跳至主要内容
临床试验/NCT03441035
NCT03441035Unknown不适用

Albumin Mass Balance in Liver Transplantation, an Open Prospective Cohort Study

Ake Norberg1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年3月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Cumulative perioperative shift of albumin

研究概览

简要总结

This clinical observational cohort study assess the loss of albumin from blood circulation during and after liver transplantation by mass balance of albumin. The overall assumption of this method is that if albumin is more diluted than hemoglobin, it must have left the plasma, presumably into the interstitial space. Predictors of albumin leakage will be assessed, including biomarkers of inflammation and of endothelial damage and dysfunction. The sub cohorts children and patients with complications, defined as prolonged postoperative treatment in the intensive care unit, respectively, will be focused in separate publications.

详细描述

Background Capillary leakage has been recognized to be associated with surgery and inflammation [Fleck 1985]. In liver transplantation considerable amounts of exogenous albumin is administered to support circulatory stability and a post operative plasma albumin concentration of 25 g/L to facilitate interpretation of immuno suppressive drug concentrations. However, the long term effects of exogenous albumin is not well characterized in the literature, and extravasation might promote edema formation and impair wound healing. In previous studies we have demonstrated the ability of the albumin mass balance method to identify leakage of albumin in major abdominal surgery [Norberg 2016].

In a pilot study in patients undergoing liver transplantation (n=11) we found a net leakage of albumin from plasma of 37 ± 17 g at end of surgery and 48 ± 33 g at postoperative day 3.

The primary aim of the new study is to find if this net leakage is still there at postoperative day 7. We are also looking into predictors of positive albumin shift from plasma including markers of inflammation and endothelial injury or dysfunction. Focus will also be put on the subgroup of children during and after liver transplantation. Finally a subgroup of patients in need of prolonged ICU stay after liver transplantation will be investigated to see the prolonged effects of our present routines, and these patients ability to synthetize albumin.

All patients undergoing liver transplantation at Karolinska University Hospital are eligible.

Recruitment will be made in advance as soon as patients are put on the transplant waiting list. In adults, at the day of surgery, blood samples will be taken repeatedly for estimation of plasma albumin. In all patients we will keep track of any gains or losses of albumin or hemoglobin in suction bottles, drains, exogenous blood products, exogenous albumin etc. This sampling will proceed during the study period that will end at hospital discharge or not later than post-operative day 21. Adult patients that are still in the ICU on postoperative day 3 will be subjected to a measurement of albumin synthesis rate by the flooding method [Ballmer 1993]. All subjects, even children, will have blood sampled for ELISAs of markers of inflammation and endothelial injury or dysfunction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients undergoing liver transplantation are eligible

排除标准

  • No consent Unability to understand the study information (language or consciousness)

结局指标

主要结局

Cumulative perioperative shift of albumin

时间窗: Post-operative day 7 after liver transplantation

By mass balance of albumin (i.e keeping track of all gains and losses of albumin and compare these to hemoglobin) it is possible to estimate the loss of albumin from plasma that is not explained by losses in bleeding or drains.

次要结局

  • Predictors of prolonged need for ICU stay(from pre-operative risk assessment until post-operative day 21)
  • Albumin synthesis rate(postoperative days 3-21 after liver transplantation)
  • Cumulative perioperative shift of albumin in children(during and after liver transplantation until postoperative day 21)
  • Predictors of cumulative perioperative shift of albumin(from pre-operative risk assessment until post-operative day 7)

研究者

发起方
Ake Norberg
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ake Norberg

Associate professor, Senior Consultant

Karolinska Institutet

研究点 (1)

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