Cardiac Surgery With Cardiopulmonary BypassBLOCKNCT04769752
Beta Blocker Use in Cardiac Surgery and Association With Postoperative Course
An observational study of Cardiac Surgery With Cardiopulmonary Bypass, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The objective of this study is to describe in a cohort of cardiac surgery patients the use of beta-blockers before surgery and their maintenance or withdraw according to international recommendations in order to compare patients who receive a beta-blocker with maintenance during the surgical period (international… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery With Cardiopulmonary Bypass
- What is being tested?
- collection of the allocated treatment and collection of medical complications
- How many people
- 1,789 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2020to 22 Dec 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: All consecutive cardiac surgical patients who meeet inclusion criteria with cardiopulmonary bypass
Who may be able to join
- Major patient ≥ 18 years
- Patient operated cardiac surgery with cardiopulmonary bypass
- Patients who have given oral consent to participate after full information
Who cannot join
- Off pump cardiac surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use and Prescription of Beta-blockers Before Cardiac Surgery With Cardiopulmopnary Bypass: Multicenter Observational Analysis of Practices and Its Association With Postoperative Morbidity-mortality.
The objective of this study is to describe in a cohort of cardiac surgery patients the use of beta-blockers before surgery and their maintenance or withdraw according to international recommendations in order to compare patients who receive a beta-blocker with maintenance during the surgical period (international recommendation) to those for whom prescription and maintenance are not respected. Patients are treated according to standard practice and this protocol does not change patient management. No additional information or data is required by the study other than the data usually collected in the patient record (drug treatment, medical history, operating data, postoperative data, complications, length of stay).
The objectives of this research are :
- To evaluate the proportion of patients receiving beta-blocker treatment prior to cardiac surgery.
- To evaluate the proportion of patients receiving beta-blocker treatment before cardiac surgery and complying with international recommendations for its maintenance/stop in perioperative cardiac surgery.
- To evaluate the incidence of complications and length of hospital stay in patients receiving beta-blockers based on compliance or non-compliance with recommendations.
- Being tested
- collection of the allocated treatment, collection of medical complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of the allocated treatmentOther
collection of the allocated treatment
collection of medical complicationsOther
collection of medical complications
| Study group | Role | What they receive |
|---|---|---|
| No beta-blocker | Patient do no treat with beta-blocker before the surgery Receives: Other: collection of the allocated treatment; Other: collection of medical complications | |
| Beta blocker | Patient treat with beta-blocker in accordance to international guidelines Receives: Other: collection of the allocated treatment; Other: collection of medical complications | |
| Beta blocker2 | Patient treat with beta-blocker without respect of international guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated with beta-blocker in accordance with international guidelines
Number of patients treated with beta-blocker in accordance with international guidelines
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study startJun 2020
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
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 Surgery With Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,789 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769752
- Sponsor's protocol ID
- Guinot 2021
- Acronym
- BLOCK
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2021
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guinot PG, Fischer MO, Nguyen M, Berthoud V, Decros JB, Besch G, Bouhemad B. Maintenance of beta-blockers and cardiac surgery-related outcomes: a prospective propensity-matched multicentre analysis. Br J Anaesth. 2024 Aug;133(2):288-295. doi: 10.1016/j.bja.2024.04.018. Epub 2024 May 23.
PubMed 38789363
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Prescription of Beta-blockers Before Cardiac Surgery With Cardiopulmopnary Bypass: Multicenter Observational Analysis of Practices and Its Association With Postoperative Morbidity-mortality.
- ClinicalTrials.gov ID
- NCT04769752
- Acronym / sponsor ID
- BLOCK / Guinot 2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,789 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jun 2020 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 24 Feb 2021 (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.
The objective of this study is to describe in a cohort of cardiac surgery patients the use of beta-blockers before surgery and their maintenance or withdraw according to international recommendations in order to compare patients who receive a beta-blocker with maintenance during the surgical period (international recommendation) to those for whom prescription and maintenance are not respected. Patients are treated according to standard practice and this protocol does not change patient management. No additional information or data is required by the study other than the data usually collected in the patient record (drug treatment, medical history, operating data, postoperative data, complications, length of stay).
The objectives of this research are :
- To evaluate the proportion of patients receiving beta-blocker treatment prior to cardiac surgery.
- To evaluate the proportion of patients receiving beta-blocker treatment before cardiac surgery and complying with international recommendations for its maintenance/stop in perioperative cardiac surgery.
- To evaluate the incidence of complications and length of hospital stay in patients receiving beta-blockers based on compliance or non-compliance with recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No beta-blocker | – | Other: collection of the allocated treatment, Other: collection of medical complicationsPatient do no treat with beta-blocker before the surgery |
| Beta blocker | – | Other: collection of the allocated treatment, Other: collection of medical complicationsPatient treat with beta-blocker in accordance to international guidelines |
| Beta blocker2 | – | –Patient treat with beta-blocker without respect of international guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive cardiac surgical patients who meeet inclusion criteria with cardiopulmonary bypass
Key inclusion criteria (3 listed)
- Major patient ≥ 18 years
- Patient operated cardiac surgery with cardiopulmonary bypass
- Patients who have given oral consent to participate after full information
Key exclusion criteria (1 listed)
- Off pump cardiac surgery
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 |
|---|---|---|
| collection of the allocated treatmentcollection of the allocated treatment | Other | Beta blocker, No beta-blocker |
| collection of medical complicationscollection of medical complications | Other | Beta blocker, No beta-blocker |
Primary outcome
Number of patients treated with beta-blocker in accordance with international guidelines
Time frame: 7 days
Number of patients treated with beta-blocker in accordance with international guidelines
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 Feb 2024.
- Derived from this study: PubMed 38789363Guinot PG, Fischer MO, Nguyen M, Berthoud V, Decros JB, Besch G, Bouhemad B. Maintenance of beta-blockers and cardiac surgery-related outcomes: a prospective propensity-matched multicentre analysis. Br J Anaesth. 2024 Aug;133(2):288-295. doi: 10.1016/j.bja.2024.04.018. Epub 2024 May 23.
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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?
An observational study of Cardiac Surgery With Cardiopulmonary Bypass, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 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 16 Feb 2024. 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 France. 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.
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?
Number of patients treated with beta-blocker in accordance with international guidelines (time frame: 7 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 NCT04769752, 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 Feb 2024.