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Crystalloids Versus Colloids During Surgery (CC)

2018年1月8日 更新者:Barbara Kabon、Medical University of Vienna

A Comparison of Crystalloids vs. Colloids for Intraoperative Goal-directed Fluid Management

The purpose of the study is to test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management. Goal-directed therapy is based on measurements by an Esophageal Doppler Device.

研究概览

详细说明

For a long time there is a raging debate whether crystalloid solutions or colloid solutions are better suited for fluid therapy. Early proponents both for crystalloids [Shires 1961] and colloids [Shoemaker 1979] deserve credit for elucidating important facts about volume replacement therapy - without answering the primary question. Elaborate reviews comparing crystalloid and colloid therapy for critically ill patients have been performed in the late nineties and updated recently [Roberts 2004]. However, it has been suggested that both questions and answers of reviews leave us none but wiser [Webb 1999]. Although a plethora of studies comparing crystalloid vs. colloid therapy in the last decades have been published, volume replacement therapy is still considered to be based on dogma and personal beliefs [Boldt 2003].

Goal-directed intraoperative fluid therapy monitored by Esophageal Doppler identifies volume-responders, thereby decreasing length of stay in hospital in orthopedic [Sinclair 1997], cardiac [Mythen 1995], and abdominal surgery patients [Gan 2002, Wakeling 2005, Noblett 2006]. However, all these studies have been performed with a colloid to be the substance applied. Thus, it has been questioned whether monitoring with the Esophageal Doppler monitor, or the application of additional colloid improved outcome [Horowitz, Kumar 2003].

Consequently, the researchers will use Esophageal Doppler Monitoring for intraoperative goal-directed fluid therapy to compare the effects of crystalloid vs. colloid therapy on various organ systems, assessing combined perioperative morbidity [Bennett-Guerrero 1999] .

研究类型

介入性

注册 (实际的)

1109

阶段

  • 第四阶段

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

      • Vienna、奥地利、1090
        • Medical University of Vienna

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 80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:

  • After written informed consent patients undergoing elective open colon surgery, or open hysterectomy or myomectomy, or spine surgery or hip replacement will be included in the study.

Exclusion Criteria:

  • Patients having severe cardiac or renal insufficiency
  • Patients with severe coronary artery disease
  • Patients with insulin-dependent diabetes mellitus
  • Patients with severe COPD
  • Patients with symptoms of infections or sepsis
  • Patients with allergy to hydroxyethylstarch.

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:四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器:1
Arm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered.
Arm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered.
有源比较器:2
Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered.
Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
combined perioperative morbidity
大体时间:30 days after surgery
30 days after surgery

次要结果测量

结果测量
大体时间
Tissue oxygenation, Wound Infection, Incidence of postoperative nausea and vomiting (PONV) and pain, pulmonary function,
大体时间:30 days after surgery
30 days after surgery

其他结果措施

结果测量
措施说明
大体时间
Coagulation (ROTEM)
大体时间:intraop, postop day1
in a subgroup of 50 patients undergoing hepatic resection ROTEM measurements will be performed intraoperatively, postoperatively and on the first postoperative morning and compared between the groups.
intraop, postop day1
Inflammatory response attenuation by HES 130/0.4
大体时间:4 postoperative days

In a subgroups of 120 patients the postoperative immune function will be evaluated and compared between crystalloids and colloids.

The immunological parameters include:

IL6, IL-8, IL-10, Procalcitonin, lipopolysaccharide-binding protein, HLA-DR Expression, CRP C-reactive protein, leucocytes, TNF alpha Blood samples will be collected immediately before surgery (T0) for baseline measurement, immediately after surgery finish (T1), and on postoperative day one, two and four (T2, T3 and T4).

4 postoperative days
Body Composition Monitor Measurement (BCM)
大体时间:pre and postoperatively

In a subgroup of 100 patients overhydration will be evaluated pre- and immediately postoperatively with a body composition monitor (BCM), a whole-body bioimpedance spectroscopy device manufactured and distributed by Fresenius Medical Care, Germany.

Measurements will be compared betwwen the groups

pre and postoperatively

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。

合作者

调查人员

  • 首席研究员:Edith Fleischmann, M.D., Ph.D.、Department of Anesthesiology, University of Vienna Medical School, Vienna, Austria

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

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

2006年9月1日

初级完成 (实际的)

2016年12月31日

研究完成 (实际的)

2016年12月31日

研究注册日期

首次提交

2007年8月15日

首先提交符合 QC 标准的

2007年8月15日

首次发布 (估计)

2007年8月16日

研究记录更新

最后更新发布 (实际的)

2018年1月10日

上次提交的符合 QC 标准的更新

2018年1月8日

最后验证

2018年1月1日

更多信息

与本研究相关的术语

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.

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