CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 210 enrolled
Drug / intervention
Propafenone i.v. +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03029169
NCT03029169Phase 4Completed

Prospective Randomized Study of Efficacy and Safety of 1c Class Antiarrhythmic Agent (Propafenone) in Septic Shock

Charles University, Czech Republic·interventional·Posted Jan 24, 2017·Updated Aug 2, 2022

In Brief

A Phase 4 clinical trial evaluating Propafenone i.v. and Amiodarone i.v. for Supraventricular Arrhythmia and Septic Shock. Completed, enrolled 210 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 24, 2017
Enrollment StartOct 23, 2017
Primary CompletionJul 4, 2022
Study CompletionAug 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 9.4 years ago

Interventions

Propafenone i.v.drug

Treatment

Amiodarone i.v.drug

Treatment