Perioperative Blood Pressure and In-hospital Morbidity After Coronary Artery Bypass Surgery (PA_PAC)

February 21, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

The prevalence of hypertension is high, estimated at 80% in patients with cardiovascular (CV) disease. The optimal blood pressure (BP) level for CV prevention remains controversial. Data from the literature highlight that the relationship between BP level and mortality is not linear, but rather J-shaped. In particular, in treated hypertensive patients with stable coronary artery disease, a systolic BP below 120 mm Hg is associated with the risk of recurrent coronary events and CV mortality.

An inverse relationship was recently demonstrated between BP level before revascularization procedure and mortality at 3 months and 1 year after the procedure in patients managed for critical ischemia. These data underline the need for a personalized approach to the management of hypertension, especially in elderly hypertensive patients with comorbidities.

The question of the optimal mean BP value also arises in cardiac surgery, especially during extracorporeal circulation in patients undergoing coronary artery bypass grafting. Hypotension during cardiac surgery appears to be associated with renal failure and perioperative mortality in some patients. Conversely, high blood pressure levels (above the cerebral autoregulatory threshold) may be associated with postoperative cognitive impairment and bleeding risk. In hypertensive patients, the autoregulatory capacity of cerebral and renal perfusion is partly impaired, with a greater susceptibility to ischemia in case of hypotension. Personalized blood pressure targets could be beneficial perioperatively with a lower risk of postoperative complications.

The objective of this protocol is to determine a correlation between perioperative mean arterial pressure level and in-hospital morbidity in a population of patients with ischemic heart disease managed for coronary artery bypass grafting (CABG). The results of this descriptive work would make it possible to introduce the problem of the optimal blood pressure target during extracorporeal circulation according to the existence of peripheral arterial damage and preoperative blood pressure values.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1220

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ischemic heart disease managed for coronary artery bypass grafting in the cardiac surgery department at Marie Lannelongue Hospital between 01/01/2016 and 12/31/2020.

Description

Inclusion Criteria:

  • Patient whose age ≥ 18 years
  • Patient with ischemic heart disease managed for coronary artery bypass grafting (CABG) between 01/01/2016 and 12/31/2020
  • French-speaking patient

Exclusion Criteria:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his data for this research

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: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between perioperative mean arterial pressure level in the occurrence of postoperative organ failure
Time Frame: Day 30
This outcome corresponds to the correlation between preoperative and intraoperative mean arterial pressure levels and the occurrence of postoperative organ failure (composite endpoint).
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between perioperative mean arterial pressure level and occurrence of postoperative organ failure
Time Frame: Day 30
This outcome corresponds to the correlation between preoperative and intraoperative mean arterial pressure levels and the occurrence of organ failure.
Day 30

Collaborators and Investigators

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

Sponsor

Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

April 15, 2023

Primary Completion (Anticipated)

December 15, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 30, 2021

First Submitted That Met QC Criteria

December 30, 2021

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA_PAC

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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