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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
Bursa
-
Nilufer、Bursa、トルコ（Türkiye）、16110
- 募集
- Bursa City Hospital
-
コンタクト：
- emre ulusoy
- 電話番号：05379492799
- メール：emreulusoy36@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adult patients undergoing elective open-heart surgery with cardiopulmonary bypass at Bursa City Hospital.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Predictive Performance of CCE for High Vasoactive-Inotropic Support
時間枠：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. |
First 24 hours after ICU admission
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Predictive Performance of Early CCE (T3 and Mean T3-T4)
時間枠：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. |
First 24 hours after ICU admission
|
|
Vasoactive-Inotropic Score
時間枠：24 hours
|
VIS at ICU admission, 6 hours and 24 hours after ICU admission. |
24 hours
|
|
Serum Lactate and Lactate Clearance
時間枠：24 hours
|
Lactate (mmol/L) at ICU admission, 6 and 24 hours; lactate clearance in the first 6 hours (%). |
24 hours
|
|
In-Hospital Mortality
時間枠：Until hospital discharge, up to 30 days
|
All-cause death during hospital stay. |
Until hospital discharge, up to 30 days
|
|
Duration of Mechanical Ventilation
時間枠：Until hospital discharge, up to 30 days
|
Time from ICU admission to extubation (hours) and need for reintubation. |
Until hospital discharge, up to 30 days
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BSH0003
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。