Rate, Rhythm or Risk Control for New-onset Supraventricular Arrhythmia During Septic Shock: a Ran… (NCT04844801) | Clinical Trial Compass
RecruitingNot Applicable
Rate, Rhythm or Risk Control for New-onset Supraventricular Arrhythmia During Septic Shock: a Randomized Controlled Trial
France240 participantsStarted 2021-11-09
Plain-language summary
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-group, open-label, randomized controlled superiority trial to compare the effectiveness and safety of these three strategies (risk control, rate control and rhythm control) for NOSVA during septic shock.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \>= 18 years
✓. Septic shock, defined by the association of the following criteria:
✓. NOSVA with heart rate ≥ 110 bpm lasting 5 minutes or more
✓. Written informed consent (patient, next of skin or emergency situation)
✓. Affiliation to a social security system
Exclusion criteria
✕. Refractory shock defined by a dose of noradrenaline BASE or adrenaline BASE \> 1.2 µg/kg/min
✕. Cardiac surgery or cardiac transplant in the previous month
✕. Congenital heart disease other than bicuspid aortic valve, atrial defect or patent foramen ovale.
✕. History of supraventricular arrhythmia prior to the episode of septic shock defined by a permanent TRSVN or paroxysmal TRSVN requiring long-term specific treatment (heart rate reducer and/or antiarrhythmic and/or curative anticoagulation) or permanent NOSVA.
What they're measuring
1
all-cause mortality (a hierarchical criterion)
Timeframe: 28 days
2
the duration of septic shock according to the Finkelstein-Schoenfeld method (a hierarchical criterion).
✕. NOSVA that began more than 48 hours ago \* (or more than 24 hours ago under vasopressor). \* In cases of TRSVN dating back more than 48 hours, the patient may be included after undergoing a transesophageal echocardiogram (only in patients who are intubated and on mechanical ventilation) to rule out the presence of an intracardiac thrombus, coupled with the initiation of curative anticoagulation (in the absence of contraindications contraindication) starting from the transesophageal echocardiography.
✕. Contraindication to amiodarone: history of serious adverse event related to amiodarone, history of lung disease related to amiodarone, history of hyperthyroidism related to amiodarone, PR interval \> 240 ms, severe sinus node dysfunction with no pacemaker, 2°/ 3° atrioventricular block with no pacemaker, QTc\>480 ms, known or treated hyperthyroidism, hypersensitivity to iodine, amiodarone or to any of the excipients, severe hepatocellular insufficiency (prothrombin rate \<20%), diffuse Interstitial Lung Disease.