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临床试验/NCT03153306
NCT03153306Unknown4 期

Importance of the Infusion Rate for the Plasma Expanding Effect of 5% Albumin in the Septic Patient

Hainan People's Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
Extravascular lung water (EVLW) before and after fluid resuscitation

研究概览

简要总结

Correction of hypovolemia is an important therapeutic measure,Even though there is no consensus regarding infusion rates, a plasma volume (PV) expander is often given at a fast rate to treat a suspected hypovolemia without delay which can be associated with aggravation of adverse interstitial accumulation of macromolecules and fluid, especially in inflammatory conditions such as sepsis.the smallest possible volumes for PV resuscitation to maintain normovolemia should be used to reduce the risk of simultaneous interstitial fluid accumulation. The investigators tested the hypothesis that a slow infusion rate of a PV expander results in better plasma expansion than a fast infusion rate to patients with severe sepsis or septic shock.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • admitted to the ICU patients with severe sepsis or septic shock (diagnosis according to the 2012 surviving sepsis campaign guidelines)
  • there is low blood pressure (SBP < 90 or mean arterial pressure(MAP) < 65 or the systolic blood pressure is decreased 40 mmHg more than the basic level) or lactic acid or greater for 4 mmol/l
  • the informed consent

排除标准

  • less than 18 years of age
  • more than 80 years old
  • pregnant women
  • albumin allergies
  • the dying patients expected lifetime no more than 24 hours)
  • patient with myocardial infarction, heart failure
  • liver failure
  • refused to sign the informed consent

研究组 & 干预措施

the "bolus" group

Experimental

10ml/kg of the natural colloid 5% albumin was given at 1 hrs.

干预措施: albumin (Drug)

the"continuous" group

Experimental

10ml/kg of the natural colloid 5% albumin was given over 6 hrs

干预措施: albumin (Drug)

结局指标

主要结局

Extravascular lung water (EVLW) before and after fluid resuscitation

时间窗: 6 hour

Extravascular lung water (EVLW)is measured by Pulse index continous cardiac output (PICCO) before and after fluid resuscitation in each group

次要结局

未报告次要终点

研究者

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

rui li

Attending Doctor, critical care medicine department

Hainan People's Hospital

研究点 (1)

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