FLuid Responsiveness Prediction Using EXtra Systoles
In this study, the investigators propose to investigate a novel technique for fluid responsiveness prediction. It is based on the occurrence of an extra systole, which induces a preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with decreased cardiac preload, then, the post-ectopic beat with moderately increased preload.
Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the hemodynamic effect of increasing preload, i.e. giving fluids
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Groningen、荷兰、9713EZ
- Universitu Medical Center Groningen
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients requiring elective CABG or OPCAB surgery
- Patient's age ≥ 18 years
Exclusion Criteria:
- Patient refusal
- Pregnancy
- EF < 35%
- End stage kidney failure (defined by the need for haemodialysis)
- Patients with atrial fibrillation or frequent and coupled extra systoles (e.g. trigemini)
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：fluid challenge
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At two pre-defined time points during the procedure, enrolled patients will receive a fluid bolus of 5 ml/kg during 5 minutes
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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fluid challenge response in stroke volume
大体时间：during operation
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To investigate if post-ectopic induced changes in blood pressure before a fluid bolus (5 ml/kg) predicts the fluid induced change in cardiac stroke volume
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during operation
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合作者和调查者
出版物和有用的链接
一般刊物
- Holmgaard F, Vistisen ST, Ravn HB, Scheeren TWL. The response of a standardized fluid challenge during cardiac surgery on cerebral oxygen saturation measured with near-infrared spectroscopy. J Clin Monit Comput. 2020 Apr;34(2):245-251. doi: 10.1007/s10877-019-00324-w. Epub 2019 May 28.
- Vistisen ST, Berg JM, Boekel MF, Modestini M, Bergman R, Jainandunsing JS, Mariani MA, Scheeren TWL. Using extra systoles and the micro-fluid challenge to predict fluid responsiveness during cardiac surgery. J Clin Monit Comput. 2019 Oct;33(5):777-786. doi: 10.1007/s10877-018-0218-0. Epub 2018 Nov 9.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
fluid challenge的临床试验
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University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI); National Institute of Nursing Research (NINR)完全的
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Opera CRO, a TIGERMED Group Company完全的牙龈炎