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

Atrial Fibrillation Clinical Trial

— FAARV  

Official title:

Prospective, Randomized and Blind Comparative Analysis Between Attraction of Restrict Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ventricular Response

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03715556
• Other study ID #: PSInCor-FAARVSepsis
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: October 2018
• Source: University of Sao Paulo General Hospital
• Contact: Alexandre Soeiro, MD
• Phone: +55112661-5299
• Email: alexandre.soeiro[@]bol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Rapid
• Sepsis
• Septic Shock
• Shock, Septic
• Ventricular Fibrillation

Intervention

Drug:
• Amiodarone
Administration of the drug will be blinded within the first 48 hours for the principal investigator. 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.
• 0.9% physiological solution
Administration of 0.9% physiological solution.

Locations

Country	Name	City	State
Brazil	Instituto do Coração - HMFMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications of safety outcomes	Need for orotracheal intubation, Bradycardia requiring specific treatment or transvenous pacemaker, Confirmed embolic event, Need for association of another vasoactive drug or dose increase of already used vasoactive drug> 50% of initial, Cardiorespiratory arrest, Death	48 hours
Secondary	Effectiveness in the control of the heart rate	Comparison between the effectiveness in the control of the heart rate of AF among patients of the Restricted versus Liberal group. Effective control will be considered when the patient reaches heart rate <100 bpm	48 hours