Comparing ways to manage new irregular heartbeat during septic shock
Compares care approaches for new irregular heartbeat in septic shock.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Registry title
- Rate, Rhythm or Risk Control for New-onset Supraventricular Arrhythmia During Septic Shock: a Randomized Controlled Trial
- Status
- Recruiting
- People taking part
- 240 people, planned
- Started
- 9 Nov 2021
- Planned end
- Mar 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Risk control strategy
- Heart-Rate control strategy:
- Rhythm control strategy:
- Record updated
- 7 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in septic shock who have a new fast irregular heartbeat from the upper chambers of the heart. It compares three ways of managing this heart rhythm problem.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Septic shock: a known or suspected infection treated with antibiotics, plus vasopressor drugs for at least 1 hour to keep the mean blood pressure (MAP) above 65 mmHg. New-onset supraventricular arrhythmia with a heart rate of 110 bpm or more for 5 minutes or longer.
- Earlier treatment
- Must not have had electrical cardioversion, amiodarone, other antiarrhythmic drugs or heart-slowing drugs in the 6 hours before joining.
Main reasons for not taking part
- Refractory shock: noradrenaline or adrenaline dose above 1.2 µg/kg/min
- Cardiac surgery or heart transplant in the previous month
- Earlier supraventricular arrhythmia before the septic shock, or arrhythmia that began more than 48 hours ago (more than 24 hours ago on vasopressors), with exceptions in the record
- Cannot take amiodarone for medical reasons, or potassium below 3 mmol/L
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Cardiac surgery or cardiac transplant in the previous month
- 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
- Congenital heart disease other than bicuspid aortic valve, atrial defect or patent foramen ovale
- 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
- 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
- Refractory shock defined by a dose of noradrenaline BASE or adrenaline BASE > 1.2 µg/kg/min
- Aortic or mitral mechanical prosthesis, significant mitral stenosis (mitral surface < 1.5 cm2)
- 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
- Pregnant or breast feeding women
Where in France
- Service de Médecine Intensive Réanimation-Hôpital TenonParis, FranceContact: François BAGATETaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- Risk control strategyExisting treatment, for comparison
Magnesium sulfate + control of the modifiable NOSVA risk factors
- Heart-Rate control strategyExisting treatment, for comparison
Risk-control + "low-dose" amiodarone
- Rhythm control strategyExisting treatment, for comparison
Risk-control + "high-dose" amiodarone +/- electrical cardioversion
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparison of Three Care Strategies in Cases of New-onset Supraventricular Arrhythmia During Septic Shock : a Randomized Controlled Trial
- Plain-language title
- Comparing ways to manage new irregular heartbeat during septic shockGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 7 January 2026