- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04844801
Rate, Rhythm or Risk Control for New-onset Supraventricular Arrhythmia During Septic Shock: a Randomized Controlled Trial (CAFS)
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. 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 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Vincent LABBE, MD
- Telefonní číslo: 01 56 01 69 37
- E-mail: vincent.labbe@aphp.fr
Studijní místa
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Paris, Francie, 75020
- Nábor
- Service de Médecine Intensive Réanimation-Hôpital Tenon
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Kontakt:
- Vincent LABEE, MD
- Telefonní číslo: 01 56 01 69 37
- E-mail: vincent.labbe@aphp.fr
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Kontakt:
- Armand Mekontso-Dessap, Professor
- Telefonní číslo: 0149812389
- E-mail: armand.dessap@aphp.fr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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
Exclusion Criteria :
- 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 before septic shock
- NOSVA lasting at most 36 hrs (or 24 hrs with vasopressors)
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: Risk control strategy
Magnesium sulfate + control of the modifiable NOSVA risk factors
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|
Aktivní komparátor: Rate control strategy
Risk-control + "low-dose" amiodarone
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Aktivní komparátor: Rhythm control strategy
Risk-control + "high-dose" amiodarone +/- electrical cardioversion
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Day-4 to day-7: 200 mg once a day (150 mg intravenous over 1hr if enteral route is unavailable) - Electrical cardioversion (only in patients intubated on mechanical ventilation) if:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
all-cause mortality (a hierarchical criterion)
Časové okno: 28 days
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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. |
28 days
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the duration of septic shock according to the Finkelstein-Schoenfeld method (a hierarchical criterion).
Časové okno: 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. |
28 days
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Rhythm efficacy at day-7 (or at discharge or death if before day-7)
Časové okno: up to 7 days
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up to 7 days
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Morbimortality
Časové okno: Day 28
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Day 28
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Tolerance at day-7 and day-28
Časové okno: Day 7 and day 28
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Day 7 and day 28
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Vincent LABBE, MD, Assistance Publique - Hôpitaux de Paris
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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