Cardiac Output, LowPhase 3DOBUTACSNCT02361801
Liberal Versus Restrictive Use of Dobutamine in Cardiac Surgery
A Phase 3 study testing Liberal dobutamine protocol and Restrictive dobutamine protocol in people with Cardiac Output, Low and Coronary Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Inotropic agents are usually administered in the postoperative period after cardiac surgery. In most cases, dobutamine is administered routinely, for the probable occurrence of myocardial dysfunction after cardiopulmonary bypass or a low cardiac output with minimal evidence of altered tissue perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Low, Coronary Disease
- What is being tested?
- Liberal dobutamine protocol and Restrictive dobutamine protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Jun 2018
- 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
- Patients undergoing cardiac surgery of coronary artery bypass graft (CABG) with cardiopulmonary bypass;
- Age equal or greater than 18 years;
- Written informed consent.
Who cannot join
- Previous ventricular dysfunction (ejection fraction lower than 50%)
- Sustained supraventricular or ventricular arrhythmias;
- Cardiogenic shock or need for inotropes before surgery;
- Immediate need of ventricular assist device or intraaortic balloon after CPB;
- Combined procedure;
- Pregnancy;
- Participation in another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Liberal Versus Restrictive Dobutamine in Cardiac Surgery (DOBUTACS): a Prospective Randomized Non-inferiority Clinical Trial
Inotropic agents are usually administered in the postoperative period after cardiac surgery. In most cases, dobutamine is administered routinely, for the probable occurrence of myocardial dysfunction after cardiopulmonary bypass or a low cardiac output with minimal evidence of altered tissue perfusion.
Recent data show that inotropic agents are used in 35-52% of cardiac surgeries in the perioperative period. However, the use of inotropic agents may be associated with adverse events, including myocardial ischemia, by elevation in myocardial oxygen consumption and the imbalance between supply and consumption, and tachyarrhythmias (atrial fibrillation, sinus tachycardia, ventricular tachyarrhythmias), primarily due to the β1-adrenergic effect.
This study is a non-inferiority clinical randomized study aiming to compare the use of dobutamine in a liberal strategy (in all patients at the time of withdrawal of CPB) with a restrictive strategy (based on clinical and hemodynamic evidence of low cardiac output syndrome associated with altered tissue perfusion). Our primary hypothesis is that the restrictive use of dobutamine is as safe and effective as the liberal one.
- Conditions
- Cardiac Output, Low, Coronary Disease
- Being tested
- Liberal dobutamine protocol, Restrictive dobutamine protocol
- Keywords
- cardiac surgery, dobutamine
- Medical subject headings
- Cardiac Output, Low, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal dobutamine protocolDrug
All patients will receive dobutamine at the cardiopulmonary bypass weaning.
Restrictive dobutamine protocolDrug
Patients will receive dobutamine during the first 8 hours after cardiopulmonary bypass weaning only if they have a cardiac index of ≤ 2.5L/min/m2 and at least one sign of tissue hypoperfusion: ScvO2 ≤ 70% and / or urine output < 2 mL/Kg/h despite adequate fluid replacement.
| Study group | Role | What they receive |
|---|---|---|
| Liberal dobutamine group | Active comparator | All patients will receive dobutamine at the cardiopulmonary bypass weaning Receives: Drug: Liberal dobutamine protocol |
| Restrictive dobutamine group | Active comparator | Patients will only receive dobutamine if they present clinical signs of cardiogenic shock Receives: Drug: Restrictive dobutamine protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint of arrhythmias (ventricular and supraventricular), acute myocardial infarction, stroke or transient ischemic attack, low-output syndrome, cardiogenic shock and death from all causes within 30 days after cardiac surgery
Measured: 30 days
Secondary outcomes (10)
Mortality rate
We will compare the mortality rate between groups within 30 days after randomization
Measured: 30 days
Acute myocardial infarction incidence
We will compare the incidence of acute myocardial infarction between groups within 30 days after randomization
Measured: 30 days
Stroke incidence
We will compare the incidence of stroke between groups within 30 days after randomization
Measured: 30 days
Low cardiac output syndrome
We will compare the incidence of low cardiac output syndrome between groups within 30 days after randomization
Measured: 30 days
Cardiogenic shock
We will compare the incidence of cardiogenic shock between groups within 30 days after randomization
Measured: 30 days
Cardiac arrhythmias
We will compare the incidence of ventricular and supraventricular arrhythmias between groups within 30 days after randomization
Measured: 30 days
ICU and hospital length of stay
Measured: 30 days
Days free of mechanical ventilation
We will compare the number of days free of mechanical ventilation between groups within 30 days after randomization
Measured: 30 days
Severe sepsis and septic shock
We will compare the incidence of severe sepsis and septic shock between groups within 30 days after randomization
Measured: 30 days
SOFA score within 72 hours
We will compare the SOFA score between groups 72 hours after randomization
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ludhmila Abrahão Hajjar MD, PhD, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361801
- Sponsor's protocol ID
- DOBUTACS
- Acronym
- DOBUTACS
- Status last verified
- Mar 2022
- First submitted
- 2 Feb 2015
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Franco RA, de Almeida JP, Landoni G, Scheeren TWL, Galas FRBG, Fukushima JT, Zefferino S, Nardelli P, de Albuquerque Piccioni M, Arita ECTC, Park CHL, Cunha LCC, de Oliveira GQ, Costa IBSDS, Kalil Filho R, Jatene FB, Hajjar LA. Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial. Ann Intensive Care. 2021 Jan 26;11(1):15. doi: 10.1186/s13613-021-00808-6.
