Management of Intraoperative Fluids in Ambulatory Surgery (MIFAS)
2020年3月2日 更新者：Renzo Di Natale、Policlinica Metropolitana
Intraoperative Fluid Therapy Management in Low-risk Patients Under General Anesthesia- a Randomized Controlled Trial Comparing Liberal, Restrictive and Pleth Variability Index (PVI)-Guided Fluid Administration in a Day Surgery Setting
This is a single-center prospective randomized control trial (RCT) to determine whether the continuous monitoring of the plethysmographic variability index (PVI) during low-risk surgeries, can be used to optimize the intraoperative fluid administration.
Low-risk patients that attend our day surgery unit, and who will be operated under general anesthesia, will be randomized to either a liberal fluid group, a restrictive fluid group or a dynamic monitoring group (PVI-directed).
The amount of fluid infused together with the time to discharge, will be assessed in each participant during the postoperative period along with additional secondary outcomes.
研究概览
研究类型
介入性
注册 (预期的)
243
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：Renzo G Di Natale, MD
- 电话号码：+584122715908
- 邮箱：renzogdg@gmail.com
学习地点
-
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Miranda
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Caracas、Miranda、委内瑞拉、01061
- Policlinica Metropolitana
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接触：
- Telephone central
- 电话号码：+582129080100
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首席研究员：
- Pascual M Carucci, MD
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副研究员：
- Renzo G Di Natale, MD
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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 至 65年 (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:
- participants attending the unit for a day surgery procedure
- participants whose surgeries will be performed under general anesthesia
- aged between 18-65 years
- no abnormal findings on chest x-ray or electrocardiogram on preoperative evaluation
- patients undergoing procedures which do not require opening of the abdominal or thoracic cavities
Exclusion Criteria:
- ASA score III or higher
- patients undergoing surgeries which require additional pain management procedures (e.g. selective nerve blockade, epidural anesthesia, etc.)
- known pregnant women
- known kidney disease (or serum creatinine >1.8 mg/dl)
- known liver disease (or AST/ALT >60 U/l)
- known chronic heart failure (determined by a LVEF <55%)
- participants who develop hypotension intraoperatively and do not respond to 4 fluid challenges (1000 ml), requiring aggressive fluid resuscitation OR vasopressors
- estimated blood loss during surgery >250 ml
- development of an adverse reaction to any of the drugs administered during surgery (requiring additional medical management)
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：支持治疗
- 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 |
|---|---|
|
有源比较器：Liberal group protocol
Fluid loading with 500 ml at induction.
Baseline fluid infusion - 8 ml/kg/h.
Fluid challenge - if mean arterial pressure (MAP) falls to < 65 mmHg, a fluid challenge will be administered.
|
Only ringer lactate (RL solution will be used).
1. Fluid loading at induction with 500 ml of ringer lactate solution will be given to some groups.
2. Base infusion rate varies according to group.
3. Fluid challenges - infusion of 250 ml over 5 min, a hemodynamic parameter specific to each group will be monitored for 10 min after the end of infusion to look for changes.
Patients who do not respond to four (4) fluid challenges (volume infused 1000 ml) will be excluded.
|
|
有源比较器：Restrictive group protocol
No fluid loading at induction.
Baseline fluid infusion - 4 ml/kg/h.
Fluid challenges - if mean arterial pressure (MAP) falls to < 65 mmHg, a fluid challenge will be administered.
|
Only ringer lactate (RL solution will be used).
1. Fluid loading at induction with 500 ml of ringer lactate solution will be given to some groups.
2. Base infusion rate varies according to group.
3. Fluid challenges - infusion of 250 ml over 5 min, a hemodynamic parameter specific to each group will be monitored for 10 min after the end of infusion to look for changes.
Patients who do not respond to four (4) fluid challenges (volume infused 1000 ml) will be excluded.
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实验性的：PVI-guided group protocol
No fluid loading at induction.
Baseline fluid infusion - 2 ml/kg/h.
PVI will be monitored continuously since anesthesia induction.
Fluid challenges - if PVI rises >=13 (or MAP falls < 65 mmHg), a fluid challenge will be administered.
|
Only ringer lactate (RL solution will be used).
1. Fluid loading at induction with 500 ml of ringer lactate solution will be given to some groups.
2. Base infusion rate varies according to group.
3. Fluid challenges - infusion of 250 ml over 5 min, a hemodynamic parameter specific to each group will be monitored for 10 min after the end of infusion to look for changes.
Patients who do not respond to four (4) fluid challenges (volume infused 1000 ml) will be excluded.
|
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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Total volume of fluid infused intraoperatively
大体时间：0 min after extubation
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Total volume of ringer lactate solution infused intraoperatively to participants (ml).
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0 min after extubation
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Time to discharge
大体时间：240 min after extubation (discharge)
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Time in hours (h) from anesthesia reversal to fulfillment of patient discharge criteria.
Patients will be assessed by an attending nurse every 30 min to assess the fulfillment of these criteria.
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240 min after extubation (discharge)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Significant postoperative nausea and vomiting (PONV)
大体时间：240 min after extubation (discharge)
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Presence of significant PONV as determined by a score ≥5 on the scale proposed by Myles SA et al. (BJA 2012)
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240 min after extubation (discharge)
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Postoperative dizziness
大体时间：30 min after reversal
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Presence of patient self-reported dizziness in the post-operative period.
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30 min after reversal
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Postoperative fatigue
大体时间：30 min after reversal
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Presence of patient self-reported fatigue after surgery.
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30 min after reversal
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Postoperative thirst
大体时间：30 min after reversal
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Presence of patient self-reported thirst after surgery
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30 min after reversal
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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。
调查人员
- 研究主任：Pascual M Carucci, MD、Policlinica Metropolitana
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 (预期的)
2020年12月1日
初级完成 (预期的)
2021年12月1日
研究完成 (预期的)
2023年12月1日
研究注册日期
首次提交
2017年6月15日
首先提交符合 QC 标准的
2017年6月16日
首次发布 (实际的)
2017年6月20日
研究记录更新
最后更新发布 (实际的)
2020年3月3日
上次提交的符合 QC 标准的更新
2020年3月2日
最后验证
2020年3月1日
更多信息
与本研究相关的术语
其他研究编号
- 1701
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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 therapy protocol的临床试验
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI); National Institute of Nursing Research (NINR)完全的
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University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的