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临床试验/NCT00284570
NCT00284570已完成不适用

ProCalcitonin in the Pediatric Surgical Patient, Evaluation of a New Marker of Infection

Emory University1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2006年1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
49
试验地点
1

研究概览

简要总结

First, we, the researchers, hope to find out the PCT response to heart surgery in children by taking blood before surgery and each day for four days after surgery. These blood draws will help us figure out the typical Procalcitonin (PCT) response, the normal increase in PCT after heart surgery, and when the PCT level returns to baseline.

Second, we, the researchers, hope to determine the accuracy of PCT as a marker of infection.

Hypothesis

Our hypothesis is that Procalcitonin is superior to other currently used markers of infection and will prove to be a clinically useful tool for evaluation of infection in children following cardiac surgery.

详细描述

In this research study, we want to look at the difficulty in identifying infections in children who have heart surgery. We also want to look at differentiating between actual infections and the normal post-surgery course that patients go through. We use a number of tools in the Intensive Care Unit to pick out children at risk for an infection. These tools are the physical examination, a fever, white blood cell count, and C-reactive Protein (CRP) level. When a patient has an infection, they usually have a fever, have a high white blood cell count, and have an increased CRP level. However, these are not always correct. The identification of infection remains a challenge and the laboratory markers of infection (white blood cell count and CRP) that are used now are not perfect.

A new marker of infection, Procalcitonin (PCT), has been found and has been tested in adults and children. PCT has recently been approved by the Food and Drug Administration (FDA) as a marker of infection. PCT has been shown to be a more accurate marker of infection for some groups of patients.

Prior work on a small number of children shows that PCT increases shortly just from heart surgery itself, even without infection. There is little information published about how accurate PCT is for identifying infection in the child heart population. In order to use PCT in our patients, we need to know what the normal levels of PCT are after surgery. Thus, when an infection does happen, we can identify it. We also need to take PCT levels when patients are thought to have infections. We will then need to watch for an infection over the next few days to see if the PCT level rises and can actually predict the presence an infection.

Goals:

  1. Determine the Procalcitonin response to cardiopulmonary bypass in children undergoing open-heart surgery. Cardiopulmonary bypass causes a pro-inflammatory state in the patient, and associated rise in Procalcitonin. The ability to use PCT as a marker for infection will require knowledge of its typical response to bypass and the time course to return to baseline.
  2. Determine the accuracy of Procalcitonin as a marker of infection, and to compare and contrast these findings with currently used laboratory markers.

研究设计

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

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with congenital heart disease
  • Undergoing cardiopulmonary bypass and cardiac surgery
  • Newborn (full term) to up to 6 years of age

排除标准

  • Premature (less than 37 weeks)
  • 6 years of age or older
  • Intercurrent illness at time of surgery
  • Orthotopic organ transplant recipient
  • Pre-operative extra-corporeal support (ECMO)
  • Acquired heart disease

研究者

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

Kevin O. Maher, MD

Associate Prefessor of Pediatrics

Emory University

研究点 (1)

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