Beta Blocker Use in Cardiac Surgery and Association With Postoperative Course (BLOCK)

February 15, 2024 updated by: Centre Hospitalier Universitaire Dijon

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1789

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • Chu Dijon Bourogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All consecutive cardiac surgical patients who meeet inclusion criteria with cardiopulmonary bypass

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: collection of the allocated treatment
collection of the allocated treatment
Other: collection of medical complications
collection of medical complications
Beta blocker
Patient treat with beta-blocker in accordance to international guidelines
Other: collection of the allocated treatment
collection of the allocated treatment
Other: collection of medical complications
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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

December 22, 2023

Study Completion (Actual)

December 22, 2023

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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