Propafenone versus amiodarone for supraventricular arrhythmias in septic shock: a randomised controlled trial

Purpose Acute onset supraventricular arrhythmias can contribute to haemodynamic compromise in septic shock. Both amiodarone and propafenone are available interventions, but their clinical effects have not yet been directly compared. Methods In this two-centre, prospective controlled parallel group d...

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Veröffentlicht in:Intensive care medicine 2023-11, Vol.49 (11), p.1283-1292
Hauptverfasser: Balik, Martin, Maly, Michal, Brozek, Tomas, Rulisek, Jan, Porizka, Michal, Sachl, Robert, Otahal, Michal, Brestovansky, Petr, Svobodova, Eva, Flaksa, Marek, Stach, Zdenek, Horejsek, Jan, Volny, Lukas, Jurisinova, Ivana, Novotny, Adam, Trachta, Pavel, Kunstyr, Jan, Kopecky, Petr, Tencer, Tomas, Pazout, Jaroslav, Belohlavek, Jan, Duska, Frantisek, Krajcova, Adela, Waldauf, Petr
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container_end_page 1292
container_issue 11
container_start_page 1283
container_title Intensive care medicine
container_volume 49
creator Balik, Martin
Maly, Michal
Brozek, Tomas
Rulisek, Jan
Porizka, Michal
Sachl, Robert
Otahal, Michal
Brestovansky, Petr
Svobodova, Eva
Flaksa, Marek
Stach, Zdenek
Horejsek, Jan
Volny, Lukas
Jurisinova, Ivana
Novotny, Adam
Trachta, Pavel
Kunstyr, Jan
Kopecky, Petr
Tencer, Tomas
Pazout, Jaroslav
Belohlavek, Jan
Duska, Frantisek
Krajcova, Adela
Waldauf, Petr
description Purpose Acute onset supraventricular arrhythmias can contribute to haemodynamic compromise in septic shock. Both amiodarone and propafenone are available interventions, but their clinical effects have not yet been directly compared. Methods In this two-centre, prospective controlled parallel group double blind trial we recruited 209 septic shock patients with new-onset arrhythmia and a left ventricular ejection fraction above 35%. The patients were randomised in a 1:1 ratio to receive either intravenous propafenone (70 mg bolus followed by 400–840 mg/24 h) or amiodarone (300 mg bolus followed by 600–1800 mg/24 h). The primary outcomes were the proportion of patients who had sinus rhythm 24 h after the start of the infusion, time to restoration of the first sinus rhythm and the proportion of patients with arrhythmia recurrence. Results Out of 209 randomized patients, 200 (96%) received the study drug. After 24 h, 77 (72.8%) and 71 (67.3%) were in sinus rhythm ( p  = 0.4), restored after a median of 3.7 h (95% CI 2.3–6.8) and 7.3 h (95% CI 5–11), p  = 0.02, with propafenone and amiodarone, respectively. The arrhythmia recurred in 54 (52%) patients treated with propafenone and in 80 (76%) with amiodarone, p 
doi_str_mv 10.1007/s00134-023-07208-3
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Both amiodarone and propafenone are available interventions, but their clinical effects have not yet been directly compared. Methods In this two-centre, prospective controlled parallel group double blind trial we recruited 209 septic shock patients with new-onset arrhythmia and a left ventricular ejection fraction above 35%. The patients were randomised in a 1:1 ratio to receive either intravenous propafenone (70 mg bolus followed by 400–840 mg/24 h) or amiodarone (300 mg bolus followed by 600–1800 mg/24 h). The primary outcomes were the proportion of patients who had sinus rhythm 24 h after the start of the infusion, time to restoration of the first sinus rhythm and the proportion of patients with arrhythmia recurrence. Results Out of 209 randomized patients, 200 (96%) received the study drug. After 24 h, 77 (72.8%) and 71 (67.3%) were in sinus rhythm ( p  = 0.4), restored after a median of 3.7 h (95% CI 2.3–6.8) and 7.3 h (95% CI 5–11), p  = 0.02, with propafenone and amiodarone, respectively. The arrhythmia recurred in 54 (52%) patients treated with propafenone and in 80 (76%) with amiodarone, p  &lt; 0.001. Patients with a dilated left atrium had better rhythm control with amiodarone (6.4 h (95% CI 3.5; 14.1) until cardioversion vs 18 h (95% CI 2.8; 24.7) in propafenone, p  = 0.05). Conclusion Propafenone does not provide better rhythm control at 24 h yet offers faster cardioversion with fewer arrhythmia recurrences than with amiodarone, especially in patients with a non-dilated left atrium. No differences between propafenone and amiodarone on the prespecified short- and long-term outcomes were observed.</description><identifier>ISSN: 0342-4642</identifier><identifier>EISSN: 1432-1238</identifier><identifier>DOI: 10.1007/s00134-023-07208-3</identifier><identifier>PMID: 37698594</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Amiodarone ; Amiodarone - therapeutic use ; Anesthesiology ; Anti-Arrhythmia Agents - therapeutic use ; Arrhythmia ; Atrial Fibrillation - therapy ; Cardiac arrhythmia ; Cardiac patients ; Cardioversion ; Critical Care Medicine ; Drug delivery systems ; Drug therapy ; Emergency Medicine ; Encainide hydrochloride ; Heart ; Hemodynamics ; Humans ; Intensive ; Medicine ; Medicine &amp; Public Health ; Original ; Pain Medicine ; Pediatrics ; Pneumology/Respiratory System ; Propafenone - therapeutic use ; Prospective Studies ; Rhythm ; Sepsis ; Septic shock ; Shock, Septic - complications ; Shock, Septic - drug therapy ; Sinuses ; Stroke Volume ; Ventricle ; Ventricular Function, Left</subject><ispartof>Intensive care medicine, 2023-11, Vol.49 (11), p.1283-1292</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2023. 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Springer-Verlag GmbH Germany, part of Springer Nature.</rights><rights>COPYRIGHT 2023 Springer</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c480t-e46c52b4cb907e6eb439c08ef3e43656b702a01733dda5b35c1139fd3e13786d3</citedby><cites>FETCH-LOGICAL-c480t-e46c52b4cb907e6eb439c08ef3e43656b702a01733dda5b35c1139fd3e13786d3</cites><orcidid>0000-0003-1864-2143</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00134-023-07208-3$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00134-023-07208-3$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37698594$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Balik, Martin</creatorcontrib><creatorcontrib>Maly, Michal</creatorcontrib><creatorcontrib>Brozek, Tomas</creatorcontrib><creatorcontrib>Rulisek, Jan</creatorcontrib><creatorcontrib>Porizka, Michal</creatorcontrib><creatorcontrib>Sachl, Robert</creatorcontrib><creatorcontrib>Otahal, Michal</creatorcontrib><creatorcontrib>Brestovansky, Petr</creatorcontrib><creatorcontrib>Svobodova, Eva</creatorcontrib><creatorcontrib>Flaksa, Marek</creatorcontrib><creatorcontrib>Stach, Zdenek</creatorcontrib><creatorcontrib>Horejsek, Jan</creatorcontrib><creatorcontrib>Volny, Lukas</creatorcontrib><creatorcontrib>Jurisinova, Ivana</creatorcontrib><creatorcontrib>Novotny, Adam</creatorcontrib><creatorcontrib>Trachta, Pavel</creatorcontrib><creatorcontrib>Kunstyr, Jan</creatorcontrib><creatorcontrib>Kopecky, Petr</creatorcontrib><creatorcontrib>Tencer, Tomas</creatorcontrib><creatorcontrib>Pazout, Jaroslav</creatorcontrib><creatorcontrib>Belohlavek, Jan</creatorcontrib><creatorcontrib>Duska, Frantisek</creatorcontrib><creatorcontrib>Krajcova, Adela</creatorcontrib><creatorcontrib>Waldauf, Petr</creatorcontrib><title>Propafenone