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临床试验/NCT01397188
NCT01397188Unknown不适用

Effect of Monitoring of Pulse Index Continuous Cardiac Output on Shock Patients in ICU

Li danyang1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
320
试验地点
1
主要终点
mortality at 28 days

研究概览

简要总结

PiCCO has become a widely used haemodynamic monitoring device in the management of shock patients in ICU patients nowadays. But the effects on outcome of use of Picco, such as hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical ventilation-free days and change of lactate and BNP in shock patients has not been determined. Patients will be randomly assigned to a Picco group or the control group, hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical ventilation-free days and change of lactate and BNP will be observed. The conclusion will supply evidence for the clinical effectiveness of Picco in shock patients.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • critically ill patients with shock: Mean arterial pressure (MAP) < 65 mmHg (< 8,7 kPa) or systolic arterial pressure (SAP) < 90 mmHg (< 12 kPa) or the need for vasopressor (Norepinephrine <0.05µg/kg/min) to support the MAP ≥ 65 mmHg (≥ 8,7 kPa) or the SAP ≥ 90 mmHg ≥ 12 kPa), when one of these criteria has lasted for 4 hours or longer

排除标准

  • Age < 18 years
  • Age > 85 years
  • Pregnancy (positive pregnancy test in women of child bearing age)

结局指标

主要结局

mortality at 28 days

时间窗: 28 days

mortality at 28 days after diagnosis of shock

次要结局

  • vasoactive agents-free days(28 days)
  • intensive care unit-free days(28 days)
  • mechanical ventilation-free days(28 days)
  • the change of lactate at 1,3,7 days after the insertion of the Picco catheter(7 days)
  • the change of B-Type Natruetic Peptide(BNP) at 1,3,7 days after the insertion of the Picco catheter(7 days)
  • mortality at 90 days(90 days)

研究者

发起方
Li danyang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Li danyang

Dr

Zhejiang University

研究点 (1)

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