Cardiac SurgeryPhase 4BREVINCT00959569
Esmolol in Cardiac Surgery
A Phase 4 study testing Esmolol in people with Cardiac Surgery, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Esmolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2009to Jun 2018
- Phase
- Phase 4
- 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
- end diastolic diameter >60 mm and/or an ejection fraction <50%
- written informed consent
- age >18 years
- esmolol administration in the previous 30 days
- emergency operation
Who cannot join
- previous unusual response to esmolol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esmolol in Cardiac Surgery. A Randomized Controlled Trial With Clinical
This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy.
- Conditions
- Cardiac Surgery
- Being tested
- Esmolol, Placebo
- Keywords
- esmolol, cardiac surgery, cardiac anesthesia, mortality, beta blockers, beta-blockers, cardiac protection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
Also called Beta-blocker; Beta blocker; breviblock
esmolol (1-3 mg/kg) during cardiac surgery
PlaceboDrug
normosaline (same ml of the study drug)
| Study group | Role | What they receive |
|---|---|---|
| esmolol | Experimental | the study group will receive esmolol (1-3 mg/kg) Receives: Drug: Esmolol |
| normosaline | Placebo comparator | normosaline (same ml of the study drug) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay.
Measured: Hospital stay (approximately 2 weeks)
Secondary outcomes (4)
Number of patients with ventricular fibrillation after cardiopulmonary bypass
Measured: 30 days and 1 year
Number of patients with low cardiac output syndrome
Measured: 30 days and 1 year
Number of patients requiring post-operative inotropic support
Measured: 30 days and 1 year
peak postoperative cardiac troponin level
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Landoni, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959569
- Sponsor's protocol ID
- GO/URC/ER/mm 459/DG
- Acronym
- BREVI
- Status last verified
- Oct 2018
- First submitted
- 13 Aug 2009
- Last updated
- 10 Oct 2018
- Results posted
- No
Publications
Zangrillo A, Turi S, Crescenzi G, Oriani A, Distaso F, Monaco F, Bignami E, Landoni G. Esmolol reduces perioperative ischemia in cardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):625-32. doi: 10.1053/j.jvca.2009.01.003. Epub 2009 Mar 18.
PubMed 19297196Crescenzi G, Rosica C, Marino G, Serini SM, Covello RD, Landoni G, Zangrillo A. The use of esmolol to treat systolic anterior motion of the mitral valve after mitral valve repair. Eur J Anaesthesiol. 2008 Apr;25(4):342-3. doi: 10.1017/S0265021507002876. No abstract available.
PubMed 18334040Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. doi: 10.2174/138945009789108837. Epub 2009 Sep 1.
PubMed 19538174Crescenzi G, Landoni G, Zangrillo A, Guarracino F, Rosica C, La Canna G, Alfieri O. Management and decision-making strategy for systolic anterior motion after mitral valve repair. J Thorac Cardiovasc Surg. 2009 Feb;137(2):320-5. doi: 10.1016/j.jtcvs.2008.08.018.
PubMed 19185145
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esmolol in Cardiac Surgery. A Randomized Controlled Trial With Clinical
- ClinicalTrials.gov ID
- NCT00959569
- Acronym / sponsor ID
- BREVI / GO/URC/ER/mm 459/DG
- Conditions
- Cardiac Surgery
- Keywords
- esmolol, cardiac surgery, cardiac anesthesia, mortality, beta blockers, beta-blockers, cardiac protection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 14 Aug 2009 (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.
This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esmolol | Experimental | Drug: Esmololthe study group will receive esmolol (1-3 mg/kg) |
| normosaline | Placebo comparator | Drug: Placebonormosaline (same ml of the study drug) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- end diastolic diameter >60 mm and/or an ejection fraction <50%
- written informed consent
- age >18 years
- esmolol administration in the previous 30 days
- emergency operation
Key exclusion criteria (1 listed)
- previous unusual response to esmolol
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 |
|---|---|---|
| EsmololAlso: Beta-blocker; Beta blocker; breviblockesmolol (1-3 mg/kg) during cardiac surgery | Drug | esmolol |
| Placebonormosaline (same ml of the study drug) | Drug | normosaline |
Primary outcome
Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay.
Time frame: Hospital stay (approximately 2 weeks)
4 secondary outcomes
Number of patients with ventricular fibrillation after cardiopulmonary bypass
Time frame: 30 days and 1 year
Number of patients with low cardiac output syndrome
Time frame: 30 days and 1 year
Number of patients requiring post-operative inotropic support
Time frame: 30 days and 1 year
peak postoperative cardiac troponin level
Time frame: 30 days and 1 year
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 10 Oct 2018.
- Background: PubMed 19297196Zangrillo A, Turi S, Crescenzi G, Oriani A, Distaso F, Monaco F, Bignami E, Landoni G. Esmolol reduces perioperative ischemia in cardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):625-32. doi: 10.1053/j.jvca.2009.01.003. Epub 2009 Mar 18.
- Background: PubMed 18334040Crescenzi G, Rosica C, Marino G, Serini SM, Covello RD, Landoni G, Zangrillo A. The use of esmolol to treat systolic anterior motion of the mitral valve after mitral valve repair. Eur J Anaesthesiol. 2008 Apr;25(4):342-3. doi: 10.1017/S0265021507002876. No abstract available.
- Background: PubMed 19538174Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. doi: 10.2174/138945009789108837. Epub 2009 Sep 1.
- Background: PubMed 19185145Crescenzi G, Landoni G, Zangrillo A, Guarracino F, Rosica C, La Canna G, Alfieri O. Management and decision-making strategy for systolic anterior motion after mitral valve repair. J Thorac Cardiovasc Surg. 2009 Feb;137(2):320-5. doi: 10.1016/j.jtcvs.2008.08.018.
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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 4 study testing Esmolol in people with Cardiac Surgery, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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 5 inclusion and 1 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 10 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay. (time frame: Hospital stay (approximately 2 weeks)). 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 NCT00959569, which also lists 4 linked publications.
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 10 Oct 2018.