GLS in Difficult CPB Weaning

NCT07390903 | Recruiting

• 1 other identifier: 2025/14/1189
• Study Type: observational
• Target: 213
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Postoperative Complications (Cardiopulmonary); Cardiopulmonary Bypass; Coronary Artery Bypass; Heart Valve Diseases; Echocardiography; Intraoperative Complications

Outcome Measures

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

  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.

  Post operative 30 days

Study Arms (2)

Easy CPB Separation

Easy separation from CPB was defined as no pharmacologic support or use of a single agent (either vasoactive or inotropic).

Diagnostic Test: Myocardial strain imaging

Difficult CPB Separation

Difficult CPB separation can be defined as the need of at least 2 inotropes or vasopressors to successfully accomplish the separation from CPB.

Diagnostic Test: Myocardial strain imaging

Interventions

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.

Difficult CPB Separation; Easy CPB Separation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Age \> 18 years.
• Scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CPB).
• Provided written informed consent to participate.
• Eligible surgical procedures include:
• Isolated mitral valve replacement or repair.
• Isolated aortic valve replacement or repair.
• Isolated coronary artery bypass grafting (CABG).
• Combined valve and CABG surgery.
• Multiple valve replacement or repair.
• Surgery involving the ascending aorta or aortic arch.

You may not qualify if:

• Emergency cardiac surgery.
• Redo cardiac surgery.
• Contraindications to transesophageal echocardiography (TEE).
• Critical preoperative conditions, including:
• Ongoing inotropic drug therapy.
• Preoperative mechanical circulatory support (e.g., IABP, ECMO, VAD).
• Requirement for mechanical ventilation.
• Preoperative atrial fibrillation.

Sponsors & Collaborators

• University of Rome Tor Vergata: collaborator
• San Raffaele University Hospital, Italy: collaborator
• Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital: lead

Study Sites (2)

University of Rome Tor Vergata

Rome, Italy

RECRUITING

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Monaco F, Di Prima AL, Kim JH, Plamondon MJ, Yavorovskiy A, Likhvantsev V, Lomivorotov V, Hajjar LA, Landoni G, Riha H, Farag AMGA, Gazivoda G, Silva FS, Lei C, Bradic N, El-Tahan MR, Bukamal NAR, Sun L, Wang CY. Management of Challenging Cardiopulmonary Bypass Separation. J Cardiothorac Vasc Anesth. 2020 Jun;34(6):1622-1635. doi: 10.1053/j.jvca.2020.02.038. Epub 2020 Feb 29.

  PMID: 32276758 BACKGROUND

• Benson MJ, Silverton N, Morrissey C, Zimmerman J. Strain Imaging: An Everyday Tool for the Perioperative Echocardiographer. J Cardiothorac Vasc Anesth. 2020 Oct;34(10):2707-2717. doi: 10.1053/j.jvca.2019.11.035. Epub 2019 Dec 7.

  PMID: 31919005 BACKGROUND

• Sonny A, Alfirevic A, Sale S, Zimmerman NM, You J, Gillinov AM, Sessler DI, Duncan AE. Reduced Left Ventricular Global Longitudinal Strain Predicts Prolonged Hospitalization: A Cohort Analysis of Patients Having Aortic Valve Replacement Surgery. Anesth Analg. 2018 May;126(5):1484-1493. doi: 10.1213/ANE.0000000000002684.

  PMID: 29200066 BACKGROUND

• Chan PG, Seese L, Aranda-Michel E, Sultan I, Gleason TG, Wang Y, Thoma F, Kilic A. Operative mortality in adult cardiac surgery: is the currently utilized definition justified? J Thorac Dis. 2021 Oct;13(10):5582-5591. doi: 10.21037/jtd-20-2213.

  PMID: 34795909 BACKGROUND

• Denault AY, Tardif JC, Mazer CD, Lambert J; BART Investigators. Difficult and complex separation from cardiopulmonary bypass in high-risk cardiac surgical patients: a multicenter study. J Cardiothorac Vasc Anesth. 2012 Aug;26(4):608-16. doi: 10.1053/j.jvca.2012.03.031. Epub 2012 May 11.

  PMID: 22578975 BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases; Intraoperative Complications; Postoperative Complications

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mustafa E Gurcu, MD

CONTACT

+905058917800; emregurcu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Medical Doctor

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 5, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); TU (1)