Cardiac Cycle Efficiency and Vasoactive-Inotropic Support After Cardiac Surgery (CCE-VIS)
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
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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
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Bursa
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Nilufer, Bursa, Turkiet (Türkiye), 16110
- Rekrytering
- Bursa City Hospital
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Kontakt:
- emre ulusoy
- Telefonnummer: 05379492799
- E-post: emreulusoy36@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Adult patients undergoing elective open-heart surgery with cardiopulmonary bypass at Bursa City Hospital.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
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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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Predictive Performance of CCE for High Vasoactive-Inotropic Support
Tidsram: First 24 hours after ICU admission
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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. |
First 24 hours after ICU admission
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Predictive Performance of Early CCE (T3 and Mean T3-T4)
Tidsram: First 24 hours after ICU admission
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ROC analysis of CCE at 15 minutes after bypass and mean of 15- and 30-minute CCE values for predicting VISmax ≥15. |
First 24 hours after ICU admission
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Vasoactive-Inotropic Score
Tidsram: 24 hours
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VIS at ICU admission, 6 hours and 24 hours after ICU admission. |
24 hours
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Serum Lactate and Lactate Clearance
Tidsram: 24 hours
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Lactate (mmol/L) at ICU admission, 6 and 24 hours; lactate clearance in the first 6 hours (%). |
24 hours
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In-Hospital Mortality
Tidsram: Until hospital discharge, up to 30 days
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All-cause death during hospital stay. |
Until hospital discharge, up to 30 days
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Duration of Mechanical Ventilation
Tidsram: Until hospital discharge, up to 30 days
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Time from ICU admission to extubation (hours) and need for reintubation. |
Until hospital discharge, up to 30 days
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
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Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BSH0003
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