Development of a Biological Database in the Field of Operative Intensive Care (Biobank OIM)
Development of a Biological Database in the Field of Operative Intensive Care for the Recording of Clinically Relevant Parameters of Critically Ill Intensive Patients
研究概览
详细说明
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)
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Christina Kalvelage, M. Sc.
- 电话号码:0241 80 36485
- 邮箱:ckalvelage@ukaachen.de
研究联系人备份
- 姓名:Christian Stoppe, Dr. med.
- 电话号码:0241 80 36575
- 邮箱:cstoppe@ukaachen.de
学习地点
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Aachen、德国、52074
- 招聘中
- Uniklinik RWTH Aachen
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接触:
- Christian Stoppe, PD Dr. med.
- 邮箱:cstoppe@ukaachen.de
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- patients after admission to the intensive care unit
- 18 years or older
- signed informed consent
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 观测模型:其他
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Interleukin 6 value [nmol/l]
大体时间:10 days
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Record of clinically relevant parameters
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10 days
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Interleukin 10 [nmol/l]
大体时间:10 days
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Record of clinically relevant parameters
|
10 days
|
Adrenomedullin value [nmol/l]
大体时间:10 days
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Record of clinically relevant parameters
|
10 days
|
Tumornekrosefaktor alpha [nmol/l]
大体时间:10 days
|
Record of clinically relevant parameters
|
10 days
|
Procalcitonin [nmol/l]
大体时间:10 days
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Record of clinically relevant parameters
|
10 days
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合作者和调查者
调查人员
- 首席研究员:Christian Stoppe, Dr. med.、Operative Medicine and Intensive Care, RWTH Aachen University
出版物和有用的链接
一般刊物
- Bestehorn K. [Medical registries]. Med Klin (Munich). 2005 Nov 15;100(11):722-8. doi: 10.1007/s00063-005-1098-x. German.
- Schott G, Berthold HK. Pharmakovigilanz: Empfehlungen zur Meldung unerwünschter Arzneimittelwirkungen durch die Ärzteschaft. Arzneiverordnung in der Praxis. 2005.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 16-151
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Biological Database的临床试验
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GlaxoSmithKline完全的
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GlaxoSmithKline完全的
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GlaxoSmithKlineThe PATH Malaria Vaccine Initiative (MVI)完全的