The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy
2022年9月22日 更新者：Jin-Tae Kim、Seoul National University Hospital
The Effect of Goal-directed Hemodynamic Therapy on Clinical Outcomes in Patients Undergoing Radical Cystectomy: : A Randomized Controlled Trial
Goal-directed therapy (GDT) has been applied to various clinical settings and has been widely researched recently as a method for perioperative management of patients.
Radical cystectomy is a complex surgical procedure in which the bladder is removed, followed by urinary diversion.
It is an extensive and time-consuming intervention and has high probability of fluid imbalance and bleeding during surgery.
We hypothesized that the application of GDT in these patients would improve clinical postoperative outcomes.
Therefore, we will attempt to evaluate improvement of postoperative outcomes after applying GDT protocol based on changes in stroke volume index, cardiac index and mean arterial pressure in radical cystectomy.
研究概览
研究类型
介入性
注册 (实际的)
82
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
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Select
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Seoul、Select、大韩民国、110-744
- Jin-Tae Kim
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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
20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:
- Patients undergoing open radical cystectomy
- Patients with American Society of Anesthesiologists physical status I-III
Exclusion Criteria:
- Significant hepatic dysfunction, significant renal dysfunction (estimated glomerular filtration rate <60 ml/min)
- Congestive heart failure (New York Heart Association scores ≥3), Left Ventricular Ejection Fraction < 35%
- Arrhythmia
- Coagulopathy (PT INR >1.5)
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Goal-directed therapy group
The patients in goal-directed therapy (GDT) group will be managed according to the goal-directed therapy protocol during the surgery.
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The patients in GDT group will receive intravenous crystalloid fluid or vasopressor or inotropic agent according to the goal-directed therapy protocol utilizing FloTrac / EV1000 clinical platform (Edwards Lifesciences, Irvine, CA, USA). After induction of anesthesia, the baseline stroke volume index (SVI) is measured and then 200-250 ml of crystalloid is administered over 5-10 minutes. If SVI increase by ≥10%, 200-250 ml of crystalloid is given repeatedly until the increase in SVI <10%. If SVI does not increase by ≥10% and there is no decrease in mean arterial pressure (MAP), revaluate SVI every 10 minutes. Despite an increase in SVI of <10% after fluid challenge, if a decrease in MAP is accompanied by cardiac index (CI) ≤ 2.5 L/min/m2, dobutamine is administered by continuous infusion. If there is a decrease in MAP but no decrease in CI, start low dose norepinephrine continuous infusion.
其他名称：
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无干预：Control group
The patients in control group will be managed according to standard perioperative care.
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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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A composite of postoperative complications
大体时间：through the hospitalization period, an average of 2 weeks
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Total incidence of postoperative complications including gastrointestinal complications, complications of infections, wound complications, cardiac events, thromboembolic complications, genitourinary complications, neurological complications based on the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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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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The incidence of postoperative gastrointestinal complications
大体时间：through the hospitalization period, an average of 2 weeks
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Gastrointestinal complications include ileus, constipation, gastric ulcer, anastomic bowel leak according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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The incidence of postoperative complications of infections
大体时间：through the hospitalization period, an average of 2 weeks
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Complications of infections include urinary tract infection, sepsis, pneumonia, wound infection according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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The incidence of postoperative wound complications
大体时间：through the hospitalization period, an average of 2 weeks
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Wound Complications mean wound dehiscence diagnosed clinically and requiring resuturing, according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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The incidence of postoperative cardiac events
大体时间：through the hospitalization period, an average of 2 weeks
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Cardiac events include myocardial infarction, arrhythmia, congestive heart failure, pulmonary edema and transient brain natriuretic peptide increase (serum brain natriuretic peptide values 100-500 pg/ml) according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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The incidence of postoperative thromboembolic complications
大体时间：through the hospitalization period, an average of 2 weeks
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Thromboembolic complication means pulmonary embolism evidenced by spiral computerized tomography scanning according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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The incidence of postoperative genitourinary complications
大体时间：through the hospitalization period, an average of 2 weeks
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Genitourinary complications include renal dysfunction, renal failure, urinary leakage according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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The incidence of postoperative neurological complications
大体时间：through the hospitalization period, an average of 2 weeks
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Neurological complications mean presence of a de novo focal deficit, confusion/delirium according to the Clavien-Dindo classification for radical cystectomy.
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through the hospitalization period, an average of 2 weeks
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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
- Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305. Erratum In: JAMA. 2014 Oct 8;312(14):1473.
- Wuethrich PY, Burkhard FC, Thalmann GN, Stueber F, Studer UE. Restrictive deferred hydration combined with preemptive norepinephrine infusion during radical cystectomy reduces postoperative complications and hospitalization time: a randomized clinical trial. Anesthesiology. 2014 Feb;120(2):365-77. doi: 10.1097/ALN.0b013e3182a44440.
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)
2018年4月20日
初级完成 (实际的)
2021年10月24日
研究完成 (实际的)
2021年10月24日
研究注册日期
首次提交
2018年4月4日
首先提交符合 QC 标准的
2018年4月12日
首次发布 (实际的)
2018年4月23日
研究记录更新
最后更新发布 (实际的)
2022年9月23日
上次提交的符合 QC 标准的更新
2022年9月22日
最后验证
2022年9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.
Goal-directed therapy的临床试验
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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
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Abbott Medical Devices完全的