An observational study in Cardiac Surgical Procedures and Low Cardiac Output Syndrome, sponsored by Bursa City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Bursa City Hospital · Observational
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.
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.
99 studies on the registry are indexed under Cardiac Output, Low; 15 are open to participants now.
This study's planned enrollment of 68 is close to the median of 66 across 48 observational studies indexed under Cardiac Output, Low.
Browse Cardiac Output, Low studies →Bursa City Hospital is the lead sponsor of 71 studies on the registry; 31 are open to participants now.
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Adult patients undergoing elective open-heart surgery with cardiopulmonary bypass at Bursa City Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Predictive Performance of CCE for High Vasoactive-Inotropic Support
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.
Time frame: First 24 hours after ICU admission
Predictive Performance of Early CCE (T3 and Mean T3-T4)
ROC analysis of CCE at 15 minutes after bypass and mean of 15- and 30-minute CCE values for predicting VISmax ≥15.
Time frame: First 24 hours after ICU admission
Vasoactive-Inotropic Score
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.
Time frame: At intensive care unit admission and 6 and 24 hours after admission.
Serum Lactate and Lactate Clearance
Lactate (mmol/L) at ICU admission, 6 and 24 hours; lactate clearance in the first 6 hours (%).
Time frame: 24 hours
In-Hospital Mortality
All-cause death during hospital stay.
Time frame: Until hospital discharge, up to 30 days
Duration of Mechanical Ventilation
Time from ICU admission to extubation (hours) and need for reintubation.
Time frame: Until hospital discharge, up to 30 days
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Bursa City Hospital