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Heart rhythm crisis in sepsis: which strategy saves more lives?

NCT ID NCT04844801

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 240 adults with septic shock who develop a new, fast heart rhythm problem. It compares three treatment approaches: controlling heart rate with low-dose amiodarone, restoring normal rhythm with high-dose amiodarone or electric shock, or managing risk factors without antiarrhythmic drugs. The goal is to see which strategy reduces death and shortens shock duration.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Service de Médecine Intensive Réanimation-Hôpital Tenon

    RECRUITING

    Paris, 75020, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.