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临床试验/NCT00426192
NCT00426192Unknown4 期

Mechanisms of Endotoxin-Tolerance of Human Monocytes After CABG-Sugery - Effects of Hemofiltration and Mannitol Treatment

University Hospital, Saarland1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2003年10月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
发起方
入组人数
52
试验地点
1
主要终点
LPS-stimulated cytokine release

研究概览

简要总结

After cardiac surgery with cardiopulmonar bypass, the LPS-stimulated cytokine response has been previously shown to be depressed. Therefore, in this trial the hypothesis was tested, whether simple immunomodulting interventions like the i.v. adminstration of mannitol of hemofiltration during cardipulmonary bypass can attenuate this immunosuppressing effect.

详细描述

Background Cardiac surgery using cardiopulmonary bypass (CPB) causes a systemic inflammatory response. In addition to this immune response to CPB, a significant impairment of the responsiveness of peripheral blood mononuclear cells (PBMC) to further immunological stimuli has been observed. The aim of our present study was to evaluate the ability of antioxidant therapy with mannitol or hemofiltration during CPB to modulate the observed immunosuppression after CPB.

Methods With ethics committee approval, 52 patients undergoing elective CABG-surgery were prospectively enrolled and randomized into 3 groups (control, 50 g mannitol iv, hemofiltration during CPB). Blood samples were taken after induction of anesthesia (T1), 20 min after separation from CPB (T2) and 24 h postoperatively (T3). Expression density of the monocytic surface receptor CD14, HLA-DR expression and cytokine release (TNF- and IL10) after LPS-stimulation were evaluated.

Results At T2, the CD14dim cell population was maintained in both intervention groups while in the control group there was a significant decrease of this proinflammatory monocytic phenotype. At T3, all groups developed a significant shift towards the antiinflammatory CD14bright population. No significant differences regarding HLA-DR expression or cytokine release could be demonstrated.

Conclusion This study shows that the suppression of the stimulated immune response after CPB can be alleviated by iv administration of mannitol or hemofiltration. In the light of data showing that this depression of the immune response might affect the postoperative course of patients, these results could lead to an improvement of the management of patients undergoing cardiac surgery with CPB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •male patients
  • •aged 35-80
  • •elective CABG surgery

排除标准

  • •previous cardiac surgery
  • •ejection fraction < 40%
  • •valvular heart disease
  • •myocardial infarction during the last 3 months
  • •evidence of concomitant malignant or immunologic diseases
  • •antecedent medication with corticosteroids or methylxanthines
  • •hemoglobin < 12 g/dl
  • •body mass index > 30

结局指标

主要结局

LPS-stimulated cytokine release

LPS-stimulated CD14 exppression density

次要结局

未报告次要终点

研究者

发起方
University Hospital, Saarland
申办方类型
Other

研究点 (1)

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