持続的投与とボーラス投与によるノルエピネフリンを用いた誘導後低血圧の治療 (INDUCT-Multi)
2026年6月24日 更新者：Kristen Thomsen、Universitätsklinikum Hamburg-Eppendorf
高リスク非心臓手術患者における誘導後低血圧の治療のための持続的投与とボーラス投与のノルエピネフリン投与 - 多施設共同INDUCT試験 (INDUCT-Multi)
INDUCT-Multiは、高リスク非心臓手術患者において、全身麻酔導入中のノルエピネフリンの持続投与が、ボーラス投与と比較して、導入後低血圧を減少させるかどうかを調査する多施設ランダム化試験です。
調査の概要
詳細な説明
全身麻酔導入後の低血圧、すなわち導入後低血圧は、非心臓手術を受ける患者において一般的であり、急性腎障害と関連しています。 導入後低血圧のリスク要因には、高齢、米国麻酔科学会身体状態分類の高いステータス、慢性動脈性高血圧、および血管拡張性麻酔薬の高用量が含まれます。 注意深い麻酔管理が血圧安定性の維持と導入後低血圧の抑制に役立つと考えるのは妥当です。 この仮定に一致して、全身麻酔導入中の動脈カテーテルによる連続血圧モニタリングは、導入後低血圧を減少させるのに臨床医を支援し、したがって低血圧関連合併症のリスクがある非心臓手術患者に推奨されます。
連続モニタリングに加えて、麻酔科医は通常、血圧を維持するためにノルエピネフリンなどの昇圧薬を投与します。 ノルエピネフリンは半減期が短い速効性の昇圧薬であり、通常、全身麻酔導入中に繰り返し手動ボーラス投与されます。 ボーラスとして投与されることで、血圧を効果的かつ迅速に上昇させます。 しかし、血圧安定性を確保するためには、ボーラスを頻繁に繰り返し、適切なタイミングで投与する必要があります。
単施設無作為化試験において、我々は、全身麻酔導入中のノルエピネフリンの連続投与が、ボーラス投与と比較して、高リスク非心臓手術患者の血圧安定性維持に役立つことを実証しました。 現在、我々は、動脈カテーテルによる連続血圧モニタリングを受けている高リスク非心臓手術患者において、全身麻酔導入中のノルエピネフリンの連続投与が、ボーラス投与と比較して導入後低血圧を減少させるという仮説を検証することを目指しています。
研究の種類
介入
入学 (推定)
446
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Kristen K Thomsen, MD
- 電話番号：+4940741070215
- メール：kr.thomsen@uke.de
研究場所
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Berlin、ドイツ
- まだ募集していません
- Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
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コンタクト：
- Sascha Treskatsch, MD
- 電話番号：+49 30 450 551 522
- メール：sascha.treskatsch@charite.de
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Düsseldorf、ドイツ
- 募集
- Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University Duesseldorf
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コンタクト：
- Sebastian Roth, MD
- 電話番号：+49 211 81 16253
- メール：Sebastian.Roth@med.uni-duesseldorf.de
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Hamburg、ドイツ
- 募集
- Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
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コンタクト：
- Kristen K Thomsen, MD
- 電話番号：+4940741070215
- メール：kr.thomsen@uke.de
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München、ドイツ
- 募集
- Department of Anaesthesiology, University Hospital LMU Munich
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コンタクト：
- Agnes Meidert, MD
- 電話番号：+49 89 440081065
- メール：Agnes.meidert@med.uni-muenchen.de
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
対象者選定基準:
同意を得た患者で、45歳以上、全身麻酔下での選択的メジャー非心臓手術を予定しており、橈骨動脈カテーテルによる連続的動脈内血圧モニタリングを計画し、急性腎障害発症のリスク基準を少なくとも2つ満たす患者を含みます:
- 年齢65歳以上
- ASA身体状態分類IIIまたはIV
- 慢性動脈性高血圧
- 薬物治療を要する糖尿病
- 腹腔内手術
- 術前腎機能不全（血清クレアチニン≧1.2 mg/dL）
除外基準:
- 妊娠中
- 不整脈
- 頭蓋内出血または頭蓋内動脈瘤の既往
- 全身麻酔導入中に持続的ノルエピネフリン投与の臨床的適応がある場合（例：重度の大動脈弁狭窄症、冠動脈疾患、心不全）
- ドイツ語での説明を理解し、読み、インフォームドコンセントを提供できない患者
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ダブル
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：持続的ノルエピネフリン投与
連続的ノルエピネフリン投与群の患者において、ノルエピネフリンはシリンジ注入ポンプを介して連続的に投与されます。
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ノルエピネフリンの持続投与が割り当てられた患者では、シリンジ注入ポンプを準備し、末梢静脈カテーテルまたは中心静脈カテーテルに接続します。担当麻酔科医がノルエピネフリンの注入を開始し、必要に応じて注入速度を調整します。また、必要に応じてシリンジ注入ポンプを介して追加のノルエピネフリンをボーラス投与する場合があります。
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介入なし：ボーラスノルエピネフリン投与
手動ボーラスノルエピネフリン投与群に割り付けられた患者では、ノルエピネフリンを手動でボーラス投与します。
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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 |
時間枠 |
|---|---|
|
Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
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First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Area under a MAP of 60 mmHg (mmHg x min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Area under a MAP of 50 mmHg (mmHg x min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Area under a MAP of 40 mmHg (mmHg x min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Area above a MAP of 100 mmHg (mmHg x min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Area above a MAP of 110 mmHg (mmHg x min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Area above a MAP of 120 mmHg (mmHg x min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Area above a MAP of 140 mmHg (mmHg x min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
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Duration of a MAP <65 mmHg (min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP <60 mmHg (min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP <50 mmHg (min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP <40 mmHg (min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP >100 mmHg (min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP >110 mmHg (min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP >120 mmHg (min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Duration of a MAP >140 mmHg (min)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement <65 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement <60 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement <50 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement <40 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement >100 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement >110 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement >120 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with any MAP measurement >140 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <65 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <60 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <50 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <40 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >100 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >110 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >120 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >140 mmHg
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
|
Cumulative dose of norepinephrine indexed to body weight (µg kg-1)
時間枠：First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
|
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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Acute kidney injury
時間枠：Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
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Nonfatal cardiac arrest
時間枠：Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
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Myocardial infarction
時間枠：Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
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Death
時間枠：Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月7日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2026年3月31日
QC基準を満たした最初の提出物
2026年4月15日
最初の投稿 (実際)
2026年4月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月29日
QC基準を満たした最後の更新が送信されました
2026年6月24日
最終確認日
2026年6月1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。