Supraventricular ArrhythmiaPhase 4PRASENCT03029169
Propafenone Versus Amiodarone in Septic Shock
A Phase 4 study testing Propafenone i.v. and Amiodarone i.v. in people with Supraventricular Arrhythmia and Septic Shock, run by Charles University, Czech Republic at 2 sites in Czechia.
Trial summary
Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom administered in intensive care due to a dose dependent toxicity published in case reports and unfavourable outcome reported in a few… Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Supraventricular Arrhythmia, Septic Shock
- What is being tested?
- Propafenone i.v. and Amiodarone i.v.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesCzechia
- Study dates
- 23 Oct 2017to 1 Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Septic shock with a new onset SV arrhythmia
- LV systolic function normal to moderately reduced according to echocardiography.
Who cannot join
- Severe LV systolic dysfunction
- More than 1st degree AV block
- High dose vasopressor therapy with continuous noradrenaline > 1.0 ug/kg.min
- Known intolerance to amiodarone or propafenone
- Absence of septic shock
- Chronic AF
- Dependence on pacemaker
- Status after MAZE procedure
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Dept. Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University
Prague, 100 34
Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
Prague, 128 08
About this study
Official title: Prospective Randomized Study of Efficacy and Safety of 1c Class Antiarrhythmic Agent (Propafenone) in Septic Shock
Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom administered in intensive care due to a dose dependent toxicity published in case reports and unfavourable outcome reported in a few prospective trials done on cardiology patients. The papers on 1c class antiarrhythmics do not take into consideration a complex haemodynamic assessment using echocardiography. The authors have recently presented a retrospective study on SV arrhythmias in septic shock patients demonstrating favourable effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.
Read the detailed description
Primary aim is to verify the conclusions of the retrospective study, i.e. efficacy and safety of propafenone, in a prospective blinded randomized trial performed in two large intensive care units. Secondary aims are to monitor the electromechanics of left atrium in patients with SV arrhythmias in septic shock.
- Conditions
- Supraventricular Arrhythmia, Septic Shock
- Being tested
- Propafenone i.v., Amiodarone i.v.
- Keywords
- Supraventricular Arrhythmia, Septic shock, Propafenone, Amiodarone, Intensive Care
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propafenone i.v.Drug
Also called Antiarrhythmic therapy
Treatment
Amiodarone i.v.Drug
Also called Antiarrhythmic therapy
Treatment
| Study group | Role | What they receive |
|---|---|---|
| Propafenone i.v. | Active comparator | Patients in septic shock with a new onset supraventricular arrhythmia are randomized either to arm treated with propafenone or with amiodarone. Both arms will have standard treatment, there are no limits to indicated electric cardioversion as part of treatment.
Intervention: Bolus of 35-70 mg intravenous propafenone followed by continuous infusion of 400-840 mg/24h. Receives: Drug: Propafenone i.v. |
| Amiodarone i.v. | Active comparator | Patients in septic shock with a new onset supraventricular arrhythmia are randomized either to arm treated with propafenone or with amiodarone. Both arms will have standard treatment, there are no limits to indicated electric cardioversion as part of treatment.
Intervention: Bolus of 150-300 mg of intravenous amiodarone followed by continuous infusion of 600-1800 mg/24h. Receives: Drug: Amiodarone i.v. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of propafenone
cardioversion rate
Measured: 1 year
ICU mortality of septic shock patients on propafenone for a SV arrhythmia
ICU mortality
Measured: 1 year
28-day mortality of septic shock patients on propafenone for a SV arrhythmia
28-day mortality
Measured: 2 years
12-month mortality of septic shock patients on propafenone for a SV arrhythmia
12-month mortality
Measured: 2 years
Secondary outcomes (2)
Electromechanics of left atrium
left atrial emptying
Measured: 1 year
Electromechanics of LA
isovolumic and ejection times
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start23 Oct 2017
- Primary completion4 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Supraventricular ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Balik, Charles University, Czech Republic
- Investigators
- Martin Balik, A/Prof, Principal investigator, Dept of Anaesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029169
- Sponsor's protocol ID
- 1691/16 S-IV
- Acronym
- PRASE
- Status last verified
- Aug 2022
- First submitted
- 7 Dec 2016
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balik M, Tencer T, Svobodova E, Otahal M, Jurisinova I, Kaspar V, Krajcova A, Duska F, Waldauf P. Propafenone is associated with fewer recurrences of supraventricular arrhythmias in mechanically ventilated patients with septic shock and right ventricular dysfunction. Front Cardiovasc Med. 2026 May 7;13:1807380. doi: 10.3389/fcvm.2026.1807380. eCollection 2026.
PubMed 42181642Balik M, Waldauf P, Maly M, Brozek T, Rulisek J, Porizka M, Sachl R, Otahal M, Brestovansky P, Svobodova E, Flaksa M, Stach Z, Horejsek J, Volny L, Jurisinova I, Novotny A, Trachta P, Kunstyr J, Kopecky P, Tencer T, Pazout J, Krajcova A, Duska F. Echocardiography predictors of sustained sinus rhythm after cardioversion of supraventricular arrhythmia in patients with septic shock. J Crit Care. 2024 Oct;83:154832. doi: 10.1016/j.jcrc.2024.154832. Epub 2024 May 17.
PubMed 38759581Waldauf P, Porizka M, Horejsek J, Otahal M, Svobodova E, Jurisinova I, Maly M, Brozek T, Rulisek J, Trachta P, Tencer T, Krajcova A, Duska F, Balik M. The outcomes of patients with septic shock treated with propafenone compared to amiodarone for supraventricular arrhythmias are related to end-systolic left atrial volume. Eur Heart J Acute Cardiovasc Care. 2024 May 28;13(5):414-422. doi: 10.1093/ehjacc/zuae023.
