跳至主要内容
临床试验/NCT01184430
NCT01184430Unknown不适用

Monocentric Pilot Study of Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
HLA-DR Expression on monocytes after surgery

研究概览

简要总结

Cardiac surgery patients have a high risk to suffer from postoperative infections. Some studies have shown, that humoral and cellular factors are associated with perioperative immunodysfunction and can increase the risk of postoperative infections. Monocytes in the blood and, especially alveolar macrophages are important for an adequate host defence. In studies the investigators have shown that hemodynamic parameters have a significant influence on the probability to develop postoperative infections. The aim of the study is to investigate, whether cardiac surgery patients have an altered immune function after surgery that is predictive for the latter development of subsequent infections and whether they benefit from a goal-directed volume and hemodynamic therapy.

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

  • •elective cardiac surgery patient undergoing cardiopulmonary bypass
  • •signed informed consent

排除标准

  • •pregnant or breast feeding women
  • •Age <18 years
  • •pulmonary disease with an oxygenation index <300mmHg
  • •liver disease (>Child B)
  • •HIV-Infection
  • •Therapy with corticosteroids
  • •Condition after transplantation
  • •preexisting infection before operation

研究组 & 干预措施

advanced hemodynamic monitoring

Active Comparator

advanced hemodynamic monitoring with pulse contour analysis ( LiDCO rapid) and goal-directed therapy

干预措施: Pulse contour cardiac output device (Device)

standard monitoring

No Intervention

hemodynamic monitoring based on the standard operating procedures of our clinic

结局指标

主要结局

HLA-DR Expression on monocytes after surgery

时间窗: 24 hours

次要结局

  • ICU stay(24 hours)

研究者

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

Michael Sander

Vice Chair

Charite University, Berlin, Germany

研究点 (1)

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