跳至主要内容
临床试验/NCT01194492
NCT01194492已完成4 期

Albumin Kinetics in Generalized Inflammation - an Exploratory Study on Patients Before and After Major Abdominal Surgery

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
10
试验地点
2
主要终点
Change from baseline in albumin transcapillary escape rate

研究概览

简要总结

The purpose of this study is to determine whether the kinetics of endogenous albumin is altered by the generalized inflammation caused by major abdominal surgery.

详细描述

Albumin infusions have been used for expansion of the plasma volume for more than 60 years, not only in the operating room, but also in trauma and sepsis. However, there is an ongoing debate whether albumin is good or bad for the patient compared to other intravenous fluids, in different situations. Our research program aims at exploring this issue, starting by describing how the body handles the endogenous albumin in connection with severe inflammation. The final goal is to improve fluid treatment for these patients.

Plasma albumin is often decreased in inflammation. However, the underlying mechanisms are not well described. Two aspects of albumin kinetics will be covered in this study by measurements immediately before and two days after major abdominal surgery, that will serve as a model for generalized inflammation. Albumin fractional synthesis rate will be determined by the incorporation of deuterium labelled phenylalanine into plasma albumin. Albumin distribution will be measured as transcapillary escape rate of radioiodinated albumin. By assessment of P-albumin and plasma volume it will be possible to calculate albumin absolute rate of synthesis and albumin absolute flux from the central compartment, respectively.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • written informed consent
  • patients planned for major abdominal surgery, pancreatic
  • age ≥ 40 years

排除标准

  • pregnant or lactating patients
  • planned peri-operative infusions of albumin or plasma
  • S-creatinine > 110 mmol/L
  • allergy against iodine
  • other conditions preventing the subject from participating in the study, as judged by the investigator

结局指标

主要结局

Change from baseline in albumin transcapillary escape rate

时间窗: 2 days

Transcapillary escape rate is measured as the rate of decrease of 125I-albumin in plasma over 90 min. The assessment is performed twice, immediately before surgery and in the second post-operative day, respectively.

Change from baseline in albumin synthesis rate

时间窗: 2 days

次要结局

  • Changes from baseline in markers of inflammation (heart rate, respiratory rate, body temperature, Blood leukocyte count, and P-CRP)(2 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ake Norberg

MD PhD

Karolinska Institutet

研究点 (2)

Loading locations...

相似试验