Can Cardiac Cycle Efficiency predict high-dose vasoactive-inotropic needs after open-heart surgery?
Official 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
Run by Bursa City Hospital · NCT07926360 · Data updated 2026-11-12
This study tests whether Cardiac Cycle Efficiency measured after coming off bypass can predict which adults will need high doses of vasoactive and inotropic meds in the first 24 hours after open-heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | Bursa City Hospital Government |
| Locations | 1 site (Nilufer, Bursa) |
| Status | Recruiting |
| Started | November 1, 2026 |
| Main results expected | January 15, 2027 |
| Study ends | January 15, 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07926360 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older undergoing elective CABG, valve surgery, or combined CABG and valve surgery with CPB, who can consent and have reliable arterial monitoring.
✕Probably not a fit
Patients with unstable arterial waveforms, emergency surgeries, or those needing immediate circulatory support may not benefit from this marker's predictive value.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center prospective observational study will analyze hemodynamic data collected from arterial lines at six perioperative time points after cardiopulmonary bypass. Cardiac Cycle Efficiency (CCE) is derived from arterial waveform analysis using MostCare Up and will be evaluated for its ability to predict a maximum VIS of 15 or higher within 24 hours postoperatively. The predictive performance will be assessed with ROC analysis, and associations with lactate levels, duration of mechanical ventilation, ICU/hospital stay, acute kidney injury, and in-hospital mortality will be explored. No additional procedures will be performed beyond routine care, and data come from standard arterial monitoring. The goal is to identify early markers of patients at risk for significant vasopressor/inotrope support.
Why it matters
Potential benefit: If successful, CCE could help clinicians identify patients at risk for high inotropic/vasoactive needs early after surgery, enabling more timely management.
How similar studies have gone: Prior findings in children suggest CCE relates to inotropic needs; applicability in adults remains to be proven, making this approach exploratory in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Bursa City Hospital
Nilufer, Bursa, Turkey (Türkiye) Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.