Supraventricular ArrhythmiaCAFSNCT04844801
Rate, Rhythm or Risk Control for New-onset Supraventricular Arrhythmia During Septic Shock: a Randomized Controlled Trial
A study of Supraventricular Arrhythmia and Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 practices for the management of NOSVA in this setting has led to major variations in practice patterns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supraventricular Arrhythmia, Septic Shock
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2021to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Intensive Réanimation-Hôpital Tenon
Paris, 75020
François BAGATE, +33 1 45 17 85 14, francois.bagate@aphp.fr
Armand Mekontso-Dessap, Professor, 0149812389, armand.dessap@aphp.fr
About this study
Official title: Comparison of Three Care Strategies in Cases of New-onset Supraventricular Arrhythmia During Septic Shock : a Randomized Controlled Trial
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.
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.
Read more
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.
Read the 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.
Randomization, performed immediately after the inclusion (Day-1), in 1:1:1 ratio will be stratified on center. Then the patient will receive the randomized strategy: risk control, rate control or rhythm control.
Before inclusion, the informed consent will be proposed to the patient. If the patient is unable to give his/her consent, the informed consent of the next-of-kin will be sought by study investigator. In the case the next-of-kins are unidentified and/or unreachable, an emergency procedure will be applied. Patient consent will be sought as soon as their state of health allows it.
According to clinical guidelines, patients in all groups will receive therapeutic anticoagulation if NOSVA > 48 hours and in the absence of contraindication. In all groups, recommendations for the management of septic shock will be followed.
After day-7 (or hospital discharge if before J7), NOSVA treatment will be left at the discretion of attending physicians.
Evaluation criteria will be collected at day-2, day-3, day-7 (or at hospital discharge if before day-7), at the day of ICU discharge and at Day-28. If the patient has been discharged before Day-28, the vital status may be obtained by phone call at Day-28.
- Conditions
- Supraventricular Arrhythmia, Septic Shock
- Being tested
- Risk control strategy, Heart-Rate control strategy:, Rhythm control strategy:
- Keywords
- New-onset supraventricular arrhythmia, Atrial fibrillation, Septic shock, Critically ill patient, Strategies, Antiarrhythmic drugs
- Medical subject headings
- Shock, Septic, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk control strategyProcedure or surgery
- Magnesium sulfate 2g intravenous bolus over 20 mn (if creatinine clearance >30 mL/min)
- Control of the modifiable NOSVA risk factors: hypovolemia, sepsis, metabolic disorders (e.g., hypokalemia, hyponatremia), acidosis, hypoxia, excess cardiac inotropism of vasopressors, central venous catheter malposition, hyperthermia.
Heart-Rate control strategy:Procedure or surgery
- Risk-control as described above
- "Low dose" amiodarone:
- Intravenous loading bolus (day-1): bolus of 4 mg/kg IV over 1hour (maximum 300 mg IV over 1 hour )
- Enteral maintenance dose (oral or via gastric tube) (day-1 to day-7) 200mg/24hour in a single dose for 7 days (150 mg intravenous over 1hour if enteral route is unavailable)
Rhythm control strategy:Procedure or surgery
- Risk control as described above
- "High dose" amiodarone:
- Intravenous loading dose (day-1): initial bolus 7 mg/kg over 1 hour (maximum 600 mg i.e. 4 IVL vials over 1 hour); followed by continuous intravenous maintenance: for a total of 1200 mg over the first 24 hours (infusion pump)
- Enteral dose maintenance Day-2 and day-3: 1200 mg/ 24 hours in three doses for 48hours (720 mg continuous intravenous over 24 hours if enteral route is unavailable).
Day-4 to day-7: 200 mg/24 hours once a day (150 mg intravenous over 1hourr if enteral route is unavailable) - Electrical cardioversion (only in patients intubated on mechanical ventilation)
1 to 3 external electric shocks starting at 200J if:
- NOSVA persists after initial bolus of amiodarone AND norepinephrine base (or epinephrine base) doses > 0.3 µg/kg/min;
- NOSVA persists more than 6 hours after initial IV loading dose of amiodarone. NB: Beyond day 7 (or after discharge from intensive care if this occurs before da
| Study group | Role | What they receive |
|---|---|---|
| Risk control strategy | Active comparator | Magnesium sulfate + control of the modifiable NOSVA risk factors Receives: Procedure: Risk control strategy |
| Heart-Rate control strategy | Active comparator | Risk-control + "low-dose" amiodarone Receives: Procedure: Heart-Rate control strategy: |
| Rhythm control strategy | Active comparator | Risk-control + "high-dose" amiodarone +/- electrical cardioversion Receives: Procedure: Rhythm control strategy: |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality (a hierarchical criterion)
The duration of septic shock is defined as the time (number of days) from randomization to successful weaning of vasopressors
The Finkelstein-Schoenfeld method is based on the principle that each patient in the clinical trial is compared with every other patient within each stratum in a pairwise manner. The pairwise comparison proceeds in hierarchical fashion, using all-cause mortality, followed by the duration of septic shock when patients cannot be differentiated on the basis of mortality. This method gives a higher importance to all-cause mortality.
