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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Unknown status
CT.gov ID
NCT04769752
Collaborator
(none)
2,000
1
15
133.2

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: collection of the allocated treatment
  • Other: collection of medical complications

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Number of patients treated with beta-blocker in accordance with international guidelines [7 days]

    Number of patients treated with beta-blocker in accordance with international guidelines

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourogne Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT04769752
Other Study ID Numbers:
  • Guinot 2021
First Posted:
Feb 24, 2021
Last Update Posted:
Feb 24, 2021
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 24, 2021