The Effect of Dexmedetomidine on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery. Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and postoperative mortality. Aortic surgery is the most risky surgery that causes the postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.
The α1- and α2-adrenergic receptors in the kidney modulate vasoconstrictor and vasodilatory effects, respectively. Agents that attenuate renal vasoconstriction may have potential as renoprotective drugs because vasoconstriction most likely contributes to the pathophysiology of AKI. Clonidine, an α2-agonist, has been shown experimentally to inhibit renin release and cause a diuresis, and it has been evaluated in an experimental AKI model, confirming its potential as a renoprotective agent. Furthermore, it has been already reported that dexmedetomidine, α2-agonist, reduce the impairment of renal function after cardiac operation.
The aim of this study is to examine the association between preoperative dexmedetomidine infusion and the incidence of postoperative acute kidney injury(AKI) in patients undergoing aortic surgery.
調査の概要
状態
介入・治療
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Seoul、大韓民国、03722
- Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College 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
説明
Inclusion Criteria:
- the patients undergoing ascending, arch and/or proximal descending aorta surgery with cardiopulmonary bypass
- 20 - 100 yrs old
Exclusion Criteria:
- having preoperative severe renal dysfunction (eGFR < 15 ml/min per 1.73m2)
- Left ventricular-ejection fraction < 30%
- Preexisting congestive heart failure
- Severe coronary artery disease
- Hemodynamically unstable arrhythmia
- Cardiogenic shock during perioperative period
- Ventricular assist device use
- cannot communication because of a language barrier or illiteracy
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
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：dexmedetomidine
dexmedetomidine, 0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
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Immediately after the induction of anesthesia, patients in the dexmedetomidine group received dexmedetomidine continuous intravenous (IV) infusion of 0.4 mcg/kg/h until 24 hours after surgery.
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プラセボコンパレーター：control
saline, same infusion rate (received equal volume of normal saline), IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
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same infusion rate (received equal volume of normal saline), IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
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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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Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
時間枠：up to 7 days after the aortic surgery
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0.3 mg/dl increase in serum creatinine concentration within 48 hours OR, a 50% increase within 7 days postoperatively OR, urine volume < 0.5 ml/kg/h for 6 hours
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up to 7 days after the aortic surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
時間枠：up to 7 days after the surgery
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KDIGO stage 2: Serum creatinine increase to 2-3-fold from baseline OR urine output < 0.5 ml/kg/h for 12h
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up to 7 days after the surgery
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Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
時間枠：up to 7 days after the surgery
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KDIGO stage 3: Serum creatinine increase to 3.0-fold from baseline OR Increase in serum creatinine to ≥ 4 mg/dl OR Initiation of renal replacement therapy OR In patients <18 years, decrease in eGFR to < 35 ml/min per 1.73 m2 OR Anuria for ≥ 12h.
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up to 7 days after the surgery
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major morbidity endpoint
時間枠：acute kidney injury - up to 7 days after the surgery; Other - during the hospitalization for surgery
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acute kidney injury (same as the primary endpoint), permanent stroke, prolonged ventilator care >24h, deep wound infection, and mortality.
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acute kidney injury - up to 7 days after the surgery; Other - during the hospitalization for surgery
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postoperative delirium
時間枠：up to 7 days after the surgery
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delirium - assessed with The American Psychiatric Association's fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or Confusion Assessment Method for the ICU
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up to 7 days after the surgery
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drug-related adverse events
時間枠：hypotension or bradycardia: during surgery; Other - during surgery and 24 hours after surgery
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hypotension (mean arterial pressure <60 mmHg) or bradycardia (<50 beats/min) OR the use of vasopressor, inotropes or temporary pacing, OR postoperative arrhythmia
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hypotension or bradycardia: during surgery; Other - during surgery and 24 hours after surgery
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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
- 4-2015-0672
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