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.
Humans
Amiodarone
/ therapeutic use
Cardiopulmonary Resuscitation
/ methods
Electric Countershock
Emergency Medical Services
Hospitals
Lidocaine
/ therapeutic use
Multicenter Studies as Topic
Out-of-Hospital Cardiac Arrest
/ drug therapy
Potassium Chloride
/ therapeutic use
Prospective Studies
Ventricular Fibrillation
Clinical Trials, Phase II as Topic
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2023
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
e0284429Informations 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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