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临床试验/NCT00683007
NCT00683007已完成不适用

Use of Transesophageal Echocardiography to Assess Left Ventricular Performance During Acute Normovolemic Hemodilution and Randomized Replacement With Intravenous Crystalloid or Hypertonic Saline

University of California, Davis1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2011年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
TE echo LV 3-D volume changes.

研究概览

简要总结

The purpose of this study is to examine how the heart functions when a calculated amount of blood is removed and how two fluids, Lactated Ringer's (considered the standard replacement fluid) and Hypertonic Saline, re-expand the vascular system.

详细描述

This investigator-initiated, single-center, prospective, randomized, clinical experimental design will enroll 30 patients scheduled for elective radical prostatectomy, cystectomy, or cystoprostatectomy, and anterior/posterior spinal fusions, which includes routine acute normovolemic hemodilution (ANH) as a technique to decrease the need for banked blood transfusions. The purpose of this study is to compare two methods of volume replacement during the ANH procedure. Patients will be randomized to receive either standard crystalloid replacement with Lactated Ringers (LR) or 5% hypertonic saline. Selected measurements will be obtained by transesophageal echocardiography (TEE) for assessing changes in left ventricular volume and function associated with blood loss and replacement. This study will use the Accuson Cypress Cardiovascular System and the V5M transesophageal echocardiography probe (Siemens Medical Solutions, Malvern, PA). The TEE measurements will be recorded on magnetic optical discs and assessed off-line by the researcher after the data collection is completed using the proprietary software included in the ultrasound system. In addition, stroke volume variation measurement (SVV), Cardiac Output (CO), Cardiac Index (CI), and Stroke Volume Index (SVI) will be measured using the Vigileo (TM) arterial pressure monitor with the FloTrac (TM) sensor (Edwards Lifesciences, Irvine, CA).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
17 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Elective surgical patients requiring acute normovolemic hemodilution

排除标准

  • •Contraindication for hemodilution
  • •Contraindication for TE echo

研究组 & 干预措施

2

Active Comparator

Hypertonic Saline

干预措施: Volume resuscitation (Hypertonic Saline Solution) (Other)

1

Active Comparator

Crystalloid

干预措施: Volume resuscitation (Crystalloid) (Other)

结局指标

主要结局

TE echo LV 3-D volume changes.

时间窗: 1 hour

次要结局

  • APCO system changes.(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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