Cardiopulmonary BypassNCT07390903
GLS in Difficult CPB Weaning
An observational study of Cardiopulmonary Bypass and Coronary Artery Bypass, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Bypass, Coronary Artery Bypass, Heart Valve Diseases
- What is being tested?
- Myocardial strain imaging
- How many people
- 213 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Feb 2026to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 10Show fewer
- Isolated coronary artery bypass grafting (CABG).
- Combined valve and CABG surgery.
- Multiple valve replacement or repair.
- Surgery involving the ascending aorta or aortic arch.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
University of Rome Tor Vergata
Rome
Valentina Ajello, +39 06 7259 3099, rettore@uniroma2.it
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Istanbul
Mustafa E Gurcu, +905058917800, emregurcu@gmail.com
About this study
Official title: Global Longitudinal Strain as a Predictor of Difficult Separating From Cardiopulmonary Bypass
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:
Read more
- 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
Read the detailed description
Background and Rationale
Difficult separation from cardiopulmonary bypass (CPB) is a serious intraoperative complication associated with increased perioperative morbidity and mortality. Myocardial contractility is the key determinant of successful CPB separation, and perioperative echocardiography is an established method for evaluating ventricular function. Conventionally, left ventricular ejection fraction (LVEF) measured by Simpson's biplane method is used to assess myocardial performance. However, LVEF has notable limitations, including high inter-operator variability, preload/afterload dependence, and poor sensitivity in detecting early myocardial dysfunction.
Global longitudinal strain (GLS), measured by two-dimensional speckle-tracking echocardiography, has emerged as a sensitive, reproducible, and geometry-independent parameter of myocardial function. GLS can detect subtle ventricular dysfunction earlier than conventional LVEF and has demonstrated prognostic value in a variety of clinical settings. Despite this, its use in the perioperative cardiac surgery population remains limited, partly due to uncertainty about the optimal timing of assessment. Anesthesia induction, CPB, and myocardial protection strategies may alter myocardial performance, and therefore both absolute GLS values and dynamic perioperative changes may carry prognostic significance.
Study Objectives
The primary objective of this prospective, multicenter, observational study is to evaluate the predictive value of GLS measurements for difficult separation from CPB. Specifically, the study will assess whether GLS measured by preoperative transthoracic echocardiography (TTE) can independently predict the need for multiple inotropic/vasoactive agents during CPB weaning.
Secondary objectives include exploring the associations between GLS parameters and postoperative outcomes such as intensive care unit (ICU) and hospital length of stay, postoperative changes in cardiac biomarkers, and all-cause 30-day mortality.
Methods
Eligible patients are adults (>18 years) scheduled for elective cardiac surgery requiring CPB, including isolated valve replacement or repair, coronary artery bypass grafting (CABG), combined procedures, and ascending aortic/arch surgery. Patients undergoing emergency or redo surgery, those with contraindications to TEE, or in critical preoperative states (mechanical circulatory support, inotrope dependence, atrial fibrillation, or mechanical ventilation) are excluded.
Echocardiographic assessments are performed at standardized time points: preoperative TTE (T1), intraoperative TEE after induction (T2, if performed), before CPB initiation (T3), immediately after CPB weaning (T4), and following sternal closure (T5). Intraoperative TEE is not mandated by the protocol but may be performed according to institutional practice or operator discretion. GLS analysis follows American Society of Echocardiography (ASE) guidelines, averaging strain from 18 myocardial segments.
Anesthetic and surgical protocols follow institutional standards, with cardioplegia delivered via Buckberg's or del Nido solutions. Clinical, intraoperative, and postoperative data-including operative times, need for pharmacologic support, and recovery variables-are collected systematically by trained staff.
Outcomes
- Primary Endpoint: Ability of GLS value to predict difficult CPB separation, defined as the need for at least two vasoactive or inotropic agents.
- Secondary Endpoints: Association of GLS with ICU/hospital length of stay, postoperative biomarker trends, hospital readmission, and all-cause mortality within 30 days.
Significance
This study addresses a clinically important knowledge gap by evaluating the GLS as a novel predictor of intraoperative difficulty and adverse outcomes in cardiac surgery. If validated, GLS assessment could enhance perioperative risk stratification, guide intraoperative decision-making, and ultimately improve patient outcomes.
- Conditions
- Cardiopulmonary Bypass, Coronary Artery Bypass, Heart Valve Diseases, Echocardiography, Intraoperative Complications, Postoperative Complications (Cardiopulmonary)
- Being tested
- Myocardial strain imaging
- Medical subject headings
- Heart Valve Diseases, Intraoperative Complications, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial strain imagingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Easy CPB Separation | Easy separation from CPB was defined as no pharmacologic support or use of a single agent (either vasoactive or inotropic). Receives: 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. Receives: Diagnostic Test: Myocardial strain imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Post operative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start5 Feb 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Collaborators
- University of Rome Tor Vergata, San Raffaele University Hospital, Italy
- Responsible party
- Principal investigator, mustafa emre gürcü, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390903
- Sponsor's protocol ID
- 2025/14/1189
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32276758Benson 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.
PubMed 31919005Sonny 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.
PubMed 29200066Chan 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.
PubMed 34795909Denault 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.
