Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ventricular Response (FAARV)

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 3

Conditions: Atrial Fibrillation; Atrial Fibrillation Rapid; Ventricular Fibrillation; Septic Shock; Sepsis

Treatments: Drug: 0.9% physiological solution; Drug: Amiodarone

Study type: Interventional

Funder types: Other

Identifiers

NCT03715556

PSInCor-FAARVSepsis

Details and patient eligibility

About

Amiodarone is considered the medicine of choice in heart rate control in critically ill patients with atrial fibrillation with high ventricular response. However, a recent retrospective study showed a greater number of events in critical patients in whom there was an attempt to control versus in which there was no. Therefore, the prospective and randomized comparative use of amiodarone in this group of patients has not yet been described. The aim of this study was to evaluate the safety of the use of amiodarone (restricted group) versus placebo (liberal group) in heart rate control in atrial fibrillation with high ventricular response in patients with sepsis and vasopressor cardiovascular dysfunction. For this, a unicentric, randomized, blind and prospective study will be performed, in which the restrictive versus liberal strategy is performed in a comparative way. Hospital data (test results, medical evolutions complications) of patients will be analyzed to calculate safety and effectiveness. Expected results: The liberal strategy is superior to the restrictive strategy and causes fewer adverse events.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Permanent FA presence with FC> 110 bpm
• Presence of infection (any infectious outbreak)
• Cardiovascular dysfunction - need for vasopressor drugs (noradrenaline, adrenaline or vasopressin) to maintain SBP> 90 mmHg
• Signed consent form

Exclusion criteria

• Pregnancy
• Body mass index greater than 40 kg / m2
• Contraindication to the use of oral or parenteral anticoagulants
• Acute coronary syndrome
• Left ventricular ejection fraction <35%
• Valvular Heart Disease
• Contraindication to the use of amiodarone
• Child C cirrhosis
• Dialytic chronic renal insufficiency
• Chronic obstructive pulmonary disease
• Acute myocarditis
• Pulmonary thromboembolism
• Terminal neoplasia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups, including a placebo group

Amiodarone

Active Comparator group

Description:

Amiodarone (5 mg / kg EV in 30 minutes) will be the drug of choice in the Restricted group blinded to the principal investigator. If there is no reversal / control and there is no adverse event, a further dose of the same previously administered medicinal product will be performed within 30 minutes, amiodarone 3 mg / kg. After the second dose, continuous infusion of amiodarone at a dose of 900 mg in 24 hours will be initiated. Administration of the drug will be blinded within the first hour to the principal investigator.

Treatment:

Drug: 0.9% physiological solution

Drug: Amiodarone

No intervention

Placebo Comparator group

Description:

The Liberal group will receive only 0.9% physiological solution, also blinded to the principal investigator.

Treatment:

Drug: 0.9% physiological solution