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Trial record 2 of 234 for:    Charles Martin

Propafenone Versus Amiodarone in Septic Shock (PRASE)

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ClinicalTrials.gov Identifier: NCT03029169
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Balik, Charles University, Czech Republic

Brief 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 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.

Condition or disease Intervention/treatment Phase
Supraventricular Arrhythmia Septic Shock Drug: Propafenone i.v. Drug: Amiodarone i.v. Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Provided by a dedicated study nurse
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Efficacy and Safety of 1c Class Antiarrhythmic Agent (Propafenone) in Septic Shock
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: 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.

Drug: Propafenone i.v.
Treatment
Other Name: Antiarrhythmic therapy

Active Comparator: 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.

Drug: Amiodarone i.v.
Treatment
Other Name: Antiarrhythmic therapy




Primary Outcome Measures :
  1. Efficacy of propafenone [ Time Frame: 1 year ]
    cardioversion rate

  2. ICU mortality of septic shock patients on propafenone for a SV arrhythmia [ Time Frame: 1 year ]
    ICU mortality

  3. 28-day mortality of septic shock patients on propafenone for a SV arrhythmia [ Time Frame: 2 years ]
    28-day mortality

  4. 12-month mortality of septic shock patients on propafenone for a SV arrhythmia [ Time Frame: 2 years ]
    12-month mortality


Secondary Outcome Measures :
  1. Electromechanics of left atrium [ Time Frame: 1 year ]
    left atrial emptying

  2. Electromechanics of LA [ Time Frame: 1 year ]
    isovolumic and ejection times



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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Septic shock with a new onset SV arrhythmia
  • LV systolic function normal to moderately reduced according to echocardiography.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029169


Contacts
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Contact: Martin Balik, A/Prof +420224963366 martin.balik@vfn.cz

Locations
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Czechia
Dept. Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University Recruiting
Prague 10, Czechia, 100 34
Contact: Petr Waldauf, MD    +420267163410    petrwaldauf@gmail.com   
Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University Recruiting
Prague 2, Czechia, 128 08
Contact: Martin Balik, A/Prof    +420224963366    martin.balik@vfn.cz   
Principal Investigator: Martin Balik, MD, PhD         
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
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Principal Investigator: Martin Balik, A/Prof Dept of Anaesthesia and Intensive Care

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Martin Balik, A/Prof, MD, PhD, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT03029169     History of Changes
Other Study ID Numbers: 1691/16 S-IV
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martin Balik, Charles University, Czech Republic:
Supraventricular Arrhythmia
Septic shock
Propafenone
Amiodarone
Intensive Care
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Amiodarone
Propafenone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Voltage-Gated Sodium Channel Blockers