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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.
BMJ Open 2019; 9(9):e031678BO

Abstract

INTRODUCTION

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.

METHODS AND ANALYSIS

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.

ETHICS AND DISSEMINATION

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.

TRIAL REGISTRATION NUMBER

NCT03029169.

Authors+Show Affiliations

Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU martin.balik@vfn.cz.Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University and Kralovske Vinohrady University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University and Kralovske Vinohrady University Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University and Kralovske Vinohrady University Hospital in Prague, Prague, Czech Republic, EU.2nd Department of Medicine, 1st Medical Faculty, Charles University and General Univeristy Hospital in Prague, Prague, Czech Republic, EU.Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31481571

Citation

Balik, Martin, et al. "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." BMJ Open, vol. 9, no. 9, 2019, pp. e031678.
Balik M, Waldauf P, Maly M, et al. 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. BMJ Open. 2019;9(9):e031678.
Balik, M., Waldauf, P., Maly, M., Matousek, V., Brozek, T., Rulisek, J., ... Stritesky, M. (2019). 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. BMJ Open, 9(9), pp. e031678. doi:10.1136/bmjopen-2019-031678.
Balik M, et al. 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. BMJ Open. 2019 Sep 3;9(9):e031678. PubMed PMID: 31481571.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Balik,Martin, AU - Waldauf,Petr, AU - Maly,Michal, AU - Matousek,Vojtech, AU - Brozek,Tomas, AU - Rulisek,Jan, AU - Porizka,Michal, AU - Sachl,Robert, AU - Otahal,Michal, AU - Brestovansky,Petr, AU - Svobodova,Eva, AU - Flaksa,Marek, AU - Stach,Zdenek, AU - Pazout,Jaroslav, AU - Duska,Frantisek, AU - Smid,Ondrej, AU - Stritesky,Martin, Y1 - 2019/09/03/ PY - 2019/9/5/entrez PY - 2019/9/5/pubmed PY - 2019/9/5/medline KW - amiodarone KW - intensive care KW - propafenone KW - septic shock KW - supraventricular arrhythmia SP - e031678 EP - e031678 JF - BMJ open JO - BMJ Open VL - 9 IS - 9 N2 - INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT03029169. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/31481571/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 L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=31481571 DB - PRIME DP - Unbound Medicine ER -