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临床试验/NCT00563030
NCT00563030已完成不适用

Comparison of Granulocyte Subsets in Peripheral Blood After Coronary Bypass Grafting Operations With and Without Use of Cardiopulmonary Bypass

Medical University of Gdansk1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
percentage of immature forms of neutrophils in peripheral blood

研究概览

简要总结

Coronary artery bypass graft (CABG) surgery is associated with reperfusion syndrome and activation of inflammatory reaction (SIRS). These are more exaggerated when cardiopulmonary bypass (CPB) is used.

The aim of the study is to compare signs of SIRS (heart rate, tachypnea or hypocarbia, leukocytosis, hyperpyrexia or hypothermia) and the granulocytes subsets in peripheral blood from patients who underwent CABG surgery with or without use of CPB.

The researchers expect significant differences in SIRS criteria between both groups. If the differences will occur significant, the parameter may be used as candidate variable for a complications prediction model after CABG surgery.

详细描述

Patients fulfilling inclusion criteria will be asked to sign the consent to participate in the study, the day before operation after routine preoperative anesthesiological evaluation. If included into the study they will be assigned to one of the two study groups - off-pump CABG, or CABG with CPB.

After arrival into the operating theatre 4.5 ml blood will be obtained into EDTA vials from a peripheral venous canula, placed previously for routine anesthesiologic management.

Additional blood samples will be obtained 3, 6, 12, 24 and 48 hours after the operation. Each vial will be immediately labeled with an identification number and submitted into the laboratory, where smear with May-Grunwald-Giemsa staining will be prepared. The smear will be panoptical examined for 400 consecutive leucocytes and assigned to one of the following lines: neutrophils, eosinophils, basophils, monocytes and lymphocytes. Neutrophils will be further divided into: segments, bands, metamyelocytes, myelocytes, promyelocytes, myeloblasts.

The laboratory staff will be blinded for type of operation. Differences in subsets of granulocytes between groups and timepoints wil be analysed as means by appropriate parametric or nonparametric statistical tests.

The SIRS criteria will be refered to:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Elective or urgent CABG with CPB or without (off-pump CABG)
  • Signed informed consent

排除标准

  • Denied consent
  • Signs of infection and/or inflammation (at least 2/4 SIRS criteria)
  • Emergency operation
  • Organ failure/dysfunction

结局指标

主要结局

percentage of immature forms of neutrophils in peripheral blood

时间窗: first 48 hours after operation

次要结局

  • clinical signs of SIRS: heart rate, temperature, pCO2, respiratory rate (as applicable), total white blood cells(first 48 hours after operation)

研究者

申办方类型
Other

研究点 (1)

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