versus amiodarone for supraventricular arrhythmias in septic shock: a randomised controlled trial</title><title>Intensive care medicine</title><addtitle>Intensive Care Med</addtitle><addtitle>Intensive Care Med</addtitle><description>Purpose Acute onset supraventricular arrhythmias can contribute to haemodynamic compromise in septic shock. Both amiodarone and propafenone are available interventions, but their clinical effects have not yet been directly compared. Methods In this two-centre, prospective controlled parallel group double blind trial we recruited 209 septic shock patients with new-onset arrhythmia and a left ventricular ejection fraction above 35%. The patients were randomised in a 1:1 ratio to receive either intravenous propafenone (70 mg bolus followed by 400–840 mg/24 h) or amiodarone (300 mg bolus followed by 600–1800 mg/24 h). The primary outcomes were the proportion of patients who had sinus rhythm 24 h after the start of the infusion, time to restoration of the first sinus rhythm and the proportion of patients with arrhythmia recurrence. Results Out of 209 randomized patients, 200 (96%) received the study drug. After 24 h, 77 (72.8%) and 71 (67.3%) were in sinus rhythm ( p  = 0.4), restored after a median of 3.7 h (95% CI 2.3–6.8) and 7.3 h (95% CI 5–11), p  = 0.02, with propafenone and amiodarone, respectively. The arrhythmia recurred in 54 (52%) patients treated with propafenone and in 80 (76%) with amiodarone, p  &lt; 0.001. Patients with a dilated left atrium had better rhythm control with amiodarone (6.4 h (95% CI 3.5; 14.1) until cardioversion vs 18 h (95% CI 2.8; 24.7) in propafenone, p  = 0.05). Conclusion Propafenone does not provide better rhythm control at 24 h yet offers faster cardioversion with fewer arrhythmia recurrences than with amiodarone, especially in patients with a non-dilated left atrium. No differences between propafenone and amiodarone on the prespecified short- and long-term outcomes were observed.</description><subject>Amiodarone</subject><subject>Amiodarone - therapeutic use</subject><subject>Anesthesiology</subject><subject>Anti-Arrhythmia Agents - therapeutic use</subject><subject>Arrhythmia</subject><subject>Atrial Fibrillation - therapy</subject><subject>Cardiac arrhythmia</subject><subject>Cardiac patients</subject><subject>Cardioversion</subject><subject>Critical Care Medicine</subject><subject>Drug delivery systems</subject><subject>Drug therapy</subject><subject>Emergency Medicine</subject><subject>Encainide hydrochloride</subject><subject>Heart</subject><subject>Hemodynamics</subject><subject>Humans</subject><subject>Intensive</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Original</subject><subject>Pain Medicine</subject><subject>Pediatrics</subject><subject>Pneumology/Respiratory System</subject><subject>Propafenone - therapeutic use</subject><subject>Prospective Studies</subject><subject>Rhythm</subject><subject>Sepsis</subject><subject>Septic shock</subject><subject>Shock, Septic - complications</subject><subject>Shock, Septic - drug therapy</subject><subject>Sinuses</subject><subject>Stroke Volume</subject><subject>Ventricle</subject><subject>Ventricular