- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04769752
Beta Blocker Use in Cardiac Surgery and Association With Postoperative Course (BLOCK)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Dijon, France, 21000
- Chu Dijon Bourogne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Major patient ≥ 18 years
- Patient operated cardiac surgery with cardiopulmonary bypass
- Patients who have given oral consent to participate after full information
Exclusion Criteria:
- Off pump cardiac surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
No beta-blocker
Patient do no treat with beta-blocker before the surgery
|
collection of the allocated treatment
collection of medical complications
|
|
Beta blocker
Patient treat with beta-blocker in accordance to international guidelines
|
collection of the allocated treatment
collection of medical complications
|
|
Beta blocker2
Patient treat with beta-blocker without respect of international guidelines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
7 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Guinot 2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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