持续输注与推注去甲肾上腺素治疗诱导后低血压 (INDUCT-Multi)
2026年6月24日 更新者：Kristen Thomsen、Universitätsklinikum Hamburg-Eppendorf
连续与推注去甲肾上腺素给药治疗高风险非心脏手术患者诱导后低血压——多中心 INDUCT 试验 (INDUCT-Multi)
INDUCT-Multi是一项多中心随机试验，旨在研究在全身麻醉诱导期间，与推注相比，持续输注去甲肾上腺素是否能降低高风险非心脏手术患者诱导后低血压的发生率。
研究概览
详细说明
全麻诱导后低血压，即诱导后低血压，在接受非心脏手术的患者中较为常见，并与急性肾损伤相关。 诱导后低血压的风险因素包括高龄、美国麻醉医师协会身体状况评分较高、慢性动脉高血压以及血管扩张性麻醉药物剂量较高。 合理假设，精细的麻醉管理有助于维持血压稳定并限制诱导后低血压。 与此假设一致，在全麻诱导期间使用动脉导管进行持续血压监测有助于临床医生减少诱导后低血压——因此建议用于有低血压相关并发症风险的非心脏手术患者。
除持续监测外，麻醉医师通常会给予血管升压药——如去甲肾上腺素——以维持血压。 去甲肾上腺素是一种起效快、半衰期短的血管升压药，通常在全麻诱导期间以重复的手动推注方式给药。 作为推注给药，它能有效且迅速地升高血压。 然而，推注需要频繁重复并精确计时以确保血压稳定。
在一项单中心随机试验中，我们证明了在全麻诱导期间持续（与推注相比）给予去甲肾上腺素有助于高危非心脏手术患者维持血压稳定。 我们现在旨在验证以下假设：对于通过动脉导管进行持续血压监测的高危非心脏手术患者，在全麻诱导期间持续（与推注相比）给予去甲肾上腺素可减少诱导后低血压。
研究类型
介入性
注册 (估计的)
446
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kristen K Thomsen, MD
- 电话号码：+4940741070215
- 邮箱：kr.thomsen@uke.de
学习地点
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Berlin、德国
- 尚未招聘
- Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
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接触：
- Sascha Treskatsch, MD
- 电话号码：+49 30 450 551 522
- 邮箱：sascha.treskatsch@charite.de
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Düsseldorf、德国
- 招聘中
- Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University Duesseldorf
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接触：
- Sebastian Roth, MD
- 电话号码：+49 211 81 16253
- 邮箱：Sebastian.Roth@med.uni-duesseldorf.de
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Hamburg、德国
- 招聘中
- Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
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接触：
- Kristen K Thomsen, MD
- 电话号码：+4940741070215
- 邮箱：kr.thomsen@uke.de
-
München、德国
- 招聘中
- Department of Anaesthesiology, University Hospital LMU Munich
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接触：
- Agnes Meidert, MD
- 电话号码：+49 89 440081065
- 邮箱：Agnes.meidert@med.uni-muenchen.de
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
我们将纳入年龄≥45岁、计划在全身麻醉下接受择期大型非心脏手术、计划通过桡动脉导管进行连续动脉内血压监测，并符合以下至少两项急性肾损伤风险标准的知情同意患者：
- 年龄≥65岁
- ASA身体状况III级或IV级
- 慢性动脉高血压
- 需要药物治疗的糖尿病
- 腹腔内手术
- 术前肾功能不全（血清肌酐≥1.2 mg/dL）
排除标准：
- 妊娠
- 心律失常
- 颅内出血或颅内动脉瘤病史
- 全身麻醉诱导期间有持续去甲肾上腺素输注的临床指征（例如，严重主动脉瓣狭窄、冠状动脉疾病或心力衰竭）
- 无法理解、阅读并提供德语知情同意的患者
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：持续去甲肾上腺素给药
对于被分配进行连续去甲肾上腺素给药的患者，去甲肾上腺素将通过注射泵连续给药。
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在分配至持续给予去甲肾上腺素的患者中，将准备一支注射器输液泵，并将其连接至外周或中心静脉导管。
负责的麻醉医师将开始去甲肾上腺素输注，并根据需要调整输注速率，如有必要，可通过注射器输液泵给予额外的去甲肾上腺素推注。
|
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无干预：推注去甲肾上腺素给药
在手动推注去甲肾上腺素组中，去甲肾上腺素将通过手动推注方式给药。
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min)
大体时间：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.
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Area under a MAP of 60 mmHg (mmHg x min)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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 <65 mmHg (min)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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.
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
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Acute kidney injury
大体时间：Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
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Nonfatal cardiac arrest
大体时间：Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
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Myocardial infarction
大体时间：Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
|
Death
大体时间：Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月7日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年3月31日
首先提交符合 QC 标准的
2026年4月15日
首次发布 (实际的)
2026年4月20日
研究记录更新
最后更新发布 (实际的)
2026年6月29日
上次提交的符合 QC 标准的更新
2026年6月24日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.