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Starch or Saline After Cardiac Surgery (SSACS)

2019年8月13日 更新者:Dave Nagpal、London Health Sciences Centre

Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial

When people undergo major surgery, they require intravenous supplementation of fluids for a number of reasons:

  • to compensate for no oral intake
  • to support blood pressure and organ function during and after surgery
  • to replace lost fluid or blood volume

There are a variety of fluid choices doctors have to provide to patients, and it is still not definitively known whether some fluids are better than others in specific situations. This is a particularly interesting question in patients undergoing heart surgery because of the significant volume of fluids used over the entire course of hospitalization, including before the operation, during the operation, and after the operation.

There has been some scientific evidence that the use of starch-based fluids (synthetic colloids) leads to better oxygen delivery to the organs with a smaller volume of fluid given, providing for better recovery from surgery. However, there has also been some scientific evidence that the use of these fluids can harm kidney function. Importantly, none of these large-scale studies were carried out specifically in patients undergoing heart surgery.

The purpose of this study is to answer the question of whether the use of starch-based fluid in the heart surgery patient makes for a safer and faster recovery, causes kidney dysfunction, or makes no discernable difference.

研究概览

研究类型

介入性

注册 (实际的)

69

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

    • Ontario
      • London、Ontario、加拿大、N6A 5A5
        • London Health Sciences Centre

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:

  • patients undergoing elective primary isolated on-pump coronary artery bypass grafting

Exclusion Criteria:

  • pregnant patients
  • patients with an active intra-cranial bleed
  • patients with a history of hypersensitivity to starch solutions
  • patients with Stage 4 or 5 Kidney Disease (estimated glomerular filtration rate < 30 ml / min / 1.73 m2)
  • patients with a significant preoperative metabolic acidosis, defined by a preoperative capillary blood pH less than or equal to 7.2 and a serum bicarbonate less than 15

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:Starch group
Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements.
有源比较器:Saline group
Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Incidence of acute kidney injury as defined by RIFLE criteria
大体时间:Short term (in hospital, up to 30 days) and mid-term (2 months)
Short term (in hospital, up to 30 days) and mid-term (2 months)
Maximum postoperative weight gain
大体时间:Short-term (in hospital, up to 7 days)
Short-term (in hospital, up to 7 days)

次要结果测量

结果测量
大体时间
Operative mortality
大体时间:In hospital (up to 30 days)
In hospital (up to 30 days)
Duration of ventilation support requirements
大体时间:In hospital (up to 30 days)
In hospital (up to 30 days)
Total chest tube drainage (until removed)
大体时间:In hospital (up to 30 days)
In hospital (up to 30 days)
ICU length of stay
大体时间:In hospital (up to 30 days)
In hospital (up to 30 days)
Transfusion of blood products
大体时间:In hospital (up to 30 days)
In hospital (up to 30 days)
Incidence of atrial fibrillation (necessitating a change in medical management)
大体时间:In hospital (up to 30 days)
In hospital (up to 30 days)
Duration of oxygen supplementation
大体时间:In hospital (up to 30 days)
In hospital (up to 30 days)
Creatinine, Urea, Cr Clearance as estimated by the MDRD formula
大体时间:In hospital at defined timepoints, and at 2 months post hospital discharge
In hospital at defined timepoints, and at 2 months post hospital discharge
Volume of fluid infused
大体时间:In hospital (up to 7 days)
In hospital (up to 7 days)
Total hospital length of stay (when ready to leave tertiary hospital setting)
大体时间:In hospital
In hospital

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:Dave Nagpal, MD、LHSC / UWO
  • 首席研究员:Ray Guo, MD、LHSC / UWO
  • 首席研究员:Chris Harle, MD、LHSC / UWO

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)

2009年8月1日

初级完成 (实际的)

2010年6月1日

研究完成 (实际的)

2012年6月1日

研究注册日期

首次提交

2009年8月20日

首先提交符合 QC 标准的

2009年8月21日

首次发布 (估计)

2009年8月24日

研究记录更新

最后更新发布 (实际的)

2019年8月15日

上次提交的符合 QC 标准的更新

2019年8月13日

最后验证

2019年8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.

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