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

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Amiodarone; Pharmaceutical Solutions

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