RecruitingNot ApplicableNCT04844801

Rate, Rhythm or Risk Control for New-onset Supraventricular Arrhythmia During Septic Shock: a Randomized Controlled Trial

Comparison of Three Care Strategies in Cases of New-onset Supraventricular Arrhythmia During Septic Shock : a Randomized Controlled Trial


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

240 participants

Start Date

Nov 9, 2021

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the best way to manage a rapid, irregular heart rate (supraventricular arrhythmia) that develops during septic shock — a life-threatening infection-related condition — to see whether controlling rate, restoring normal rhythm, or focusing on other risk factors leads to better patient outcomes. **You may be eligible if:** - You are 18 or older - You are being treated in intensive care for septic shock (serious infection requiring blood pressure support) - You have developed a new fast and irregular heartbeat (heart rate at or above 110 bpm for 5 or more minutes) **You may NOT be eligible if:** - Your shock is extremely severe and not responding to medications - You have had heart surgery or a transplant in the past month - You have a mechanical heart valve or significant mitral stenosis - You have a pre-existing heart rhythm disorder requiring ongoing treatment - You are pregnant or breastfeeding - You have contraindications to amiodarone (a heart rhythm medication) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERisk 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.

PROCEDUREHeart-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)

PROCEDURERhythm 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


Locations(1)

Service de Médecine Intensive Réanimation-Hôpital Tenon

Paris, France

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NCT04844801


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