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临床试验/NCT01652131
NCT01652131Unknown不适用

Colloid Volume Kinetics in Morbidly Obese Patients Under General Anaesthesia

National Institute of Medical Sciences and Nutrition, Salvador Zubiran1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
12
试验地点
1
主要终点
description of colloid volume kinetics in obese patients after the infusion of Tetrastarch (130/0.4)

研究概览

简要总结

There is no objective evidence of how long intravenous solutions remain inside venous blood vessels after they have been administered, therefore there is no definite guideline of how to administer them in the preoperative setting. Besides, obese patients represent a particular group of subjects as they theoretically with-hold a constant inflammatory response and that would modify the way solutions behave intravenously, that is how long they remain inside.

Having said this, we wish to describe the way colloid solutions behave in this group of patients by taking serial blood samples in 12 obese patients after a colloid infusion, to calculate plasma dilution curves based on hemoglobin dilution and therefore infer the time it remains intravascularly.

All this in the hope this information will help, in the near future, to establish a more objective way to use these solutions and avoid possible complications due to over-administration.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

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

入选标准

  • clinical diagnosis of obesity (IMC >35kg/m2) that will be treated with gastrojejunal laparoscopic bypass

排除标准

  • Renal failure KDOQI >3
  • Cardiac failure NYHA III-IV
  • Allergy to tetrastarch
  • Allergy to any of the anesthetic medication that is to be used in the protocol previously established
  • Patients in which vasoactive drugs are used
  • Patients in which the blood samples are completed.

结局指标

主要结局

description of colloid volume kinetics in obese patients after the infusion of Tetrastarch (130/0.4)

时间窗: 90 minutes after beginning of the infusion

different kinetic parameters will be used to asses the behavior of the colloid solution

次要结局

未报告次要终点

研究者

发起方
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Victoria Hernandez Martinez

M.D.

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

研究点 (1)

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