個別化された周術期血圧管理と従来の周術期血圧管理
大規模な非心臓手術後の心臓、脳血管、腎臓の重大な有害事象に対する個別血圧管理と従来の血圧管理の効果：多施設ランダム化比較試験
Study objective: To compare the effect of different perioperative blood pressure management strategies on major postoperative adverse outcomes / Study design: a multicenter, randomized controlled trial / Participants: 1896 patients undergoing major non-cardiac surgery / Methods: Patients are randomized into two groups, the individualized strategy (maintaining perioperative mean arterial pressure and systolic blood pressure more than -20% of their baseline values) or the conventional strategy (maintaining perioperative mean arterial pressure ≥65 mmHg and systolic blood pressure ≥90 mmHg in all patients). Then, the frequency of major postoperative adverse outcomes occurring within 7 postoperative days or before discharge (whichever occurs first). / Primary outcome: a composite of all-cause death, stroke, myocardial infarction, new or worsening congestive heart failure, unplanned coronary revascularization, and acute kidney injury, occuring within 7 postoperative days or before discharge (whichever occurs first).
調査の概要
状態
条件
詳細な説明
This study, aiming to reflect real clinical scenarios as much as possible, does not impose specific restrictions on perioperative management other than the target blood pressure. It allows discretion to each participating institution or physician. For the same reason, there are no restrictions on method for blood pressure measurement (invasive, non-invasive, or both), site of blood pressure measurement, fluid therapy, and vasopressors use for maintaining target blood pressure in each group.
Through random allocation, the conventional group targets a mean arterial pressure (MAP) of 65 mmHg or higher and a systolic blood pressure (SBP) of 90 mmHg or higher during surgery. The individualized group targets no less than a -20% of the baseline MAP and SBP. The baseline MAP and SBP are defined as the average values of all MAP and SBP measured between one day before surgery and the morning of the surgery.
The two blood pressure management strategies are applied until discharge from the post-anesthesia care unit. If the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the blood pressure management strategies are applied until the end of surgery.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Seongnam、韓国
- Seoul National University Bundang Hospital
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Seoul、韓国、03080
- Seoul National University Hospital
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Seoul、韓国
- Korea University Guro Hospital
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Seoul、韓国
- Samsung Medical Center
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Suwon、韓国
- Ajou University Hospital
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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:
- Patients aged ≥65 or,
- those aged ≥45 with a history of coronary artery disease, peripheral vascular disease, transient ischemic attack/stroke, or congestive heart failure,
- undergoing non-cardiac surgery under general anesthesia with an anticipated duration of ≥2 hours.
Exclusion Criteria:
- Emergency surgery
- Organ transplantation surgery
- Brain/carotid artery surgery
- American Society of Anesthesiologists physical status 5 or 6
- Pregnancy
- Uncontrolled preoperative hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg)
- Estimated glomerular filtration rate <30 ml/min/1.73m2
- Renal replacement therapy
- Acute decompensated heart failure
- Sepsis
- Shock
- Use of inotropes/vasopressor infusion (dopamine, norepinephrine, vasopressin, etc.)
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Individualized strategy
Targeting mean arterial pressure and systolic blood pressure of ≥ -20% of their baseline values in each patient during surgery. The baseline values are defined as the average of all measurements between one day before surgery and the morning of the surgery. The target is applied until discharge from the post-anesthesia care unit. If the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the strategy is applied until the end of surgery. The target is applied until discharge from the post-anesthesia care unit. It the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the strategy is applied until the end of surgery. |
In this group, perioperative mean arterial pressure and systolic blood pressure are maintained at no less than -20% of the baseline values of each patient. |
|
アクティブコンパレータ：Conventional strategy
Targeting a mean arterial pressure of 65 mmHg or higher and a systolic blood pressure of 90 mmHg or higher during surgery. The target is applied until discharge from the post-anesthesia care unit. If the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the strategy is applied until the end of surgery. |
In this group, perioperative mean arterial pressure and systolic blood pressure are maintained at ≥65 mmHg and ≥90 mmHg, respectively, in all patients. |
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 |
|---|---|---|
|
The incidence of postoperative major adverse cardiac, cerebrovascular, and renal event
時間枠：Occuring until discharge or postoperative day 7, whichever occurs first
|
A composite of all-cause death, stroke, myocardial infarction, new or worsening congestive heart failure, unplanned coronary revascularization, and acute kidney injury. |
Occuring until discharge or postoperative day 7, whichever occurs first
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
all-cause death
時間枠：until discharge or postoperative day 7, whichever occurs first
|
death of any cause after surgery |
until discharge or postoperative day 7, whichever occurs first
|
|
stroke
時間枠：until discharge or postoperative day 7, whichever occurs first
|
a new ischemic or hemorrhagic cerebrovascular accident with a neurological deficit confirmed by brain imaging |
until discharge or postoperative day 7, whichever occurs first
|
|
myocardial infarction
時間枠：until discharge or postoperative day 7, whichever occurs first
|
Diagnosed based on the Fourth Universal Definition of Myocardial Infarction (Type 1,2, and 3). |
until discharge or postoperative day 7, whichever occurs first
|
|
new or worsening congestive heart failure
時間枠：until discharge or postoperative day 7, whichever occurs first
|
Congestive heart failure: diagnosis on discharge letter or progression notes (medical records: pulmonary edema, congestive heart failure, etc.) |
until discharge or postoperative day 7, whichever occurs first
|
|
unplanned coronary revascularization
時間枠：until discharge or postoperative day 7, whichever occurs first
|
percutaneous coronary intervention or bypass grafting, which was not an a priori planned stepwise procedure. |
until discharge or postoperative day 7, whichever occurs first
|
|
acute kidney injury
時間枠：until discharge or postoperative day 7, whichever occurs first
|
Defined based on the serum creatinine criteria of the Kidney Disease: Improving Global Outcomes (KDIGO). A. Increase in serum creatinine level by 0.3 mg/dl or more within 48 hours, or B. Increase in serum creatinine level to 1.5 times the baseline or more within 7 days. The baseline serum creatinine level was defined as the most recent value measured prior to surgery. |
until discharge or postoperative day 7, whichever occurs first
|
|
Length of postoperative hospital stay (days)
時間枠：assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)
|
Length of postoperative hospital stay described in days |
assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)
|
|
Unplanned ICU admission
時間枠：assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)
|
Unplanned intensive care unit admission after surgery |
assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)
|
|
new-onset atrial fibrillation
時間枠：until discharge or postoperative day 7, whichever occurs first
|
New-onset atrial fibrillation of any duration captured on 12-lead electrocardiogram, continuous electrocardiogram monitoring, or telemetry. |
until discharge or postoperative day 7, whichever occurs first
|
協力者と研究者
捜査官
- 主任研究者：Karam nam, M.D., Ph.D.、Seoul National University Hospital
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 (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
その他の研究ID番号
- SPROUT-4
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米国FDA規制機器製品の研究
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