Lactate Levels During Cardiopulmonary Bypass in Pediatric Patients
Changes of Lactate Levels During Cardiopulmonary Bypass in Pediatric Undergoing Cardiac Surgery: Possible Early Marker of Morbidity and Mortality
調査の概要
詳細な説明
Forty consecutive pediatric patients who required cardiopulmonary bypass for repair or palliation of complex congenital heart disease will be enrolled in this study. Patients for the study were selected by convenience sampling, without randomization or control of surgical procedure, conduct of anesthesia, or CPB management.
Patients will be monitored intra-operatively using ECG, invasive and non-invasive blood pressure monitoring, pulse oximetry and capnography for determination of End Tidal Co2 ( ETCo2 ) and nasopharyngeal temperature. After induction of anesthesia and placement of an intra-arterial catheter 1 ml of arterial blood will collected into a heparinized 3 ml blood gas syringe and immediately analyzed on the arterial blood gas analyzer (GEM Premier 3000) for blood gas, hematocrit, electrolytes, calcium and glucose. Management strategy of cardio-pulmonary bypass (CPB) was standardized for all the patients. Lactate samples will drawn at specific time points within 5 time intervals: before CPB after induction, during cooling on CPB, during rewarming on CPB, immediately after CPB in the operating room, and after admission to the post-operative intensive care unit.
Differences in lactate levels related to diagnosis will examined. To examine the effect of patient diagnosis and surgical risk on serum lactate level and outcome, the investigators separated patients into surgical risk categories Risk adjustment for congenital heart surgery (RACHS-1). This classification does not include heart transplantation. Patient mortality and the prevalence of postoperative complications for each of the 3 surgical risk categories relative to the change in lactate will examined.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Assiut、エジプト、74111
- Faculty of Medicine
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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
説明
Inclusion Criteria:
- age range (1-12 years)
- Usage of cardiopulmonary bypass
Exclusion Criteria:
- chest problems
- Renal problems
- Hepatic problems
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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Lactate
Lactate samples will drawn at specific time points within 5 time intervals: before CPB after induction, during cooling on CPB, during rewarming on CPB, immediately after CPB in the operating room, and after admission to the post-operative intensive care unit.
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Lactate samples will drawn at specific time points within 5 time intervals: before CPB after induction, during cooling on CPB, during rewarming on CPB, immediately after CPB in the operating room, and after admission to the post-operative intensive care unit.
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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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Serum lactate during CPB
時間枠:first 24 hours
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lactate value (mmol/L)
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first 24 hours
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協力者と研究者
スポンサー
捜査官
- 主任研究者:sayed abd elshafy, MD、Associate Professor
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。
先天性心疾患の臨床試験
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Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)