea Cappoli1, 3 Raffaella Labbadia1, 3 Salvatore Perdichizzi1, 2 Carmela Serpe1 Jacques Creteur4, 5 Corrado Cecchetti1, 2 Fabio Silvio Taccone4, 5
1Bambino Gesù Children's Hospital (IRCCS), Italy
2Pediatric Intensive Care Unit Children's Hospital Bambino Gesù, Italy
3Unit of Nephrology and Dialysis, Department of Specialized Pediatrics and Kidney Liver Transplantation, Bambino Gesù Children's Hospital (IRCCS), Italy
4Hôpital Erasme, Université libre de Bruxelles, Belgium
5Service de Soins Intensifs, Hôpital Erasme, Université Libre de Bruxelles, Belgium

Background: There is a lack of data to support the use of hemoadsorption in pediatric septic shock.The aim of our study was to assess the effectiveness and safety of Cytosorb therapy in this setting.Phase II interventional single arm pilot study in which 17 consecutive children admitted with septic shock who required continuous kidney replacement therapy (CKRT) and weighed ≥ 10 kg were included. A CytoSorb (CytoSorbents Inc, New Jersey, USA) hemoadsorption cartridge was added to the CKRT every 24 hours for a maximum of 96 hours. A control group of 13 children with septic shock treated with CKRT but not hemoadsorption at Children's Hospital Bambino Gesù and enrolled in the EuroAKId register was selected as an historical cohort. The primary outcome of the study was a reduction in vasopressor or inotrope dose of > 50% from baseline by the end of Cytosorb therapy. Secondary outcomes included hemodynamic and biological changes, changes in severity scores, and 28-day mortality.Results: There were significant decreases in the Vasoactive Inotropic Score (VIS) and the Pediatric Logistic Organ Dysfunction 2 (PELOD-2) score at 72 and 96 hours from the start of the Cytosorb therapy compared to baseline; the reductions were larger in the hemoadsorption group than in the control group (historical cohort). 28-day mortality was lower, although not significantly, in the hemoadsorption group when compared to the control group (5/17 [29%] vs. 8/13 [61%] OR 0.26 [95% CI 0.05-1.2]; p= 0.08).
Conclusions: CytoSorb therapy may have some benefits in pediatric patients with septic shock. Future larger randomized trials are needed in this setting.

Received: 15 Jul 2023; Accepted: 21 Aug 2023.
Copyright: © 2023 Bottari, Guzzo, Cappoli, Labbadia, Perdichizzi, Serpe, Creteur, Cecchetti and Taccone. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Dr. Gabriella Bottari, Bambino Gesù Children's Hospital (IRCCS), Rome, Italy

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https://www.frontiersin.org/articles/10.3389/fped.2023.1259384/abstract