Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Free Flaps
2019年5月14日 更新者：Zsolt Molnár, MD, PhD, DEAA、Szeged University
Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Microcirculation in Free Flap Reconstruction of Intraoral Tumours.
Maintaining satisfactory tissue perfusion is an essential of success during reconstructive free flap surgery following malign oral cavity tumours.
Intra- and postoperative goal-directed fluid therapy is an appropriate tool for that.
Continuous cardiac output monitoring based fluid loading (complemented with vasopressor and/or inotropes if necessary) might be superior to conventional, central venous and arterial pressure monitoring in terms of morbidity, complications, optimal fluid balance and days spent in hospital.
However, there is no data describing the effects of goal-directed fluid therapy (crystalloid or colloid) on microcirculation of free flaps implanted in the oral cavity during the post-operative period.
The aim of this study is to observe the effects of continuous macrohaemodynamic monitoring based, goal-directed fluid therapy on microcirculation of forearm flaps during the perioperative period.
研究概览
研究类型
介入性
注册 (实际的)
30
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。
学习地点
-
-
Csongrád
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Szeged、Csongrád、匈牙利、6725
- Department of Anaesthesiology and Intensive Therapy
-
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age over 18
- Tumour location: intraoral
- Free flap type: radial forearm
- Signed informed concent form
Exclusion Criteria:
- Vulnerable subject as defined in International Standards Organization 14155:2011
- End stage oral cancer
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Crystalloid group
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Primary fluid admission: 1 mL/bodyweight kg/ hour crystalloid.
If Pulse pressure variation is lower than 10%; 250 mL/15 min of colloid or crystalloid is administered depending on randomization.
Norepinephrine is administered if Mean arterial pressure drops below 65 mmHg.
Mean arterial pressure must be maintained above 65 mmHg.
Norepinephrine is titrated accordingly.
Dobutamine is administered if Cardiac index drops below 2.5 L/min/m2.
Cardiac index must be maintained above 2.5 L/min/m2.
Dobutamine is titrated accordingly.
|
|
有源比较器：Colloid group
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Primary fluid admission: 1 mL/bodyweight kg/ hour crystalloid.
If Pulse pressure variation is lower than 10%; 250 mL/15 min of colloid or crystalloid is administered depending on randomization.
Norepinephrine is administered if Mean arterial pressure drops below 65 mmHg.
Mean arterial pressure must be maintained above 65 mmHg.
Norepinephrine is titrated accordingly.
Dobutamine is administered if Cardiac index drops below 2.5 L/min/m2.
Cardiac index must be maintained above 2.5 L/min/m2.
Dobutamine is titrated accordingly.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Changes of Pulse pressure variation during the operation and the post-operative 24 hours
大体时间：24 hours
|
24 hours
|
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Assesment of free falp microcirculation by laser dopler flowmetry method.
大体时间：24 hours
|
24 hours
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Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours.
大体时间：24 hours
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24 hours
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Changes of Cardiac Index during the operation and the post-operative 24 hours.
大体时间：24 hours
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24 hours
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Mean arterial pressure during the operation and the post-operative 24 hours.
大体时间：24 hours
|
24 hours
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Length of Intensive Care Unit stay
大体时间：24 hours
|
24 hours
|
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Number of surgical or non-surgical complications.
大体时间：24 hours
|
24 hours
|
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Length of Hospital stay
大体时间：10 days
|
10 days
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11. Erratum In: Intensive Care Med. 2015 Sep;41(9):1737-8. multiple investigator names added.
- Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.
- Holzle F, Rau A, Loeffelbein DJ, Mucke T, Kesting MR, Wolff KD. Results of monitoring fasciocutaneous, myocutaneous, osteocutaneous and perforator flaps: 4-year experience with 166 cases. Int J Oral Maxillofac Surg. 2010 Jan;39(1):21-8. doi: 10.1016/j.ijom.2009.10.012. Epub 2009 Nov 26.
- Laszlo I, Janovszky A, Lovas A, Vargan V, Oveges N, Tanczos T, Mikor A, Trasy D, Loderer Z, Piffko J, Szabo A, Molnar Z. Effects of goal-directed crystalloid vs. colloid fluid therapy on microcirculation during free flap surgery: A randomised clinical trial. Eur J Anaesthesiol. 2019 Aug;36(8):592-604. doi: 10.1097/EJA.0000000000001024.
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)
2014年4月28日
初级完成 (实际的)
2017年2月28日
研究完成 (实际的)
2018年9月19日
研究注册日期
首次提交
2017年8月29日
首先提交符合 QC 标准的
2017年9月15日
首次发布 (实际的)
2017年9月19日
研究记录更新
最后更新发布 (实际的)
2019年5月15日
上次提交的符合 QC 标准的更新
2019年5月14日
最后验证
2019年5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.
Fluid management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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George Washington UniversityTranscultural Psychosocial Organization Nepal完全的