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

NCT ID: NCT03715556

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2021-12-01

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Amiodarone

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.

Group Type: ACTIVE_COMPARATOR

Amiodarone

Intervention Type: DRUG

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

Intervention Type: DRUG

Administration of 0.9% physiological solution.

No intervention

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

Group Type: PLACEBO_COMPARATOR

0.9% physiological solution

Intervention Type: DRUG

Administration of 0.9% physiological solution.

Interventions

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.

Intervention Type: DRUG

0.9% physiological solution

Administration of 0.9% physiological solution.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mucio Tavares, MD

Role: PRINCIPAL_INVESTIGATOR

Unidade Clínica de Emergência

Locations

Instituto do Coração - HMFMUSP

São Paulo, , Brazil

Countries

Brazil

Central Contacts

Alexandre Soeiro, MD

Role: CONTACT

alexandre.soeiro@bol.com.br

+55112661-5299

Other Identifiers

PSInCor-FAARVSepsis

Identifier Type: -

Identifier Source: org_study_id