Beta Blocker Use in Cardiac Surgery and Association With Postoperative Course

NCT04769752 | Completed

• 1 other identifier: Guinot 2021
• Study Type: observational
• Target: 1,789
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery With Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

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

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

  7 days

Study Arms (3)

No beta-blocker

Patient do no treat with beta-blocker before the surgery

Other: collection of the allocated treatment; Other: collection of medical complications

Beta blocker

Patient treat with beta-blocker in accordance to international guidelines

Other: collection of the allocated treatment; Other: collection of medical complications

Beta blocker2

Patient treat with beta-blocker without respect of international guidelines

Interventions

collection of the allocated treatment OTHER

collection of the allocated treatment

Beta blocker; No beta-blocker

collection of medical complications OTHER

collection of medical complications

Beta blocker; No beta-blocker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Major patient ≥ 18 years
• Patient operated cardiac surgery with cardiopulmonary bypass
• Patients who have given oral consent to participate after full information

You may not qualify if:

• Off pump cardiac surgery

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Related Publications (1)

• 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.

  PMID: 38789363 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 24, 2021
• Study Start: June 1, 2020
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: February 16, 2024

Record last verified: 2023-02

Locations

FR (1)