Assessment of Cardiac Function and Anesthesia Depth in Patients Undergoing Cardiac Surgery

NCT07770269 | Recruiting

• 1 other identifier: SHAPE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The SHAPE study is a prospective, randomized study evaluating changes in cardiac function in adult patients undergoing cardiac surgery with cardiopulmonary bypass. The study focuses on how cardiac function changes during surgery and whether the depth of anesthesia may influence these changes. Participants are randomly assigned to one of two levels of anesthesia depth, guided by the Bispectral Index (BIS). Cardiac function is assessed using transthoracic echocardiography, including myocardial deformation (strain) imaging and myocardial work measurements. Invasive hemodynamic measurements obtained during surgery are also recorded. The primary objective is to assess the change in left ventricular global longitudinal strain (LV GLS) between two intraoperative time points: after induction of anesthesia and before cardiopulmonary bypass, and after separation from cardiopulmonary bypass. The study will also examine whether these changes differ according to the assigned depth of anesthesia and whether echocardiographic and hemodynamic measurements are associated with postoperative outcomes. Participants will also undergo follow-up echocardiographic assessment at 3, 6, and 12 months after surgery to evaluate longer-term changes in cardiac function.

Conditions

Heart Disease

Keywords

Cardiac Surgery; Cardiopulmonary Bypass; Global Longitudinal Strain; Myocardial Work; Speckle-Tracking Echocardiography; Bispectral Index; Depth of Anesthesia; Hemodynamic Monitoring; Swan-Ganz Catheter; Low Cardiac Output Syndrome

Outcome Measures

Primary Outcomes (1)

• Within-Participant Change in Left Ventricular Global Longitudinal Strain (LV GLS) From T1 to T2

  Left ventricular global longitudinal strain (LV GLS) will be assessed by speckle-tracking echocardiography at two predefined intraoperative time points: T1, after induction of anesthesia and before initiation of cardiopulmonary bypass, and T2, after separation from cardiopulmonary bypass. The primary outcome will be the within-participant change in LV GLS, calculated as T2 minus T1 and expressed in percentage points. Because LV GLS is expressed as a negative value, a positive T2-minus-T1 difference indicates a reduction in the absolute magnitude of LV GLS and therefore deterioration in longitudinal systolic function.

  During index cardiac surgery: T1 after induction of anesthesia and before cardiopulmonary bypass; T2 after separation from cardiopulmonary bypass.

Secondary Outcomes (27)

• Change in Left Ventricular Global Longitudinal Strain (LV GLS) From T1 to T2 by Randomized BIS Group

  During index cardiac surgery: from T1 before cardiopulmonary bypass to T2 after separation from cardiopulmonary bypass.

• Change in Left Ventricular Myocardial Work Indices From T1 to T2 by Randomized BIS Group

  During index cardiac surgery: from T1, before cardiopulmonary bypass, to T2, after separation from cardiopulmonary bypass.

• Postoperative Adverse Clinical Events

  From completion of index cardiac surgery through discharge during the index hospitalization, assessed up to 60 days after surgery.

• Duration of Mechanical Ventilation

  From completion of index cardiac surgery until successful extubation during the index hospitalization, assessed up to 60 days after surgery.

• Length of Intensive Care Unit Stay

  From postoperative ICU admission until ICU discharge during the index hospitalization, assessed up to 60 days after surgery.

Study Arms (2)

BIS 45-55

ACTIVE COMPARATOR

Participants assigned to this arm will receive total intravenous anesthesia with propofol and remifentanil, adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 45-55, representing standard anesthesia depth.

Other: BIS-guided anesthesia: BIS 45-55

BIS 30-35

EXPERIMENTAL

Participants assigned to this arm will receive total intravenous anesthesia with propofol and remifentanil, adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 30-35, representing deeper anesthesia.

Other: BIS-guided anesthesia: BIS 30-35

Interventions

BIS-guided anesthesia: BIS 45-55 OTHER

Total intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 45-55, representing standard anesthesia depth.

BIS 45-55

BIS-guided anesthesia: BIS 30-35 OTHER

Total intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 30-35, representing deeper anesthesia.

BIS 30-35

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older, irrespective of sex.
• Scheduled to undergo elective cardiac surgery involving cardiopulmonary bypass (on-pump surgery).
• Anticipated adequate acoustic window for transthoracic echocardiography.
• Provision of written informed consent.

You may not qualify if:

• \- Emergency or unscheduled cardiac surgery.
• Cardiac surgery without cardiopulmonary bypass (off-pump surgery).
• Refusal or inability to provide written informed consent.

Sponsors & Collaborators

• AHEPA University Hospital: lead

Study Sites (1)

AHEPA University General Hospital of Thessaloniki

Thessaloniki, 54636, Greece

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Cardiac Output, Low

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vasileios Kamperidis, Assistant Professor

  1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece

  STUDY CHAIR

• Despoina Sarridou, Associate Professor

  Department of Anesthesiology, AHEPA University Hospital, Aristotle University of Thessaloniki

  STUDY DIRECTOR

• Helena Argiriadou, Professor

  Department of Anesthesiology and Intensive Care, AHEPA University Hospital, Aristotle University of Thessaloniki

  STUDY DIRECTOR

• Antonios Ziakas, Professor

  1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece

  STUDY DIRECTOR

• Christos Mantzios, Cardiology Resident, MD, MSc

  1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christos Mantzios, Cardiology Resident, MD, MSc

CONTACT

+306983282188; chrismantzios1994@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The echocardiographic outcome assessor remains blinded to treatment allocation during image acquisition, offline echocardiographic analysis, and primary outcome assessment.The treating anesthesiologist is not masked because knowledge of the assigned BIS target is required to administer the intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Resident, First Department of Cardiology, AHEPA University General Hospital of Thessaloniki

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 18, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)