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临床试验/NCT01801501
NCT01801501已完成不适用

Role of FGF-23 as a Prognosis Biomarker in Intensive Care Patients

University of Chile1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
164
试验地点
1
主要终点
Overall survival

研究概览

简要总结

The purpose of the study is to evaluate the potential role of plasmatic Fibroblast Growth Factor 23 (FGF-23) as a prognosis predictor of clinical outcomes in Critical Care patients.

详细描述

Observational study of patients admitted in the Critical Care Unit (CCU) of University of Chile Clinical Hospital, admitted with diagnosis of severe sepsis/septic shock.

Exclusion criteria: Pregnancy, organ transplantation. Informed consent is solicited to patients before admission in study. If the patient cannot give it because of his/her clinical condition, it will be solicited to a patient representative.

After admission in CCU and achievement of informed consent, a venous blood sample will be obtained, to determinate plasmatic levels of Fibroblast Growth Factor 23 (FGF-23). New samples will be obtained at 24 and 48 hours after admission. Determination of FGF-23 will be performed by ELISA technique in Integrated Physiology laboratory.

Demographics, clinical and biochemical data will also be obtained. The data will be collected by the Principal Investigator. Confidentially of all data will be preserved during and after the completion of the study.

The study is divided in 2 parts:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 89 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admission in Critical Care Unit

排除标准

  • Pregnancy
  • Organ transplantation

结局指标

主要结局

Overall survival

时间窗: 30 days and 1 year

Determination of overall survival during the first 30 days and 1 year after admission

次要结局

  • Duration of hospitalization(30 days)

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luis Toro

Physician

University of Chile

研究点 (1)

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