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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Service de Médecine Intensive Réanimation-Hôpital Tenon
RECRUITING
Paris
Contact Information
Primary
Vincent LABBE, MD
vincent.labbe@aphp.fr
01 56 01 69 37
Backup
Armand Mekontso-Dessap
armand.dessap@aphp.fr
00 33 1 49 81 23 94 (23 89)
Time Frame
Start Date: 2021-11-09
Estimated Completion Date: 2026-03
Participants
Target number of participants: 240
Treatments
Active_comparator: Risk control strategy
Magnesium sulfate + control of the modifiable NOSVA risk factors
Active_comparator: Heart-Rate control strategy
Risk-control + low-dose amiodarone
Active_comparator: Rhythm control strategy
Risk-control + high-dose amiodarone +/- electrical cardioversion
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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