Function, Left</subject><issn>0342-4642</issn><issn>1432-1238</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kk1rFTEUhoMo9rb6B1xIwI2bqfmaJOOulPoBBV3oOmQyZ-5NzSRjMlPov2-ut1qUi2SRcPK8L-ccXoReUXJOCVHvCiGUi4Yw3hDFiG74E7ShgrOGMq6fog3hgjVCCnaCTku5qbiSLX2OTriSnW47sUHT15xmO0JMEfAt5LIWbCefBpv3lTFlXNY521uIS_ZuDTZjm_PubtlN3hbsIy4wL97hskvux3tscbZxSJMvMGCXqiqFUJ9VbcML9Gy0ocDLh_sMff9w9e3yU3P95ePny4vrxglNlgaEdC3rhes7okBCL3jniIaRg-Cylb0izNZhOB8G2_a8dZTybhw4UK60HPgZenvwnXP6uUJZTO3HQQg2QlqLYVoK2spOiYq--Qe9SWuOtbtK6ZZrphl5pLY2gPFxTEu2bm9qLpSiTOnaQaWaI9QWImQb6jpHX8t_8edH-HoGmLw7KmAHgcuplAyjmbOfbL4zlJh9JswhE6ZmwvzKhNmLXj9MuPYTDH8kv0NQAX4ASv2KW8iPK_iP7T1x1MDq</recordid><startdate>20231101</startdate><enddate>20231101</enddate><creator>Balik, Martin</creator><creator>Maly, Michal</creator><creator>Brozek, Tomas</creator><creator>Rulisek, Jan</creator><creator>Porizka, Michal</creator><creator>Sachl, Robert</creator><creator>Otahal, Michal</creator><creator>Brestovansky, Petr</creator><creator>Svobodova, Eva</creator><creator>Flaksa, Marek</creator><creator>Stach, Zdenek</creator><creator>Horejsek, Jan</creator><creator>Volny, Lukas</creator><creator>Jurisinova, Ivana</creator><creator>Novotny, Adam</creator><creator>Trachta, Pavel</creator><creator>Kunstyr, Jan</creator><creator>Kopecky, Petr</creator><creator>Tencer, Tomas</creator><creator>Pazout, Jaroslav</creator><creator>Belohlavek, Jan</creator><creator>Duska, Frantisek</creator><creator>Krajcova, Adela</creator><creator>Waldauf, Petr</creator><general>Springer Berlin Heidelberg</general><general>Springer</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7Z</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1864-2143</orcidid></search><sort><creationdate>20231101</creationdate><title>Propafenone versus amiodarone for supraventricular arrhythmias in septic shock: a randomised controlled trial</title><author>Balik, Martin ; Maly, Michal ; Brozek, Tomas ; Rulisek, Jan ; Porizka, Michal ; Sachl, Robert ; Otahal, Michal ; Brestovansky, Petr ; Svobodova, Eva ; Flaksa, Marek ; Stach, Zdenek ; Horejsek, Jan ; Volny, Lukas ; Jurisinova, Ivana ; Novotny, Adam ; Trachta, Pavel ; Kunstyr, Jan ; Kopecky, Petr ; Tencer, Tomas ; Pazout, Jaroslav ; Belohlavek, Jan ; Duska, Frantisek ; Krajcova, Adela ; Waldauf, Petr</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c480t-e46c52b4cb907e6eb439c08ef3e43656b702a01733dda5b35c1139fd3e13786d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Amiodarone</topic><topic>Amiodarone - therapeutic use</topic><topic>Anesthesiology</topic><topic>Anti-Arrhythmia Agents - therapeutic use</topic><topic>Arrhythmia</topic><topic>Atrial Fibrillation - therapy</topic><topic>Cardiac arrhythmia</topic><topic>Cardiac patients</topic><topic>Cardioversion</topic><topic>Critical Care Medicine</topic><topic>Drug delivery systems</topic><topic>Drug therapy</topic><topic>Emergency Medicine</topic><topic>Encainide hydrochloride</topic><topic>Heart</topic><topic>Hemodynamics</topic><topic>Humans</topic><topic>Intensive</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Original</topic><topic>Pain Medicine</topic><topic>Pediatrics</topic><topic>Pneumology/Respiratory System</topic><topic>Propafenone - therapeutic use</topic><topic>Prospective Studies</topic><topic>Rhythm</topic><topic>Sepsis</topic><topic>Septic shock</topic><topic>Shock, Septic - complications</topic><topic>Shock, Septic - drug therapy</topic><topic>Sinuses</topic><topic>Stroke Volume</topic><topic>Ventricle</topic><topic>Ventricular