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

NCT03715556 | Unknown Phase 3

• 1 other identifier: PSInCor-FAARVSepsis
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effectiveness in the control of the heart rate

  48 hours

Study Arms (2)

Amiodarone

ACTIVE COMPARATOR

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.

Drug: Amiodarone; Drug: 0.9% physiological solution

No intervention

PLACEBO COMPARATOR

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

Drug: 0.9% physiological solution

Interventions

Amiodarone 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.

Amiodarone

0.9% physiological solution DRUG

Administration of 0.9% physiological solution.

Amiodarone; No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração - HMFMUSP

São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic; Atrial Fibrillation; Ventricular Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mucio Tavares, MD

  Unidade Clínica de Emergência

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Soeiro, MD

CONTACT

+55112661-5299; alexandre.soeiro@bol.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

BR (1)