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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03715556

Collaborator

(none)

126

Enrollment

Location

Arms

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Septic Shock Atrial Fibrillation Ventricular Fibrillation Atrial Fibrillation Rapid	Drug: Amiodarone Drug: 0.9% physiological solution	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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. Drug: 0.9% physiological solution Administration of 0.9% physiological solution.
Placebo Comparator: No intervention The Liberal group will receive only 0.9% physiological solution, also blinded to the principal investigator.	Drug: 0.9% physiological solution Administration of 0.9% physiological solution.

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Drug: 0.9% physiological solution

Administration of 0.9% physiological solution.

Placebo Comparator: No intervention

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

Drug: 0.9% physiological solution

Administration of 0.9% physiological solution.

Outcome Measures

Primary Outcome Measures

Complications of safety outcomes [48 hours]
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

Secondary Outcome Measures

Effectiveness in the control of the heart rate [48 hours]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto do Coração - HMFMUSP	São Paulo		Brazil	05403000

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

Principal Investigator: Mucio Tavares, MD, Unidade Clínica de Emergência

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Sao Paulo General Hospital

ClinicalTrials.gov Identifier:

NCT03715556

Other Study ID Numbers:

PSInCor-FAARVSepsis

First Posted:

Oct 23, 2018

Last Update Posted:

Oct 23, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Ventricular Fibrillation

Amiodarone

Study Results

No Results Posted as of Oct 23, 2018