跳至主要内容
临床试验/NCT03014427
NCT03014427招募中不适用

Development of a Biological Database in the Field of Operative Intensive Care for the Recording of Clinically Relevant Parameters of Critically Ill Intensive Patients

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 99,999,999 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
99,999,999
试验地点
1
主要终点
Interleukin 6 value [nmol/l]

研究概览

简要总结

The storage and use of biomaterial samples is an important requirement for accompanying research and the acquisition of new knowledge to improve prognosis and therapy. Biobanking is explicitly recommended in official guidelines. In order to preserve the biomaterial, the patient must consent to the removal, transfer and storage of the biomaterial separately from the consent to the register. The biomaterial is taken at times at which a blood or urine sampling takes place anyway in the clinical routine. Therefore no additional interventions are necessary.

详细描述

The storage and use of biomaterial samples is an important requirement for accompanying research and the acquisition of new knowledge to improve prognosis and therapy. Biobanking is explicitly recommended in official guidelines. In order to preserve the biomaterial, the patient must consent to the removal, transfer and storage of the biomaterial separately from the consent to the register. The biomaterial is taken at times at which a blood or urine sampling takes place anyway in the clinical routine. Therefore no additional interventions are necessary.

Sample volumes are defined as follows:

  • Peripheral blood: up to a total of 150 ml distributed to a maximum of 10 morning blood samples (approximately 15 ml blood per blood sample) during the inpatient stay in the intensive care unit (fixed times are admission and discharge of the intensive care unit)
  • Urine: a total of up to 200 ml of catheter urine distributed to a maximum of 10 morning withdrawals during inpatient stays in the intensive care unit (defined times are admission and discharge from the intensive care unit)

研究设计

研究类型
Observational
观察模型
Other
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

  • patients after admission to the intensive care unit
  • 18 years or older
  • signed informed consent

排除标准

  • No exclusion criteria are formulated with regard to the objective of the register to record intensive care patients in general. Patients with multiple comorbidities, organ dysfunctions, and non-compliance for a curatively-intended therapy should also be recorded in the register. A palliative treatment or decision for best supportive care is not an exclusion criterion for registering.

结局指标

主要结局

Interleukin 6 value [nmol/l]

时间窗: 10 days

Record of clinically relevant parameters

Procalcitonin [nmol/l]

时间窗: 10 days

Record of clinically relevant parameters

Interleukin 10 [nmol/l]

时间窗: 10 days

Record of clinically relevant parameters

Adrenomedullin value [nmol/l]

时间窗: 10 days

Record of clinically relevant parameters

Tumornekrosefaktor alpha [nmol/l]

时间窗: 10 days

Record of clinically relevant parameters

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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