PubMed 22578975
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Longitudinal Strain as a Predictor of Difficult Separating From Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT07390903
- Acronym / sponsor ID
- 2025/14/1189
- Conditions
- Cardiopulmonary Bypass, Coronary Artery Bypass, Heart Valve Diseases, Echocardiography, Intraoperative Complications, Postoperative Complications (Cardiopulmonary)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Collaborators
- University of Rome Tor Vergata, San Raffaele University Hospital, Italy
- Study start
- 5 Feb 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Background and Rationale
Difficult separation from cardiopulmonary bypass (CPB) is a serious intraoperative complication associated with increased perioperative morbidity and mortality. Myocardial contractility is the key determinant of successful CPB separation, and perioperative echocardiography is an established method for evaluating ventricular function. Conventionally, left ventricular ejection fraction (LVEF) measured by Simpson's biplane method is used to assess myocardial performance. However, LVEF has notable limitations, including high inter-operator variability, preload/afterload dependence, and poor sensitivity in detecting early myocardial dysfunction.
Global longitudinal strain (GLS), measured by two-dimensional speckle-tracking echocardiography, has emerged as a sensitive, reproducible, and geometry-independent parameter of myocardial function. GLS can detect subtle ventricular dysfunction earlier than conventional LVEF and has demonstrated prognostic value in a variety of clinical settings. Despite this, its use in the perioperative cardiac surgery population remains limited, partly due to uncertainty about the optimal timing of assessment. Anesthesia induction, CPB, and myocardial protection strategies may alter myocardial performance, and therefore both absolute GLS values and dynamic perioperative changes may carry prognostic significance.
Study Objectives
The primary objective of this prospective, multicenter, observational study is to evaluate the predictive value of GLS measurements for difficult separation from CPB. Specifically, the study will assess whether GLS measured by preoperative transthoracic echocardiography (TTE) can independently predict the need for multiple inotropic/vasoactive agents during CPB weaning.
Secondary objectives include exploring the associations between GLS parameters and postoperative outcomes such as intensive care unit (ICU) and hospital length of stay, postoperative changes in cardiac biomarkers, and all-cause 30-day mortality.
Methods
Eligible patients are adults (>18 years) scheduled for elective cardiac surgery requiring CPB, including isolated valve replacement or repair, coronary artery bypass grafting (CABG), combined procedures, and ascending aortic/arch surgery. Patients undergoing emergency or redo surgery, those with contraindications to TEE, or in critical preoperative states (mechanical circulatory support, inotrope dependence, atrial fibrillation, or mechanical ventilation) are excluded.
Echocardiographic assessments are performed at standardized time points: preoperative TTE (T1), intraoperative TEE after induction (T2, if performed), before CPB initiation (T3), immediately after CPB weaning (T4), and following sternal closure (T5). Intraoperative TEE is not mandated by the protocol but may be performed according to institutional practice or operator discretion. GLS analysis follows American Society of Echocardiography (ASE) guidelines, averaging strain from 18 myocardial segments.
Anesthetic and surgical protocols follow institutional standards, with cardioplegia delivered via Buckberg's or del Nido solutions. Clinical, intraoperative, and postoperative data-including operative times, need for pharmacologic support, and recovery variables-are collected systematically by trained staff.
Outcomes
- Primary Endpoint: Ability of GLS value to predict difficult CPB separation, defined as the need for at least two vasoactive or inotropic agents.
- Secondary Endpoints: Association of GLS with ICU/hospital length of stay, postoperative biomarker trends, hospital readmission, and all-cause mortality within 30 days.
Significance
This study addresses a clinically important knowledge gap by evaluating the GLS as a novel predictor of intraoperative difficulty and adverse outcomes in cardiac surgery. If validated, GLS assessment could enhance perioperative risk stratification, guide intraoperative decision-making, and ultimately improve patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Easy CPB Separation | – | Diagnostic Test: Myocardial strain imagingEasy separation from CPB was defined as no pharmacologic support or use of a single agent (either vasoactive or inotropic). |
| Difficult CPB Separation | – | Diagnostic Test: Myocardial strain imagingDifficult CPB separation can be defined as the need of at least 2 inotropes or vasopressors to successfully accomplish the separation from CPB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Age > 18 years.
- Scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CPB).
- Provided written informed consent to participate.
- Eligible surgical procedures include:
Key exclusion criteria (8 listed)
- Emergency cardiac surgery.
- Redo cardiac surgery.
- Contraindications to transesophageal echocardiography (TEE).
- Critical preoperative conditions, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myocardial strain imagingTwo-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. | Diagnostic test | Difficult CPB Separation, Easy CPB Separation |
Primary outcome
To evaluate the predictive value of GLS measurements for difficult separation from cardiopulmonary bypass.
Time frame: perioperative
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 32276758Monaco 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.
- Background: PubMed 31919005Benson 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.
- Background: PubMed 29200066Sonny 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.
- Background: PubMed 34795909Chan 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.
- Background: PubMed 22578975Denault 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Bypass and Coronary Artery Bypass, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustafa E Gurcu, MD (+905058917800, emregurcu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the predictive value of GLS measurements for difficult separation from cardiopulmonary bypass. (time frame: perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07390903, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.