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Restricted Fluid Regimen in Open Abdominal Bowel Surgery

2017年3月3日 更新者:Balachundhar Subramaniam、Beth Israel Deaconess Medical Center

Safety and Efficacy of Restricted Fluid Regimen in Open Abdominal Bowel Surgery

Liberal intravenous fluid resuscitation during open abdominal surgery may predispose the patients to multiorgan dysfunction, prolong hospital stay and increase postoperative morbidity. The main aim of the study is to assess the safety and feasibility of restricted fluid regimen in open abdominal bowel surgery.

研究概览

详细说明

This is a randomized, prospective controlled trial in patients (ASA I-III) undergoing open abdominal surgical procedures in a single center. This study will be done in two phases. The first phase is designed to evaluate and prove the safety of restricted fluid regimens in maintaining tissue perfusion using a central venous oximetric catheter and arterial blood gas analysis. In the second phase of the study, we plan to mimic the usual clinical practice without the central venous oximetric catheter and arterial lines (invasive monitors) and the postoperative total morbidity will be compared between the liberal and restricted fluid regimens.

In the first phase of the study, 90 patients coming in for open bowel surgery will be randomized to three groups using a random number generator. All patients will receive a standard bowel prep regimen (Go-Lyte-half a liter the night before surgery). Group A will receive current standard of care (liberal fluid therapy), Group B and C will receive restricted fluid regimens. All patients will receive 500 cc of intravenous fluids (lactated ringers in Group A and B, 6% hetastarch in Group C) in the preoperative holding area to correct preoperative fluid deficits due to fasting and bowel preparation. Patients younger than 18 years, ASA IV or V, pregnant patients, those with coagulopathy, renal insufficiency, unstable angina, unstable congestive heart failure, and those with contraindication to central venous pressure catheter insertion will be excluded from the study.

After instituting anesthesia monitors, patients will be anesthetized with a standard anesthetic regimen. An arterial line and a central venous catheter with oximetric capability will be inserted in all three groups. A baseline blood gas will be drawn to note the base excess, lactate levels and the hematocrit at the start of surgery. Parameters like heart rate, blood pressure, central venous pressure, mixed venous oxygen saturation and arterial oxygen saturation and urine output will be continuously monitored. Both the regimens will be started in the operating room and continued into the postoperative period until they resume their oral intake. Patients in the liberal group will receive (10ml/kg/hr) the current standard of care for bowel surgery whereas those in the restricted group will receive 4ml/kg/hour. Post induction hemodynamic instability will be treated with ephedrine and phenylephrine at the discretion of the anesthesiologist in charge.

Intraoperative treatment of tachycardia, hypotension in both the groups will be treated using a standard fluid regimen algorithm (appendix A). All patients will receive the same postoperative fluid regimens as the current standard of care. Postoperative morbidity evaluation (appendix B) will be done at patient's discharge from the hospital. The data entry will be prospectively done during their hospital stay. The accuracy of the data will be checked by one of the study investigators.

研究类型

介入性

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

    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Beth Israel Deaconess Medical Center

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • ASA physical status I-III patients coming in for open abdominal bowel surgery

Exclusion Criteria:

  • Coagulopathy,
  • Pregnancy,
  • Renal insufficiency,
  • Contraindications for placing a central line,
  • ASA IV and V,
  • Age less than 18years

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:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:restriction
In this group, the fluids will be restricted compared to a standard procedure
fluid restriction
restriction of fluids

研究衡量的是什么?

主要结果指标

结果测量
大体时间
mixed venous oxygen saturation, acid bases, hemodynamics
大体时间:intraoperative period
intraoperative period

次要结果测量

结果测量
大体时间
Wound infection and length of hospital stay
大体时间:during the hospital admission
during the hospital admission

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

  • 首席研究员:Balachundhar Subramaniam, MD、Beth Israel Deaconess Medical Center

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。

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

2008年7月1日

初级完成 (预期的)

2009年7月1日

研究完成 (预期的)

2009年12月1日

研究注册日期

首次提交

2007年4月4日

首先提交符合 QC 标准的

2007年4月4日

首次发布 (估计)

2007年4月5日

研究记录更新

最后更新发布 (实际的)

2017年3月6日

上次提交的符合 QC 标准的更新

2017年3月3日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2006P000144

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.

intraoperative fluid management的临床试验

3
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