Function, Left</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Balik, Martin</creatorcontrib><creatorcontrib>Maly, Michal</creatorcontrib><creatorcontrib>Brozek, Tomas</creatorcontrib><creatorcontrib>Rulisek, Jan</creatorcontrib><creatorcontrib>Porizka, Michal</creatorcontrib><creatorcontrib>Sachl, Robert</creatorcontrib><creatorcontrib>Otahal, Michal</creatorcontrib><creatorcontrib>Brestovansky, Petr</creatorcontrib><creatorcontrib>Svobodova, Eva</creatorcontrib><creatorcontrib>Flaksa, Marek</creatorcontrib><creatorcontrib>Stach, Zdenek</creatorcontrib><creatorcontrib>Horejsek, Jan</creatorcontrib><creatorcontrib>Volny, Lukas</creatorcontrib><creatorcontrib>Jurisinova, Ivana</creatorcontrib><creatorcontrib>Novotny, Adam</creatorcontrib><creatorcontrib>Trachta, Pavel</creatorcontrib><creatorcontrib>Kunstyr, Jan</creatorcontrib><creatorcontrib>Kopecky, Petr</creatorcontrib><creatorcontrib>Tencer, Tomas</creatorcontrib><creatorcontrib>Pazout, Jaroslav</creatorcontrib><creatorcontrib>Belohlavek, Jan</creatorcontrib><creatorcontrib>Duska, Frantisek</creatorcontrib><creatorcontrib>Krajcova, Adela</creatorcontrib><creatorcontrib>Waldauf, Petr</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; 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Both amiodarone and propafenone are available interventions, but their clinical effects have not yet been directly compared. Methods In this two-centre, prospective controlled parallel group double blind trial we recruited 209 septic shock patients with new-onset arrhythmia and a left ventricular ejection fraction above 35%. The patients were randomised in a 1:1 ratio to receive either intravenous propafenone (70 mg bolus followed by 400–840 mg/24 h) or amiodarone (300 mg bolus followed by 600–1800 mg/24 h). The primary outcomes were the proportion of patients who had sinus rhythm 24 h after the start of the infusion, time to restoration of the first sinus rhythm and the proportion of patients with arrhythmia recurrence. Results Out of 209 randomized patients, 200 (96%) received the study drug. After 24 h, 77 (72.8%) and 71 (67.3%) were in sinus rhythm ( p  = 0.4), restored after a median of 3.7 h (95% CI 2.3–6.8) and 7.3 h (95% CI 5–11), p  = 0.02, with propafenone and amiodarone, respectively. The arrhythmia recurred in 54 (52%) patients treated with propafenone and in 80 (76%) with amiodarone, p  &lt; 0.001. Patients with a dilated left atrium had better rhythm control with amiodarone (6.4 h (95% CI 3.5; 14.1) until cardioversion vs 18 h (95% CI 2.8; 24.7) in propafenone, p  = 0.05). Conclusion Propafenone does not provide better rhythm control at 24 h yet offers faster cardioversion with fewer arrhythmia recurrences than with amiodarone, especially in patients with a non-dilated left atrium. No differences between propafenone and amiodarone on the prespecified short- and long-term outcomes were observed.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>37698594</pmid><doi>10.1007/s00134-023-07208-3</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-1864-2143</orcidid></addata></record>
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subjects Amiodarone
Amiodarone - therapeutic use
Anesthesiology
Anti-Arrhythmia Agents - therapeutic use
Arrhythmia
Atrial Fibrillation - therapy
Cardiac arrhythmia
Cardiac patients
Cardioversion
Critical Care Medicine
Drug delivery systems
Drug therapy
Emergency Medicine
Encainide hydrochloride
Heart
Hemodynamics
Humans
Intensive
Medicine
Medicine & Public Health
Original
Pain Medicine
Pediatrics
Pneumology/Respiratory System
Propafenone - therapeutic use
Prospective Studies
Rhythm
Sepsis
Septic shock
Shock, Septic - complications
Shock, Septic - drug therapy
Sinuses
Stroke Volume
Ventricle
Ventricular Function, Left
title Propafenone versus amiodarone for supraventricular arrhythmias in septic shock: a randomised controlled trial
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