MIECC vs Conventional Cardiopulmonary Bypass and Systemic Inflammation in CABG (MIECC-CABG)
Comparison of the Effects of Minimally Invasive and Conventional Extracorporeal Circulation on Systemic Inflammation Indices in Coronary Artery Bypass Surgery
調査の概要
状態
詳細な説明
Coronary artery bypass graft surgery performed with cardiopulmonary bypass is associated with activation of systemic inflammatory pathways. Contact of blood with the extracorporeal circuit, surgical trauma, ischemia-reperfusion injury, and perioperative factors may contribute to this response. Minimally invasive extracorporeal circulation systems are designed to reduce blood-air contact, circuit surface area, and hemodilution and may therefore attenuate the inflammatory response compared with conventional cardiopulmonary bypass.
In this prospective observational study, patients undergoing elective coronary artery bypass graft surgery will be evaluated according to whether minimally invasive extracorporeal circulation or conventional extracorporeal circulation is used during surgery. No treatment assignment will be made by the study protocol.
Inflammatory response will be assessed using neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and systemic immune-inflammation index calculated from routinely obtained laboratory measurements. Measurements will be evaluated preoperatively, at 6 hours after surgery, at 24 hours after surgery, and at hospital discharge. Perioperative variables and postoperative clinical outcomes will also be recorded for comparison between the two groups.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Ümran Karaca, M.D.
- 電話番号：+90 505 494 16 87
- メール：umransuna@gmail.com
研究場所
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Bursa
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Bursa、Bursa、トルコ（Türkiye）、16000
- 募集
- Bursa Yuksek Ihtisas Training and Research Hospital
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コンタクト：
- Ümran Karaca, M.D.
- 電話番号：+90 505 494 16 87
- メール：umransuna@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age 30-70 years
- Patients undergoing elective coronary artery bypass graft surgery
- Patients in whom cardiopulmonary bypass is planned
- Written informed consent obtained
Exclusion Criteria:
- Emergency surgery
- Redo cardiac surgery
- Concomitant valve surgery
- Previous open heart surgery
- Preoperative renal and/or hepatic failure
- Malignancy
- Active infection or inflammatory disease-
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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MIECC Group
Patients undergoing coronary artery bypass graft surgery using minimally invasive extracorporeal circulation (MIECC) as part of routine clinical care.
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Use of a minimally invasive extracorporeal circulation system during coronary artery bypass graft surgery as part of routine clinical care.
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Conventional Cardiopulmonary Bypass Group
Patients undergoing coronary artery bypass graft surgery using conventional cardiopulmonary bypass as part of routine clinical care.
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Use of conventional cardiopulmonary bypass during coronary artery bypass graft surgery as part of routine clinical care.
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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 |
|---|---|---|
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Neutrophil-to-Lymphocyte Ratio (NLR)
時間枠：Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
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NLR will be calculated from routine complete blood count values by dividing the absolute neutrophil count by the absolute lymphocyte count.
Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
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Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
|
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Platelet-to-Lymphocyte Ratio (PLR)
時間枠：Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
|
PLR will be calculated from routine complete blood count values by dividing the platelet count by the absolute lymphocyte count.
Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
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Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
|
|
Systemic Immune-Inflammation Index (SII)
時間枠：Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
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SII will be calculated as neutrophil count × platelet count / lymphocyte count using routine complete blood count values.
Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
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Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.
|
協力者と研究者
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
キーワード
その他の研究ID番号
- 2024-TBEK 2026/01-10
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
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