Evaluation of the effectiveness of potassium chloride in the management of out-of hospital cardiac arrest by refractory ventricular fibrillation: Study protocol of the POTACREH study.


Journal

PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081

Informations de publication

Date de publication:
2023
Historique:
received: 21 06 2022
accepted: 10 10 2022
medline: 14 4 2023
entrez: 12 4 2023
pubmed: 13 4 2023
Statut: epublish

Résumé

Out-of-hospital cardiac arrest (OHCA) has a poor prognosis, with an overall survival rate of about 5% at discharge. Shockable rhythm cardiac arrests (ventricular fibrillation (VF) and pulseless ventricular tachycardia (VT)) have a better prognosis. In case of shockable rhythm, treatment is based on defibrillation, and thereafter, in case of failure of 3 external electric shocks (EES), on direct intravenous administration of 300 mg amiodarone, or lidocaine when amiodarone is unavailable or inefficient. During surgical procedures under extracorporeal circulation, a high potassium cardioplegia solution is administered to interrupt cardiac activity and facilitate surgical procedure. By extension, direct intravenous administration of potassium chloride (KCl) has been shown to convert VF, resulting in return to a hemodynamically efficient organized heart rate within a few minutes. The aim of this study is to provide clinical evidence that direct intravenous injection of KCl, into a patient presenting with OHCA due to refractory VF although 3 EES, should interrupt this VF and then allow rapid restauration of an organized heart rhythm, and thus return of spontaneous circulation (ROSC). A multicenter, prospective, single group, phase 2 study will be conducted on 81 patients presenting with refractory VF. After failure of 3 EES, each patient will receive direct intravenous injection of 20 mmol KCl instead of amiodarone. The primary outcome will be survival rate at hospital admission. Major secondary outcomes will include ROSC and time to ROSC in the prehospital setting, number of VF recidivism after KCl injection, survival rate at hospital discharge with a good neurologic prognostic, and survival rate 3 months after hospital discharge with a good neurologic prognostic. No patient is currently included in the study. Conventional guideline strategy based on antiarrhythmic drug administration, i.e. amiodarone or lidocaine, for OHCA due to shockable rhythm, has not yet demonstrated an increase in survival at hospital admission or at hospital discharge. This may be related to the major cardiodepressant effect of those drugs. ClinicalTrials.gov Identifier: NCT04316611. Registered on March 2020. AP-HP180577 / N° EUDRACT: 2019-002544-24. Funded by the French Health Ministry. https://clinicaltrials.gov/ct2/show/NCT04316611.

Identifiants

pubmed: 37043520
doi: 10.1371/journal.pone.0284429
pii: PONE-D-22-11622
pmc: PMC10096226
doi:

Substances chimiques

Amiodarone N3RQ532IUT
Lidocaine 98PI200987
Potassium Chloride 660YQ98I10

Banques de données

ClinicalTrials.gov
['NCT04316611']
EudraCT
['2019-002544-24']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0284429

Informations de copyright

Copyright: © 2023 Jouffroy et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Déclaration de conflit d'intérêts

The authors have declared that no competing interests exist.

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Auteurs

Romain Jouffroy (R)

SAMU de Paris, Service d'Anesthésie-Réanimation, Hôpital Universitaire Necker-Enfants Malades, APHP Centre, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris, France.

Patrick Ecollan (P)

SMUR Pitié Salpêtrière, Groupe Hospitalier Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France.

Charlotte Chollet-Xemard (C)

SAMU du Val de Marne, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France.

Bertrand Prunet (B)

Brigade de Sapeurs-Pompiers de Paris, Paris, France.

Caroline Elie (C)

URC Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France.

Jean-Marc Treluyer (JM)

URC Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France.

Benoit Vivien (B)

SAMU de Paris, Service d'Anesthésie-Réanimation, Hôpital Universitaire Necker-Enfants Malades, APHP Centre, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris, France.

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Classifications MeSH