跳至主要内容
临床试验/NCT02556580
NCT02556580Unknown4 期

Volume Kinetics for 20% Albumin in Conscious and Anesthetized Humans With and Without Inflammation

Sodertalje Hospital2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
45
试验地点
2
主要终点
Degree of plasma volume expansion

研究概览

简要总结

The study aims to determine the degree of plasma volume expansion and the half-life of the plasma volume expansion when 3 mL/kg of hyperoncotic (20%) albumin if infused over 30 minutes in conscious healthy volunteers, in patients undergoing surgery under general anesthesia, and on the day after major surgery when the patient is in a post surgical inflammatory state. The study also examines the increase in the plasma colloid osmotic pressure as a result of this infusion and its possible influence on markers of kidney damage.

详细描述

15 volunteers, 15 patients undergoing surgery and 15 patients in the post-surgical phase will be recruited for this study because they have different degrees of vasodilatation and inflammation, which are factors of potential importance to the effectiveness of plasma volume expansion with albumin 20%. Hyperoncotic albumin should logically recruit fluid from the interstitial fluid space, but this possibility has recently been questioned in the "revised Starling equation".

The degree of plasma volume expansion and also the half-life will be estimated by population volume kinetics which uses serial analyses of the blood hemoglobin concentration and a summary measure of the excreted urine during the 5-hour experiment to calculate these outcome measures.

There is a risk that hyperoncotic solutions cause pre-renal anuria due to the rise in plasma oncotic pressure. As a safety measure we will assess the plasma oncotic pressure and relevant biomarkers of renal function during the experiments. The experiments will be ended with a slow infusion of 1 L of Ringer´s acetate to dilute any raised oncotic pressure.

研究设计

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

入排标准

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

入选标准

  • Healthy volunteers.
  • Patients in ASA classes I-II scheduled for surgery.

排除标准

  • Expected major hemorrhage during surgery.
  • Blood hemoglobin concentration of < 10 g/dL.

研究组 & 干预措施

Conscious healthy volunteers

Active Comparator

Intervention: intravenious infusion Drug: albumin 20%

干预措施: Albumin 20% (Drug)

Surgery under general anesthesia

Experimental

Intervention: intravenious infusion Drug: albumin 20%

干预措施: Albumin 20% (Drug)

Post-surgical inflammation

Experimental

Intervention: intravenious infusion Drug: albumin 20%

干预措施: Albumin 20% (Drug)

结局指标

主要结局

Degree of plasma volume expansion

时间窗: 5 hours

Calculated by volume kinetics

次要结局

  • Increase in plasma oncotic pressure(5 hours)
  • Possible effect on biomarkers of kidney injury(5 hours)
  • Half-life of plasma volume expansion(5 hours)

研究者

发起方
Sodertalje Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Hahn

Research Dircetor

Sodertalje Hospital

研究点 (2)

Loading locations...

相似试验

Volume Kinetics for 20% Albumin in Different... | 临床试验