Efficacy and safety of 1C class antiarrhythmic agent (propafenone) for supraventricular arrhythmias in septic shock compared to amiodarone: protocol of a prospective randomised double-blind study.
Adolescent
Adult
Aged
Aged, 80 and over
Amiodarone
/ therapeutic use
Anti-Arrhythmia Agents
/ therapeutic use
Double-Blind Method
Female
Follow-Up Studies
Humans
Male
Middle Aged
Propafenone
/ therapeutic use
Prospective Studies
Shock, Septic
/ complications
Stroke Volume
/ drug effects
Tachycardia, Supraventricular
/ complications
Treatment Outcome
Ventricular Function, Left
/ drug effects
Young Adult
amiodarone
intensive care
propafenone
septic shock
supraventricular arrhythmia
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
03 09 2019
03 09 2019
Historique:
entrez:
5
9
2019
pubmed:
5
9
2019
medline:
25
9
2020
Statut:
epublish
Résumé
Supraventricular arrhythmias contribute to haemodynamic compromise in septic shock. A retrospective study generated the hypothesis that propafenone could be more effective than amiodarone in achieving and maintaining sinus rhythm (SR). Certain echocardiographic parameters may predict a successful cardioversion and help in the decision on rhythm or rate control strategy. The trial includes septic shock patients with new-onset arrhythmia, but without severe impairment of the left ventricular ejection fraction. After baseline echocardiography, the patient is randomised to receive a bolus and maintenance dose of either amiodarone or propafenone. The primary outcome is the proportion of patients that have achieved rhythm control at 24 hours after the start of the infusion. The secondary outcomes are the percentages of patients that needed rescue treatments (DC cardioversion or unblinding and crossover of the antiarrhythmics), the recurrence of arrhythmias, intensive care unit mortality, 28-day and 1-year mortality. In the posthoc analysis, we separately assess subgroups of patients with pulmonary hypertension and right ventricular dysfunction. In the exploratory part of the study, we assess whether the presence of a transmitral diastolic A wave and its higher velocity-time integral is predictive for the sustainability of mechanical SR and whether the indexed left atrial endsystolic volume is predictive of recurrent arrhythmia. Considering that the restoration of SR within 24 hours occurred in 74% of the amiodarone-treated patients and in 89% of the patients treated with propafenone, we plan to include 200 patients to have an 80% chance to demonstrate the superiority of propafenone at p=0.05. The trial is recruiting patients according to its second protocol version approved by the University Hospital Ethical Board on the 6 October 2017 (No. 1691/16S-IV). The results will be disseminated through peer reviewed publications and conference presentations. NCT03029169.
Identifiants
pubmed: 31481571
pii: bmjopen-2019-031678
doi: 10.1136/bmjopen-2019-031678
pmc: PMC6731952
doi:
Substances chimiques
Anti-Arrhythmia Agents
0
Propafenone
68IQX3T69U
Amiodarone
N3RQ532IUT
Banques de données
ClinicalTrials.gov
['NCT03029169']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e031678Informations de copyright
© Author(s) (or their employer(s)) 2019. 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: None declared.
Références
Intensive Care Med. 2000 Dec;26(12):1730-9
pubmed: 11271079
N Engl J Med. 2002 Dec 5;347(23):1825-33
pubmed: 12466506
N Engl J Med. 2002 Dec 5;347(23):1834-40
pubmed: 12466507
J Am Coll Cardiol. 2003 Jan 15;41(2):255-62
pubmed: 12535819
Crit Care Med. 2003 Apr;31(4):1250-6
pubmed: 12682500
Crit Care Med. 2005 Jan;33(1):128-34; discussion 245-6
pubmed: 15644659
Am J Cardiol. 2006 Jan 1;97(1):130-6
pubmed: 16377298
Crit Care. 2007;11(6):233
pubmed: 18036267
Wien Klin Wochenschr. 2008;120(15-16):493-8
pubmed: 18820854
N Engl J Med. 1991 Mar 21;324(12):781-8
pubmed: 1900101
Eur J Echocardiogr. 2009 Mar;10(2):165-93
pubmed: 19270053
Drug Saf. 2010 Jul 1;33(7):539-58
pubmed: 20553056
Europace. 2011 Feb;13(2):161-73
pubmed: 21138930
Eur J Echocardiogr. 2011 Mar;12(3):214-21
pubmed: 21149290
Wien Klin Wochenschr. 2012 Aug;124(15-16):552-6
pubmed: 22815003
Cardiol J. 2013;20(2):203-5
pubmed: 23558880
Crit Care. 2013 Jul 04;17(4):164
pubmed: 23826739
Crit Care Med. 2013 Sep;41(9):2162-8
pubmed: 23873274
Europace. 2014 Jan;16(1):6-14
pubmed: 24084680
JAMA. 2013 Oct 23;310(16):1683-91
pubmed: 24108526
Wien Klin Wochenschr. 2014 Apr;126(7-8):246-7
pubmed: 24343046
Crit Care Res Pract. 2014;2014:840615
pubmed: 24527212
N Engl J Med. 2014 Oct 16;371(16):1496-506
pubmed: 25272316
Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):335-41
pubmed: 25274966
Am J Cardiol. 2015 Feb 1;115(3):316-22
pubmed: 25491240
Crit Care. 2014 Dec 15;18(6):688
pubmed: 25498795
Cochrane Database Syst Rev. 2015 Mar 28;(3):CD005049
pubmed: 25820938
Europace. 2016 Apr;18(4):568-71
pubmed: 26056191
Chest. 2016 Jan;149(1):74-83
pubmed: 26270396
Crit Care Med. 2015 Nov;43(11):2354-9
pubmed: 26468695
JAMA. 2016 Feb 23;315(8):801-10
pubmed: 26903338
N Engl J Med. 2016 May 19;374(20):1911-21
pubmed: 27043047
Intensive Care Med. 2016 Oct;42(10):1610-1612
pubmed: 27349242
Intern Emerg Med. 2017 Sep;12(6):853-859
pubmed: 27384766
Am J Respir Crit Care Med. 2017 Jan 15;195(2):205-211
pubmed: 27467907
Eur Heart J. 2016 Oct 7;37(38):2893-2962
pubmed: 27567408
Crit Care. 2016 Nov 18;20(1):373
pubmed: 27855722
J Crit Care. 2017 Oct;41:16-23
pubmed: 28463737
Crit Care Med. 2017 Sep;45(9):1436-1442
pubmed: 28542029
J Clin Diagn Res. 2017 Apr;11(4):UD01-UD02
pubmed: 28571241
Anaesthesiol Intensive Ther. 2017;49(5):419-429
pubmed: 29151002
PLoS One. 2018 May 22;13(5):e0197352
pubmed: 29787592
Int J Cardiol. 2018 Sep 1;266:147-148
pubmed: 29887432
Intensive Care Med. 1997 May;23(5):553-60
pubmed: 9201528