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