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Study identifier: NCT04844801 Synced from ClinicalTrials.gov · July 28, 2026
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Rate, Rhythm or Risk Control for New-onset Supraventricular Arrhythmia During Septic Shock: a Randomized Controlled Trial

Condition: Supraventricular Arrhythmia · Septic Shock  ·  Sponsor: Assistance Publique - Hôpitaux de Paris

PhaseNA
Planned participants240
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

New-onset supraventricular arrhythmia (NOSVA) is reported in 40 % of patients with septic shock and is associated with hemodynamic alterations and mortality. The lack of consensus regarding best practices for the management of NOSVA in this setting has led to major variations in practice patterns. Observational studies reported three usual strategies: (i) heart rate control (hereafter rate control) with the use of antiarrhythmic drugs, essentially based on low dose of amiodarone, (ii) rhythm control with the use of antiarrhythmic drugs, essentially based on high dose of amiodarone, and electrical cardioversionand (iii) modifiable NOSVA risk factors control (hereafter risk control) without using antiarrhythmic drugs. Risk control would minimize adverse events of antiarrhythmic drugs. Rhythm control would rapidly improve haemodynamics via restoring diastole and decreasing cardiac metabolic demand, while minimizing exposure to anticoagulation. Heart-Rate control, would limit potential adverse events of high dose of amiodarone and of electrical cardioversion (only in patients intubated on mechanical ventilation), while controlling haemodynamics. Therefore, it seems important to compare these three strategies. Our hypothesis is dual: first, that heart-rate control and rhythm control each improve hemodynamics with in fine a decreased mortality, as compared to a risk control; second, that rhythm control outperforms rate control in this setting. This is a multicenter, parallel-gro…

This description comes directly from the study's public registry record.

Talk to the study team

Vincent LABBE, MD  ·  01 56 01 69 37  ·  vincent.labbe@aphp.fr

Armand Mekontso-Dessap  ·  00 33 1 49 81 23 94 (23 89)  ·  armand.dessap@aphp.fr

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Locations (1)

Service de Médecine Intensive Réanimation-Hôpital TenonParis, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT04844801