SepsisPhase 3FAARVNCT03715556
Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ventricular Response
A Phase 3 study testing Amiodarone and 0.9% physiological solution in people with Sepsis and Septic Shock, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Atrial Fibrillation
- What is being tested?
- Amiodarone and 0.9% physiological solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2018to 1 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Contraindication to the use of amiodarone
- Child C cirrhosis
- Dialytic chronic renal insufficiency
- Chronic obstructive pulmonary disease
- Acute myocarditis
- Pulmonary thromboembolism
- Terminal neoplasia
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Amiodarone, 0.9% physiological solution
- Medical subject headings
- Sepsis, Shock, Septic, Atrial Fibrillation, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmiodaroneDrug
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 solutionDrug
Administration of 0.9% physiological solution.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 0.9% physiological solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (1)
Effectiveness in the control of the heart rate
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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mucio Tavares, MD, Principal investigator, Unidade Clínica de Emergência
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715556
- Sponsor's protocol ID
- PSInCor-FAARVSepsis
- Acronym
- FAARV
- Status last verified
- Oct 2018
- First submitted
- 19 Oct 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03715556
- Acronym / sponsor ID
- FAARV / PSInCor-FAARVSepsis
- Conditions
- Sepsis, Septic Shock, Atrial Fibrillation, Ventricular Fibrillation, Atrial Fibrillation Rapid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amiodarone | Active comparator | Drug: Amiodarone, Drug: 0.9% physiological solutionAmiodarone (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. |
| No intervention | Placebo comparator | Drug: 0.9% physiological solutionThe Liberal group will receive only 0.9% physiological solution, also blinded to the principal investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmiodaroneAdministration 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 | Amiodarone |
| 0.9% physiological solutionAdministration of 0.9% physiological solution. | Drug | Amiodarone, No intervention |
Primary outcome
Complications of safety outcomes
Time frame: 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
1 secondary outcome
Effectiveness in the control of the heart rate
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mucio Tavares, MD principal investigator
Unidade Clínica de Emergência
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amiodarone and 0.9% physiological solution in people with Sepsis and Septic Shock, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Soeiro, MD (+55112661-5299, alexandre.soeiro@bol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications of safety outcomes (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.