Status:
RECRUITING
Rate, Rhythm or Risk Control for New-onset Supraventricular Arrhythmia During Septic Shock: a Randomized Controlled Trial
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Supraventricular Arrhythmia
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pract...
Detailed Description
All consecutive adult patients admitted to the intensive care unit with NOSVA during septic shock will be included in the presence of inclusion criteria and in the absence of exclusion criteria. Rand...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age \>= 18 years
- 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
- 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
- Aortic or mitral mechanical prosthesis, significant mitral stenosis (mitral surface \< 1.5 cm2)
- 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.
- 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.
- 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
- 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.
- Kalemia \< 3 mmol/L
- Pregnant or breast feeding women
- Moribund patient or death expected from underlying disease during the current admission; Patient deprived of liberty and persons subject to institutional psychiatric care
- Participation to another interventional trial on septic shock and/or arrhythmic disease
Exclusion
Key Trial Info
Start Date :
November 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04844801
Start Date
November 9 2021
End Date
March 1 2026
Last Update
January 7 2026
Active Locations (1)
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1
Service de Médecine Intensive Réanimation-Hôpital Tenon
Paris, France, 75020