Measured: 28 days
the duration of septic shock according to the Finkelstein-Schoenfeld method (a hierarchical criterion).
The duration of septic shock is defined as the time (number of days) from randomization to successful weaning of vasopressors
The Finkelstein-Schoenfeld method is based on the principle that each patient in the clinical trial is compared with every other patient within each stratum in a pairwise manner. The pairwise comparison proceeds in hierarchical fashion, using all-cause mortality, followed by the duration of septic shock when patients cannot be differentiated on the basis of mortality. This method gives a higher importance to all-cause mortality.
Measured: 28 days
Secondary outcomes (3)
Rhythm efficacy at day-7 (or at discharge or death if before day-7)
- Number of patients with sinus rhythm
- Number of days alive with sinus rhythm
- Number of days alive with NOSVA and heart rate < 110 bpm
- Proportion of patients receiving therapeutic anticoagulation after randomisation
Measured: up to 7 days
Morbimortality
- Duration of septic shock and Length of stay in intensive care unit and in hospital at day-28
- Proportion of patients alive free from vasopressors at day-7 (or at discharge or death if before day-7)
- Arterial lactate clearance at day-3 defined as the percentage of arterial lactate decrease between lactate at randomisation (day-1) and at day-3.
- Proportion of patients alive free from organ dysfunction at day-7 (or at discharge or death if before day-7)
- All-cause deaths at day-28.
Measured: Day 28
Tolerance at day-7 and day-28
- Proportion of patients with at least one arterial thrombotic event including ischemic stroke and non-cerebrovascular arterial thrombotic event
- Proportion of patients with at least one major bleeding event according to the International Society of Thrombosis and Haemostasis definition at Day-28;
- Proportion of patients with at least one serious adverse event related to amiodarone or to magnesium sulfate; and proportion of each type of event
- Proportion of patients presenting at least one serious adverse event associated with electrical cardioversion (for patients receiving electrical cardioversion).
Measured: Day 7 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start9 Nov 2021
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraventricular ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent LABBE, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844801
- Sponsor's protocol ID
- APHP190070
- Acronym
- CAFS
- Status last verified
- Jan 2026
- First submitted
- 26 Feb 2021
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Labbe V, Desnos C, Preau S, Doyen D, Contou D, Bagate F, Souweine B, Pey V, Bertrand PM, Muller G, Boissier F, Asfar P, Bonnet N, Joffre J, Sy O, Dres M, Annoni F, Monnet X, Carreira S, Vivier E, Serck N, Wiart A, Voicu S, Heming N, Le Breton C, Chevrel G, Chemouni F, Piagnerelli M, Haentjens L, Fartoukh M, Taccone F, Durand D, Monthieux G, Berard L, Rousseau A, Mekontso Dessap A. Risk, rate or rhythm control for new onset supraventricular arrhythmia during septic shock: protocol for the CAFS multicentre, parallel-group, open-label trial. BMJ Open. 2025 Apr 1;15(4):e090404. doi: 10.1136/bmjopen-2024-090404.
PubMed 40169282
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Care Strategies in Cases of New-onset Supraventricular Arrhythmia During Septic Shock : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04844801
- Acronym / sponsor ID
- CAFS / APHP190070
- Conditions
- Supraventricular Arrhythmia, Septic Shock
- Keywords
- New-onset supraventricular arrhythmia, Atrial fibrillation, Septic shock, Critically ill patient, Strategies, Antiarrhythmic drugs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Randomization, performed immediately after the inclusion (Day-1), in 1:1:1 ratio will be stratified on center. Then the patient will receive the randomized strategy: risk control, rate control or rhythm control.
Before inclusion, the informed consent will be proposed to the patient. If the patient is unable to give his/her consent, the informed consent of the next-of-kin will be sought by study investigator. In the case the next-of-kins are unidentified and/or unreachable, an emergency procedure will be applied. Patient consent will be sought as soon as their state of health allows it.
According to clinical guidelines, patients in all groups will receive therapeutic anticoagulation if NOSVA > 48 hours and in the absence of contraindication. In all groups, recommendations for the management of septic shock will be followed.
After day-7 (or hospital discharge if before J7), NOSVA treatment will be left at the discretion of attending physicians.
