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临床试验/NCT02755155
NCT02755155终止4 期

Comparison of 2 Strategies of Therapeutic Human Serum Albumin Infusion in Critically Ill Patients With Severe Systemic Inflammatory Response Syndrome and Low Plasma Albumin: Continuous Low Versus Intermittent High Doses

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
138
试验地点
1
主要终点
Mortality

研究概览

简要总结

Primary purpose : mortality at Day 28

Secondary purposes :

  • Daily SOFA (Sequential Organ Failure Assessment) score lessening within Intensive Care Unit (ICU)
  • Duration of increasing doses of norepinephrine infusion to maintain target mean arterial pressure
  • Number of care-related infections within ICU

详细描述

According to currently available literature on therapeutic albumin infusion in critically ill patients, there is room for new approaches to delineate an optimal use of this expansive treatment. Indeed, many authors suggest that the present clinical use of albumin is questionable in critically ill patients as far as changes in morbidity or mortality are concerned and with regards to cost-effectiveness.

It has been reported that protein misfolding and aggregation are a hallmark of several inflammatory diseases. In vitro studies show that very small amounts of albumin are able to restore the physiologic activities of endogenous circulating proteins that had been aggregated in multimeric form during oxidative stress. Recently, the investigators have reported that in vitro albumin restores antimicrobial and anti-inflammatory effects of some chromogranin A-derived peptides. The investigators therefore search to test in vivo, in critically ill patients with severe systemic inflammation requiring norepinephrine infusion, whether therapeutic albumin infused at a low and continuous dosage may modify mortality (primary purpose) and morbidity (secondary purposes) in comparison with intermittent high dosage albumin infusion.

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

入选标准

  • •circulatory failure requiring norepinephrine support (any dose)
  • •hospitalization within an Intensive Care Unit
  • •low plasma albumin (< 20g/L)
  • •consent to study

排除标准

  • •absence of circulatory failure
  • •absence of SIRS
  • •chronic low albumin concentration
  • •absence of consent to study
  • •inability to tolerate human serum albumin
  • •Patients under guardianship or curators
  • •Women pregnant

研究组 & 干预措施

Continuous low dosage (CLD)

Experimental

The subjects will received human serum albumin infusion 4%.CLD patients are infused with15ml/kg/day of 4% human serum albumin from inclusion to the day norepinephrine infusion is weaned by 30% (provided their plasma albumin stays in the range 30+3g/L)

干预措施: Human serum albumin infusion 4% (Drug)

Intermittent high dosage (IHD)

Active Comparator

The subjects will received human serum albumin infusion 20%.IHD patients are infused with 20% human serum albumin (up to 600 ml/day) until the plasma albumin concentration is in the range 30+3g/L from inclusion to the day norepinephrine infusion is weaned by 30%

干预措施: Human serum albumin infusion 20% (Drug)

结局指标

主要结局

Mortality

时间窗: 28 days after inclusion between the two groups

次要结局

  • The length of the circulatory failure requiring albumin infusion(The estimated period of time will be from date of baseline visit until the date of discharge from the hospital or date of death from any cause, whichever came first, assessed up to 28 days)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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