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03.10.2021 | Original

High dose coupled plasma filtration and adsorption in septic shock patients. Results of the COMPACT-2: a multicentre, adaptive, randomised clinical trial

verfasst von: Elena Garbero, Sergio Livigni, Fiorenza Ferrari, Stefano Finazzi, Martin Langer, Paolo Malacarne, Manlio Cosimo Claudio Meca, Sabino Mosca, Carlo Olivieri, Marco Pozzato, Carlotta Rossi, Mario Tavola, Marina Terzitta, Bruno Viaggi, Guido Bertolini, GiViTI

Erschienen in: Intensive Care Medicine | Ausgabe 11/2021

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Abstract

Purpose

This study aimed at evaluating the efficacy and safety of high-dose (> 0.2 L/kg of treated plasma per day) coupled plasma filtration-adsorption (CPFA) in treating patients with septic shock.

Methods

Multicentre, randomised, adaptive trial, performed in 12 Italian intensive care units (ICUs). Patients aged 14 or more, admitted to the ICU with septic shock, or had developed it during the stay were eligible. The final outcome was mortality at discharge from the last hospital at which the patient received care.

Results

Between May 2015, and October 2017, 115 patients were randomised. The first interim analysis revealed a number of early deaths, prompting an unplanned analysis. Last hospital mortality was non-significantly higher in the CPFA (55.6%) than in the control group (46.2%, p = 0.35). The 90-day survival curves diverged in favour of the controls early after randomisation and remained separated afterwards (p = 0.100). An unplanned analysis showed higher mortality in CPFA compared to controls among patients without severe renal failure (p = 0.025); a dose–response relationship was observed between treated plasma volume and mortality (p = 0.010).

Conclusion

The COMPACT-2 trial was stopped due to the possible harmful effect of CPFA in patients with septic shock. The harmful effect, if present, was particularly marked in the early phase of septic shock. Patients not requiring renal replacement therapy seemed most exposed to the possible harm, with evidence of a dose–response effect. Until the mechanisms behind these results are fully understood, the use of CPFA for the treatment of patients with septic shock is not recommended.

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Titel: High dose coupled plasma filtration and adsorption in septic shock patients. Results of the COMPACT-2: a multicentre, adaptive, randomised clinical trial
verfasst von: Elena Garbero
Sergio Livigni
Fiorenza Ferrari
Stefano Finazzi
Martin Langer
Paolo Malacarne
Manlio Cosimo Claudio Meca
Sabino Mosca
Carlo Olivieri
Marco Pozzato
Carlotta Rossi
Mario Tavola
Marina Terzitta
Bruno Viaggi
Guido Bertolini
GiViTI
Publikationsdatum: 03.10.2021
Verlag: Springer Berlin Heidelberg
Erschienen in: Intensive Care Medicine / Ausgabe 11/2021
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-021-06501-3

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High dose coupled plasma filtration and adsorption in septic shock patients. Results of the COMPACT-2: a multicentre, adaptive, randomised clinical trial