Dosing of Extracorporeal Cytokine Removal In Septic Shock (DECRISS): protocol of a prospective, randomised, adaptive, multicentre clinical trial.

Cytokines Hemoperfusion Humans Multicenter Studies as Topic Prospective Studies Randomized Controlled Trials as Topic Research Design Shock, Septic / therapy
adult intensive & critical care clinical trials intensive & critical care

Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
26 08 2021
Historique:
entrez: 27 8 2021
pubmed: 28 8 2021
medline: 15 9 2021
Statut: epublish

Résumé

Sepsis and septic shock have mortality rates between 20% and 50%. In sepsis, the immune response becomes dysregulated, which leads to an imbalance between proinflammatory and anti-inflammatory mediators. When standard therapeutic measures fail to improve patients' condition, additional therapeutic alternatives are applied to reduce morbidity and mortality. One of the most recent alternatives is extracorporeal cytokine adsorption with a device called CytoSorb. This study aims to compare the efficacy of standard medical therapy and continuous extracorporeal cytokine removal with CytoSorb therapy in patients with early refractory septic shock. Furthermore, we compare the dosing of CytoSorb adsorber device changed every 12 or 24 hours. It is a prospective, randomised, controlled, open-label, international, multicentre, phase III study. Patients fulfilling the inclusion criteria will be randomly assigned to receive standard medical therapy (group A) or-in addition to standard treatment-CytoSorb therapy. CytoSorb treatment will be continuous and last for at least 24 hours, CytoSorb adsorber device will be changed every 12 (group B) or 24 hours (group C). Our primary outcome is shock reversal (no further need or a reduced (≤10% of the maximum dose) vasopressor requirement for 3 hours) and time to shock reversal (number of hours elapsed from the start of the treatment to shock reversal).Based on sample size calculation, 135 patients (1:1:1) will need to be enrolled in the study. A predefined interim analysis will be performed after reaching 50% of the planned sample size, therefore, the corrected level of significance (p value) will be 0.0294. Ethics approval was obtained from the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (OGYÉI/65049/2020). Results will be submitted for publication in a peer-reviewed journal. NCT04742764; Pre-results.

Identifiants

DOI: 10.1136/bmjopen-2021-050464 PMID: 34446497 PMC: PMC8395301
pubmed: 34446497
pii: bmjopen-2021-050464
doi: 10.1136/bmjopen-2021-050464
pmc: PMC8395301
doi:

Substances chimiques

Cytokines 0

Banques de données

ClinicalTrials.gov
['NCT04742764']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e050464

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: ZMo is one of the medical directors at CytoSorbents Europe.

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Auteurs

Anna Kanjo (A)

Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.
Heim Pál National Paediatric Institute, Budapest, Hungary.
Doctoral School of Clinical Medicine, University of Szeged, Szeged, Hungary.

Zsolt Molnar (Z)

Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.
Doctoral School of Clinical Medicine, University of Szeged, Szeged, Hungary.
Chair and Department of Anaesthesiology and Intensive Therapy and Pain Treatment, Poznan University for Medical Sciences, Poznan, Poland.
Department of Anaesthesiology and Intensive Therapy, Semmelweis University, Budapest, Hungary.
ORCID: 0000-0002-1468-4058

Noémi Zádori (N)

Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.
Department of Anaesthesiology and Intensive Care, Medical School, University of Pécs, Pécs, Hungary.

Noémi Gede (N)

Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.

Bálint Erőss (B)

Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary.
Centre for Translational Medicine, Semmelweis University, Budapest, Hungary.
Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary.

Lajos Szakó (L)

Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.
János Szentágothai Research Center, University of Pécs, Pécs, Hungary.

Tamás Kiss (T)

Department of Anaesthesiology and Intensive Care, Medical School, University of Pécs, Pécs, Hungary.

Zsolt Márton (Z)

1st Department of Medicine, Medical School, University of Pécs, Pécs, Hungary.

Manu L N G Malbrain (MLNG)

International Fluid Academy, Lovenjoel, Belgium.
Faculty of Engineering, Department of Electronics and Informatics, Vrije Universiteit Brussel (VUB), Brussels, Belgium.
Medical Department, CMO, AZ Jan Palfijn Hospital, Ghent, Belgium.
First Department of Anaesthesiology and Intensive Therapy, Medical University of Lublin, Lublin, Poland.

Konstanty Szuldrzynski (K)

Department of Anaesthesiology and Intensive Care, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.
Chair of Anatomy, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland.

Jakub Szrama (J)

Chair and Department of Anaesthesiology and Intensive Therapy and Pain Treatment, Poznan University for Medical Sciences, Poznan, Poland.

Krzysztof Kusza (K)

Chair and Department of Anaesthesiology and Intensive Therapy and Pain Treatment, Poznan University for Medical Sciences, Poznan, Poland.

Klaus Kogelmann (K)

Department of Anaesthesiology and Intensive Care Medicine, Klinikum Emden, Emden, Germany.

Péter Hegyi (P)

Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary hegyi2009@gmail.com.
Centre for Translational Medicine, Semmelweis University, Budapest, Hungary.
Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary.
ORCID: 0000-0003-0399-7259

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Classifications MeSH

questionsmedicales.fr › Facteurs biologiques › Protéines et peptides de signalisation intercellulaire › Cytokines › Dosing of Extracorporeal Cytokine Removal In...
questionsmedicales.fr › Procédures de chirurgie opératoire › Circulation extracorporelle › Hémoperfusion › Dosing of Extracorporeal Cytokine Removal In...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Dosing of Extracorporeal Cytokine Removal In...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études multicentriques comme sujet › Dosing of Extracorporeal Cytokine Removal In...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › Dosing of Extracorporeal Cytokine Removal In...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Dosing of Extracorporeal Cytokine Removal In...
questionsmedicales.fr › Disciplines des sciences naturelles › Science › Recherche › Plan de recherche › Dosing of Extracorporeal Cytokine Removal In...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Choc › Syndrome de réponse inflammatoire généralisée › Choc septique › Dosing of Extracorporeal Cytokine Removal In...