Evaluation criteria will be collected at day-2, day-3, day-7 (or at hospital discharge if before day-7), at the day of ICU discharge and at Day-28. If the patient has been discharged before Day-28, the vital status may be obtained by phone call at Day-28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Risk control strategy | Active comparator | Procedure: Risk control strategyMagnesium sulfate + control of the modifiable NOSVA risk factors |
| Heart-Rate control strategy | Active comparator | Procedure: Heart-Rate control strategy:Risk-control + "low-dose" amiodarone |
| Rhythm control strategy | Active comparator | Procedure: Rhythm control strategy:Risk-control + "high-dose" amiodarone +/- electrical cardioversion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >= 18 years
- Septic shock, defined by the association of the following criteria:
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk control strategy* Magnesium sulfate 2g intravenous bolus over 20 mn (if creatinine clearance >30 mL/min) * Control of the modifiable NOSVA risk factors: hypovolemia, sepsis, metabolic disorders (e.g., hypokalemia, hyponatremia), acidosis, hypoxia, excess cardiac inotropism of vasopressors, central venous catheter malposition, hyperthermia. | Procedure or surgery | Risk control strategy |
| Heart-Rate control strategy:* Risk-control as described above * "Low dose" amiodarone: * Intravenous loading bolus (day-1): bolus of 4 mg/kg IV over 1hour (maximum 300 mg IV over 1 hour ) * Enteral maintenance dose (oral or via gastric tube) (day-1 to day-7) 200mg/24hour in a single dose for 7 days (150 mg intravenous over 1hour if enteral route is unavailable) | Procedure or surgery | Heart-Rate control strategy |
| Rhythm control strategy:* Risk control as described above * "High dose" amiodarone: * Intravenous loading dose (day-1): initial bolus 7 mg/kg over 1 hour (maximum 600 mg i.e. 4 IVL vials over 1 hour); followed by continuous intravenous maintenance: for a total of 1200 mg over the first 24 hours (infusion pump) * Enteral dose maintenance Day-2 and day-3: 1200 mg/ 24 hours in three doses for 48hours (720 mg continuous intravenous over 24 hours if enteral route is unavailable). Day-4 to day-7: 200 mg/24 hours once a day (150 mg intravenous over 1hourr if enteral route is unavailable) - Electrical cardioversion (only in patients intubated on mechanical ventilation) 1 to 3 external electric shocks starting at 200J if: * NOSVA persists after initial bolus of amiodarone AND norepinephrine base (or epinephrine base) doses > 0.3 µg/kg/min; * NOSVA persists more than 6 hours after initial IV loading dose of amiodarone. NB: Beyond day 7 (or after discharge from intensive care if this occurs before da | Procedure or surgery | Rhythm control strategy |
Primary outcome
all-cause mortality (a hierarchical criterion)
Time frame: 28 days
The duration of septic shock is defined as the time (number of days) from randomization to successful weaning of vasopressors The Finkelstein-Schoenfeld method is based on the principle that each patient in the clinical trial is compared with every other patient within each stratum in a pairwise manner. The pairwise comparison proceeds in hierarchical fashion, using all-cause mortality, followed by the duration of septic shock when patients cannot be differentiated on the basis of mortality. This method gives a higher importance to all-cause mortality.
the duration of septic shock according to the Finkelstein-Schoenfeld method (a hierarchical criterion).
Time frame: 28 days
The duration of septic shock is defined as the time (number of days) from randomization to successful weaning of vasopressors The Finkelstein-Schoenfeld method is based on the principle that each patient in the clinical trial is compared with every other patient within each stratum in a pairwise manner. The pairwise comparison proceeds in hierarchical fashion, using all-cause mortality, followed by the duration of septic shock when patients cannot be differentiated on the basis of mortality. This method gives a higher importance to all-cause mortality.
3 secondary outcomes
Rhythm efficacy at day-7 (or at discharge or death if before day-7)
Time frame: up to 7 days
Morbimortality
Time frame: Day 28
Tolerance at day-7 and day-28
Time frame: Day 7 and day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 40169282Labbe V, Desnos C, Preau S, Doyen D, Contou D, Bagate F, Souweine B, Pey V, Bertrand PM, Muller G, Boissier F, Asfar P, Bonnet N, Joffre J, Sy O, Dres M, Annoni F, Monnet X, Carreira S, Vivier E, Serck N, Wiart A, Voicu S, Heming N, Le Breton C, Chevrel G, Chemouni F, Piagnerelli M, Haentjens L, Fartoukh M, Taccone F, Durand D, Monthieux G, Berard L, Rousseau A, Mekontso Dessap A. Risk, rate or rhythm control for new onset supraventricular arrhythmia during septic shock: protocol for the CAFS multicentre, parallel-group, open-label trial. BMJ Open. 2025 Apr 1;15(4):e090404. doi: 10.1136/bmjopen-2024-090404.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent LABBE, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Supraventricular Arrhythmia and Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent LABBE, MD (01 56 01 69 37, vincent.labbe@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (a hierarchical criterion) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04844801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.