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临床试验/NCT01296074
NCT01296074已完成不适用

The Perioperative Effect of Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response

Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
recovery of monocyte subsets

研究概览

简要总结

To observe the effect of glucocorticoid on the dynamic changes of monocyte subsets in the peripheral blood of valve disease patients undergoing cardiopulmonary bypass perioperatively.

详细描述

Systemic inflammatory response syndrome (SIRS) is a common major complication of cardiopulmonary bypass. "Emergency Hematopoiesis" is the pathological process induced by the inflammation. The investigators previously confirmed that emergency hematopoiesis induced by cardiopulmonary bypass led to dynamic changes of quantities of monocyte subsets, there is a significant increase in the number of two monocyte subsets: 1) CD14highCD16+ monocyte with strong immunomodulatory activity; 2) CD14lowCD16- monocyte with potential ability of proliferation and differentiation. Therefore, a new hypothesis risen: "the change of the function and the number of monocyte subsets induced by emergency hematopoiesis play an important role for SIRS occurrence after cardiopulmonary bypass, correcting emergency hematopoiesis is a new breakthrough in the prevention and treatment of SIRS." To identify the mechanism of function changed in different monocyte subsets during the pathogenesis of SIRS, the research intended to target perioperative-period patients with heart valve replacement, monitor dynamically the number and phenotype of peripheral blood monocyte subsets by flow cytometry; sort out of different monocyte subsets for cell culture in vitro, observe the ability of proliferation and differentiation and effects between monocyte subsets and T lymphocyte; investigate the mechanism of immune function changes with antibody-blocking and compartment culture in patients; observe the impact of glucocorticoid treatment on the emergency hematopoiesis, offer new objects for evaluation of immune status in patients and provide new evidence for anti-inflammatory therapy .

Patients should be follow the protocol of cardiopulmonary bypass according to normal hospital routine practice.

A total of 30 patients will be enrolled in this clinical trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Valve replacement under cardiopulmonary bypass

排除标准

  • Cardiopulmonary bypass time over 120 minutes
  • Hyperlipidemia
  • Diabetes mellitus
  • Autoimmune diseases

研究组 & 干预措施

Corticosteroid

Experimental

Methylprednisolone will be given during cardiopulmonary bypass.

干预措施: Corticosteroid (Drug)

结局指标

主要结局

recovery of monocyte subsets

时间窗: baseline, day1, 3, 5, 7 postoperative

Changes in monocyte subsets in cardiopulmonary bypass patients were found.After 1w-2w postoperatively, it would recover to the preoperative level.

次要结局

未报告次要终点

研究者

发起方
Beijing Anzhen Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaotong Hou

Chief of Center for Cardiac Intensive Care

Beijing Anzhen Hospital

研究点 (1)

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