PubMed 38372622Balik M, Waldauf P, Maly M, Matousek V, Brozek T, Rulisek J, Porizka M, Sachl R, Otahal M, Brestovansky P, Svobodova E, Flaksa M, Stach Z, Pazout J, Duska F, Smid O, Stritesky M. 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. doi: 10.1136/bmjopen-2019-031678.
PubMed 31481571
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Efficacy and Safety of 1c Class Antiarrhythmic Agent (Propafenone) in Septic Shock
- ClinicalTrials.gov ID
- NCT03029169
- Acronym / sponsor ID
- PRASE / 1691/16 S-IV
- Conditions
- Supraventricular Arrhythmia, Septic Shock
- Keywords
- Supraventricular Arrhythmia, Septic shock, Propafenone, Amiodarone, Intensive Care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom administered in intensive care due to a dose dependent toxicity published in case reports and unfavourable outcome reported in a few prospective trials done on cardiology patients. The papers on 1c class antiarrhythmics do not take into consideration a complex haemodynamic assessment using echocardiography. The authors have recently presented a retrospective study on SV arrhythmias in septic shock patients demonstrating favourable effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.
Detailed description
Primary aim is to verify the conclusions of the retrospective study, i.e. efficacy and safety of propafenone, in a prospective blinded randomized trial performed in two large intensive care units. Secondary aims are to monitor the electromechanics of left atrium in patients with SV arrhythmias in septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propafenone i.v. | Active comparator | Drug: Propafenone i.v.Patients in septic shock with a new onset supraventricular arrhythmia are randomized either to arm treated with propafenone or with amiodarone. Both arms will have standard treatment, there are no limits to indicated electric cardioversion as part of treatment. Intervention: Bolus of 35-70 mg intravenous propafenone followed by continuous infusion of 400-840 mg/24h. |
| Amiodarone i.v. | Active comparator | Drug: Amiodarone i.v.Patients in septic shock with a new onset supraventricular arrhythmia are randomized either to arm treated with propafenone or with amiodarone. Both arms will have standard treatment, there are no limits to indicated electric cardioversion as part of treatment. Intervention: Bolus of 150-300 mg of intravenous amiodarone followed by continuous infusion of 600-1800 mg/24h. |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Septic shock with a new onset SV arrhythmia
- LV systolic function normal to moderately reduced according to echocardiography.
Key exclusion criteria (8 listed)
- Severe LV systolic dysfunction
- More than 1st degree AV block
- High dose vasopressor therapy with continuous noradrenaline > 1.0 ug/kg.min
- Known intolerance to amiodarone or propafenone
- Absence of septic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propafenone i.v.Also: Antiarrhythmic therapyTreatment | Drug | Propafenone i.v. |
| Amiodarone i.v.Also: Antiarrhythmic therapyTreatment | Drug | Amiodarone i.v. |
Primary outcome
Efficacy of propafenone
Time frame: 1 year
cardioversion rate
ICU mortality of septic shock patients on propafenone for a SV arrhythmia
Time frame: 1 year
ICU mortality
28-day mortality of septic shock patients on propafenone for a SV arrhythmia
Time frame: 2 years
28-day mortality
12-month mortality of septic shock patients on propafenone for a SV arrhythmia
Time frame: 2 years
12-month mortality
2 secondary outcomes
Electromechanics of left atrium
Time frame: 1 year
Electromechanics of LA
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Derived from this study: PubMed 42181642Balik M, Tencer T, Svobodova E, Otahal M, Jurisinova I, Kaspar V, Krajcova A, Duska F, Waldauf P. Propafenone is associated with fewer recurrences of supraventricular arrhythmias in mechanically ventilated patients with septic shock and right ventricular dysfunction. Front Cardiovasc Med. 2026 May 7;13:1807380. doi: 10.3389/fcvm.2026.1807380. eCollection 2026.
- Derived from this study: PubMed 38759581Balik M, Waldauf P, Maly M, Brozek T, Rulisek J, Porizka M, Sachl R, Otahal M, Brestovansky P, Svobodova E, Flaksa M, Stach Z, Horejsek J, Volny L, Jurisinova I, Novotny A, Trachta P, Kunstyr J, Kopecky P, Tencer T, Pazout J, Krajcova A, Duska F. Echocardiography predictors of sustained sinus rhythm after cardioversion of supraventricular arrhythmia in patients with septic shock. J Crit Care. 2024 Oct;83:154832. doi: 10.1016/j.jcrc.2024.154832. Epub 2024 May 17.
- Derived from this study: PubMed 38372622Waldauf P, Porizka M, Horejsek J, Otahal M, Svobodova E, Jurisinova I, Maly M, Brozek T, Rulisek J, Trachta P, Tencer T, Krajcova A, Duska F, Balik M. The outcomes of patients with septic shock treated with propafenone compared to amiodarone for supraventricular arrhythmias are related to end-systolic left atrial volume. Eur Heart J Acute Cardiovasc Care. 2024 May 28;13(5):414-422. doi: 10.1093/ehjacc/zuae023.
- Derived from this study: PubMed 31481571Balik M, Waldauf P, Maly M, Matousek V, Brozek T, Rulisek J, Porizka M, Sachl R, Otahal M, Brestovansky P, Svobodova E, Flaksa M, Stach Z, Pazout J, Duska F, Smid O, Stritesky M. 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. doi: 10.1136/bmjopen-2019-031678.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Balik, A/Prof principal investigator
Dept of Anaesthesia and Intensive Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propafenone i.v. and Amiodarone i.v. in people with Supraventricular Arrhythmia and Septic Shock, run by Charles University, Czech Republic at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of propafenone (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03029169, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.