Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-24 @ 2:31 PM
Study NCT ID:
NCT03029169
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2016-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Propafenone Versus Amiodarone in Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Provided by a dedicated study nurse'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2017-01-20', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of propafenone', 'timeFrame': '1 year', 'description': 'cardioversion rate'}, {'measure': 'ICU mortality of septic shock patients on propafenone for a SV arrhythmia', 'timeFrame': '1 year', 'description': 'ICU mortality'}, {'measure': '28-day mortality of septic shock patients on propafenone for a SV arrhythmia', 'timeFrame': '2 years', 'description': '28-day mortality'}, {'measure': '12-month mortality of septic shock patients on propafenone for a SV arrhythmia', 'timeFrame': '2 years', 'description': '12-month mortality'}], 'secondaryOutcomes': [{'measure': 'Electromechanics of left atrium', 'timeFrame': '1 year', 'description': 'left atrial emptying'}, {'measure': 'Electromechanics of LA', 'timeFrame': '1 year', 'description': 'isovolumic and ejection times'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Supraventricular Arrhythmia', 'Septic shock', 'Propafenone', 'Amiodarone', 'Intensive Care'], 'conditions': ['Supraventricular Arrhythmia', 'Septic Shock']}, 'referencesModule': {'references': [{'pmid': '38759581', 'type': 'DERIVED', 'citation': 'Balik 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.'}, {'pmid': '38372622', 'type': 'DERIVED', 'citation': 'Waldauf 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.'}, {'pmid': '31481571', 'type': 'DERIVED', 'citation': 'Balik 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Septic shock with a new onset SV arrhythmia\n* LV systolic function normal to moderately reduced according to echocardiography.\n\nExclusion Criteria:\n\n* Severe LV systolic dysfunction\n* More than 1st degree AV block\n* High dose vasopressor therapy with continuous noradrenaline \\> 1.0 ug/kg.min\n* Known intolerance to amiodarone or propafenone\n* Absence of septic shock\n* Chronic AF\n* Dependence on pacemaker\n* Status after MAZE procedure'}, 'identificationModule': {'nctId': 'NCT03029169', 'acronym': 'PRASE', 'briefTitle': 'Propafenone Versus Amiodarone in Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Prospective Randomized Study of Efficacy and Safety of 1c Class Antiarrhythmic Agent (Propafenone) in Septic Shock', 'orgStudyIdInfo': {'id': '1691/16 S-IV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propafenone i.v.', 'description': '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.\n\nIntervention: Bolus of 35-70 mg intravenous propafenone followed by continuous infusion of 400-840 mg/24h.', 'interventionNames': ['Drug: Propafenone i.v.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amiodarone i.v.', 'description': '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.\n\nIntervention: Bolus of 150-300 mg of intravenous amiodarone followed by continuous infusion of 600-1800 mg/24h.', 'interventionNames': ['Drug: Amiodarone i.v.']}], 'interventions': [{'name': 'Propafenone i.v.', 'type': 'DRUG', 'otherNames': ['Antiarrhythmic therapy'], 'description': 'Treatment', 'armGroupLabels': ['Propafenone i.v.']}, {'name': 'Amiodarone i.v.', 'type': 'DRUG', 'otherNames': ['Antiarrhythmic therapy'], 'description': 'Treatment', 'armGroupLabels': ['Amiodarone i.v.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100 34', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Dept. Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Martin Balik, A/Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Anaesthesia and Intensive Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'A/Prof, MD, PhD', 'investigatorFullName': 'Martin Balik', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}