Comparing rate, rhythm, and risk-control approaches for new atrial arrhythmias during septic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Consecutive adult ICU patients with septic shock who develop new-onset supraventricular arrhythmia are randomized 1:1:1 by center to receive a risk-control strategy (no antiarrhythmics, manage reversible factors), a rate-control strategy (lower heart rate, primarily low-dose amiodarone), or a rhythm-control strategy (restore sinus rhythm using higher-dose amiodarone and/or electrical cardioversion). Randomization occurs immediately after inclusion and standard septic shock care is continued in all groups, with anticoagulation per guidelines if arrhythmia >48 hours. Clinical outcomes and safety are collected at day 2, day 3, day 7 (or hospital discharge), ICU discharge, and day 28. After day 7 (or earlier discharge) arrhythmia treatment is left to the treating team.

Why it matters

Who can join: the full rules

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 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.
6. 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.
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

Where it's running

• Service de Médecine Intensive Réanimation-Hôpital Tenon
  Paris, France Recruiting

Study contacts

• Principal investigator: Vincent LABBE, MD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Vincent LABBE, MD
• Email: vincent.labbe@aphp.fr
• Phone: 01 56 01 69 37

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.