PubMed 33496877
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberal Versus Restrictive Dobutamine in Cardiac Surgery (DOBUTACS): a Prospective Randomized Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT02361801
- Acronym / sponsor ID
- DOBUTACS / DOBUTACS
- Conditions
- Cardiac Output, Low, Coronary Disease
- Keywords
- cardiac surgery, dobutamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 12 Feb 2015 (estimated)
- 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.
Inotropic agents are usually administered in the postoperative period after cardiac surgery. In most cases, dobutamine is administered routinely, for the probable occurrence of myocardial dysfunction after cardiopulmonary bypass or a low cardiac output with minimal evidence of altered tissue perfusion.
Recent data show that inotropic agents are used in 35-52% of cardiac surgeries in the perioperative period. However, the use of inotropic agents may be associated with adverse events, including myocardial ischemia, by elevation in myocardial oxygen consumption and the imbalance between supply and consumption, and tachyarrhythmias (atrial fibrillation, sinus tachycardia, ventricular tachyarrhythmias), primarily due to the β1-adrenergic effect.
This study is a non-inferiority clinical randomized study aiming to compare the use of dobutamine in a liberal strategy (in all patients at the time of withdrawal of CPB) with a restrictive strategy (based on clinical and hemodynamic evidence of low cardiac output syndrome associated with altered tissue perfusion). Our primary hypothesis is that the restrictive use of dobutamine is as safe and effective as the liberal one.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal dobutamine group | Active comparator | Drug: Liberal dobutamine protocolAll patients will receive dobutamine at the cardiopulmonary bypass weaning |
| Restrictive dobutamine group | Active comparator | Drug: Restrictive dobutamine protocolPatients will only receive dobutamine if they present clinical signs of cardiogenic shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing cardiac surgery of coronary artery bypass graft (CABG) with cardiopulmonary bypass;
- Age equal or greater than 18 years;
- Written informed consent.
Key exclusion criteria (7 listed)
- Previous ventricular dysfunction (ejection fraction lower than 50%)
- Sustained supraventricular or ventricular arrhythmias;
- Cardiogenic shock or need for inotropes before surgery;
- Immediate need of ventricular assist device or intraaortic balloon after CPB;
- Combined procedure;
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 |
|---|---|---|
| Liberal dobutamine protocolAll patients will receive dobutamine at the cardiopulmonary bypass weaning. | Drug | Liberal dobutamine group |
| Restrictive dobutamine protocolPatients will receive dobutamine during the first 8 hours after cardiopulmonary bypass weaning only if they have a cardiac index of ≤ 2.5L/min/m2 and at least one sign of tissue hypoperfusion: ScvO2 ≤ 70% and / or urine output < 2 mL/Kg/h despite adequate fluid replacement. | Drug | Restrictive dobutamine group |
Primary outcome
Combined endpoint of arrhythmias (ventricular and supraventricular), acute myocardial infarction, stroke or transient ischemic attack, low-output syndrome, cardiogenic shock and death from all causes within 30 days after cardiac surgery
Time frame: 30 days
10 secondary outcomes
Mortality rate
Time frame: 30 days
Acute myocardial infarction incidence
Time frame: 30 days
Stroke incidence
Time frame: 30 days
Low cardiac output syndrome
Time frame: 30 days
Cardiogenic shock
Time frame: 30 days
Cardiac arrhythmias
Time frame: 30 days
ICU and hospital length of stay
Time frame: 30 days
Days free of mechanical ventilation
Time frame: 30 days
Severe sepsis and septic shock
Time frame: 30 days
SOFA score within 72 hours
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Derived from this study: PubMed 33496877Franco RA, de Almeida JP, Landoni G, Scheeren TWL, Galas FRBG, Fukushima JT, Zefferino S, Nardelli P, de Albuquerque Piccioni M, Arita ECTC, Park CHL, Cunha LCC, de Oliveira GQ, Costa IBSDS, Kalil Filho R, Jatene FB, Hajjar LA. Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial. Ann Intensive Care. 2021 Jan 26;11(1):15. doi: 10.1186/s13613-021-00808-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Liberal dobutamine protocol and Restrictive dobutamine protocol in people with Cardiac Output, Low and Coronary Disease, run by University of Sao Paulo 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 16 Mar 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined endpoint of arrhythmias (ventricular and supraventricular), acute myocardial infarction, stroke or transient ischemic attack, low-output syndrome, cardiogenic shock and death from all causes within 30 days after cardiac surgery (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361801, which also lists 1 linked publication.
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 16 Mar 2022.