Informations générales (source: ClinicalTrials.gov)
Comparison of Three Care Strategies in Cases of New-onset Supraventricular Arrhythmia During Septic Shock : a Randomized Controlled Trial
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
novembre 2021
décembre 2023
18 septembre 2025
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. 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 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.
Etablissements
Critères
Tous
Inclusion Criteria:
1. Age >= 18 years
2. Septic shock, defined by the association of the following criteria:
- Documented or suspected infection, with initiation of antibiotic therapy
- Initiation of vasopressors (norepinephrine, epinephrine) for at least 1 hour to
maintain the MAP > 65 mmHg
3. NOSVA with heart rate ≥ 110 bpm lasting 5 minutes or more
4. Written informed consent (patient, next of skin or emergency situation)
5. Affiliation to a social security system
Exclusion Criteria :
1. Refractory shock defined by a dose of noradrenaline BASE or adrenaline BASE > 1.2
µg/kg/min
2. Cardiac surgery or cardiac transplant in the previous month
3. Aortic or mitral mechanical prosthesis, significant mitral stenosis (mitral surface
< 1.5 cm2)
4. Congenital heart disease other than bicuspid aortic valve, atrial defect or patent
foramen ovale.
5. History of supraventricular arrhythmia before septic shock
6. NOSVA lasting at most 36 hrs (or 24 hrs with vasopressors)
7. Electrical cardioversion or use of amiodarone, other antiarrhythmic, or drug
inducing bradycardia (beta-blockers, bradycardic calcium channel blocker, digitalis,
flécaïnamide) in the previous 6 hours before inclusion
8. 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.
9. Kalemia < 3 mmol/L
10. Pregnant or breast feeding women
11. Moribund patient or death expected from underlying disease during the current
admission; Patient deprived of liberty and persons subject to institutional
psychiatric care
12. Participation to another interventional trial on septic shock and/or arrhythmic
disease
1. Age >= 18 years
2. Septic shock, defined by the association of the following criteria:
- Documented or suspected infection, with initiation of antibiotic therapy
- Initiation of vasopressors (norepinephrine, epinephrine) for at least 1 hour to
maintain the MAP > 65 mmHg
3. NOSVA with heart rate ≥ 110 bpm lasting 5 minutes or more
4. Written informed consent (patient, next of skin or emergency situation)
5. Affiliation to a social security system
Exclusion Criteria :
1. Refractory shock defined by a dose of noradrenaline BASE or adrenaline BASE > 1.2
µg/kg/min
2. Cardiac surgery or cardiac transplant in the previous month
3. Aortic or mitral mechanical prosthesis, significant mitral stenosis (mitral surface
< 1.5 cm2)
4. Congenital heart disease other than bicuspid aortic valve, atrial defect or patent
foramen ovale.
5. History of supraventricular arrhythmia before septic shock
6. NOSVA lasting at most 36 hrs (or 24 hrs with vasopressors)
7. Electrical cardioversion or use of amiodarone, other antiarrhythmic, or drug
inducing bradycardia (beta-blockers, bradycardic calcium channel blocker, digitalis,
flécaïnamide) in the previous 6 hours before inclusion
8. 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.
9. Kalemia < 3 mmol/L
10. Pregnant or breast feeding women
11. Moribund patient or death expected from underlying disease during the current
admission; Patient deprived of liberty and persons subject to institutional
psychiatric care
12. Participation to another interventional trial on septic shock and/or arrhythmic
disease