Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ve… (NCT03715556) | Clinical Trial Compass
UnknownPhase 3
Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ventricular Response
Brazil126 participantsStarted 2018-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.