GLS in Difficult CPB Weaning

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

About this trial

The goal of this observational study is to learn whether global longitudinal strain (GLS), measured by echocardiography, can predict difficulty separating from cardiopulmonary bypass (CPB) in adults undergoing elective cardiac surgery.

The main questions it aims to answer are:

* Can preoperative GLS measurement predict difficult separation from CPB? * Are GLS values associated with outcomes such as intensive care unit (ICU) stay, hospital stay, cardiac biomarkers, or 30-day mortality?

Participants will:

* Undergo standard cardiac surgery requiring CPB * Have echocardiographic assessments (TTE before and after surgery) * Have their recovery and outcomes monitored, including ICU and hospital stay, postoperative labs, and survival within 30 days

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years.

Scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CPB).

Provided written informed consent to participate.

Isolated mitral valve replacement or repair.

Disqualifiers

Emergency cardiac surgery.

Redo cardiac surgery.

Contraindications to transesophageal echocardiography (TEE).

Ongoing inotropic drug therapy.

Trial population

Adult patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass at participating tertiary cardiac surgery centers. The study recruits participants from routine surgical practice in academic and high-volume referral hospitals, where both valve and coronary artery procedures are performed. Consecutive eligible patients who provide informed consent are enrolled prospectively.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Myocardial strain imaging

    Diagnostic test

    Two-dimensional strain analysis was performed using frame-by-frame tracking of unique patterns of bright and dark pixels in grayscale (B-mode) sector images to assess myocardial deformation. The frame rate was maintained between 40 and 90 Hz. The myocardium in each image was divided into six myocardial segments, which were individually assessed for tracking quality. GLS was calculated as the average strain value of 18 myocardial segments obtained from the three echocardiographic views. Patients were included in the final analysis if at least 15 out of 18 segments were considered acceptable for strain measurement by the investigator.

Treatment groups

213 Participants
are divided into 2 treatment groups
Group A: Easy CPB Separation1 intervention
Group B: Difficult CPB Separation1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the predictive value of GLS measurements for difficult separation from cardiopulmonary bypass.

Separating from CPB was categorized as easy and difficult separation from CPB. Easy separation from CPB was defined as no pharmacologic support or use of a single agent (either vasoactive or inotropic). Difficult CPB separation can be defined as the need of at least 2 inotropes or vasopressors to successfully accomplish the separation from CPB

Time frame
perioperative

Secondary outcomes

1

To assess the associations between strain imaging and ICU/hospital length of stay, postoperative trajectories of cardiac biomarkers, and all-cause mortality.

Time frame
Post operative 30 days

Other outcomes

Sponsors and contacts

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Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Lead sponsor

University of Rome Tor Vergata

Collaborator

San Raffaele University Hospital, Italy

Collaborator