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RecruitingNCT07926360ClinicalTrials.gov record

Cardiac Cycle Efficiency and Vasoactive-Inotropic Support After Cardiac Surgery

Cardiac Surgical Procedures · Low Cardiac Output Syndrome

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Observational
Phase
Not applicable / not listed
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
68 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This study aims to find out whether Cardiac Cycle Efficiency (CCE), measured with the MostCare Up monitor 30 minutes after coming off cardiopulmonary bypass, can predict which adult patients will need high doses of vasoactive and inotropic drugs (maximum Vasoactive-Inotropic Score ≥15) in the first 24 hours after open-heart surgery. No additional procedures or treatments will be applied; data will be collected from the routinely placed arterial catheter.

Read the full description

After open-heart surgery with cardiopulmonary bypass (CPB), many patients develop myocardial depression and vasoplegia and require vasoactive and inotropic support. High support requirement, quantified by the Vasoactive-Inotropic Score (VIS), is associated with prolonged mechanical ventilation, acute kidney injury, longer ICU stay and increased mortality. Reliable early hemodynamic markers to identify these patients are lacking.

Cardiac Cycle Efficiency (CCE), derived from arterial waveform analysis by the Pressure Recording Analytical Method (MostCare Up), reflects the energetic efficiency of the cardiovascular system, integrating contractility, arterial load and ventricular-arterial coupling. Lower CCE values have been associated with higher inotropic requirement in children after cardiac surgery, but data in adults are lacking.

In this single-center prospective observational study, hemodynamic parameters will be recorded at six time points: after induction, before CPB, 15 and 30 minutes after separation from CPB, end of surgery, and ICU admission. Patients will be classified according to maximum VIS in the first 24 postoperative hours (\<15 vs ≥15). The predictive performance of CCE at 30 minutes after CPB will be assessed by ROC analysis. Associations of CCE with lactate, duration of mechanical ventilation, ICU and hospital stay, acute kidney injury and in-hospital mortality will also be evaluated.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • Age 18 years or older
  • ASA physical status II-IV
  • Elective coronary artery bypass grafting, valve surgery, or combined CABG and valve surgery with cardiopulmonary bypass
  • Written informed consent

Exclusion Criteria:

  • Emergency surgery
  • Preoperative mechanical circulatory support (IABP, ECMO, Impella, etc.)
  • Permanent pacemaker dependency
  • Severe arrhythmia (uncontrolled atrial fibrillation, ventricular arrhythmia, etc.)
  • Redo cardiac surgery
  • Aortic dissection
  • Pregnancy
  • Unreliable arterial pressure waveform
  • Need for IABP, ECMO, or temporary epicardial pacing during weaning from bypass or during surgery

Study population

Adult patients undergoing elective open-heart surgery with cardiopulmonary bypass at Bursa City Hospital.

Understand screening

Treatment, groups and participation

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Assignment
Not reported
Masking
Not reported
Adult Open-Heart Surgery Patients

Adult patients undergoing elective coronary artery bypass grafting, valve surgery, or combined surgery with cardiopulmonary bypass. Hemodynamic parameters including Cardiac Cycle Efficiency will be recorded with the MostCare Up system via the routinely placed radial arterial catheter. No study-specific intervention will be applied.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Predictive Performance of CCE for High Vasoactive-Inotropic Support

Time frame: First 24 hours after ICU admission

Area under the ROC curve of Cardiac Cycle Efficiency measured 30 minutes after separation from cardiopulmonary bypass for predicting maximum Vasoactive-Inotropic Score (VISmax) ≥15. VISmax is the highest hourly VIS during the first 24 hours after ICU admission.

Secondary measures

Predictive Performance of Early CCE (T3 and Mean T3-T4)

Time frame: First 24 hours after ICU admission

ROC analysis of CCE at 15 minutes after bypass and mean of 15- and 30-minute CCE values for predicting VISmax ≥15.

Vasoactive-Inotropic Score

Time frame: At intensive care unit admission and 6 and 24 hours after admission.

The Vasoactive-Inotropic Score (VIS) will be assessed at intensive care unit admission and at 6 and 24 hours after admission. VIS will be calculated as dopamine + dobutamine + (100 × epinephrine) + (100 × norepinephrine) + (50 × levosimendan) + (10,000 × vasopressin). Drug doses are expressed in µg/kg/min, except vasopressin, which is expressed in units/kg/min. The minimum score is 0, and there is no fixed maximum score. Higher scores indicate worse outcomes, reflecting greater vasoactive and inotropic support requirements; lower scores indicate better outcomes, reflecting lower support requirements.

Serum Lactate and Lactate Clearance

Time frame: 24 hours

Lactate (mmol/L) at ICU admission, 6 and 24 hours; lactate clearance in the first 6 hours (%).

In-Hospital Mortality

Time frame: Until hospital discharge, up to 30 days

All-cause death during hospital stay.

Duration of Mechanical Ventilation

Time frame: Until hospital discharge, up to 30 days

Time from ICU admission to extubation (hours) and need for reintubation.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

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1 locations

Bursa City HospitalNilufer, Bursa, Turkey (Türkiye)Recruiting

Study team and timeline

Lead sponsor
Bursa City Hospital
Study start
Nov 1, 2026 Actual
Primary completion
Jan 15, 2027 Estimated
Study completion
Jan 15, 2027 Estimated
First posted
Nov 9, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

The Value of Cardiac Cycle Efficiency After Cardiopulmonary Bypass in Predicting Vasoactive-Inotropic Support Requirement (VIS) in the First 24 Hours in Open-Heart Surgery: A Prospective Observational Cohort Study

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026