Comparing rate, rhythm, and risk-control approaches for new atrial arrhythmias during septic shock
Comparison of Three Care Strategies in Cases of New-onset Supraventricular Arrhythmia During Septic Shock : a Randomized Controlled Trial
This trial will try three treatment approaches—risk control, heart-rate control, or rhythm control—for adults who develop new atrial supraventricular arrhythmias during septic shock.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04844801 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) in the ICU with septic shock who develop new-onset supraventricular arrhythmia with heart rate ≥110 bpm lasting at least 5 minutes and who meet study consent and eligibility criteria are eligible.
Not a fit: Patients with prior chronic supraventricular arrhythmia, recent cardiac surgery or transplant, mechanical mitral/aortic prostheses, significant mitral stenosis, refractory shock, or other exclusion criteria may not benefit from these randomized strategies.
Why it matters
Potential benefit: If one strategy proves better, patients could experience more stable blood pressure and heart function with fewer drug-related side effects and possibly lower complications or death.
How similar studies have performed: Observational studies have described these three management approaches, but randomized comparisons are scarce, so this trial addresses a relatively untested question in a randomized design.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.