Development of a Biological Database in the Field of Operative Intensive Care for the Recording of Clinically Relevant Parameters of Critically Ill Intensive Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- RWTH Aachen University
- Enrollment
- 99,999,999
- Locations
- 1
- Primary Endpoint
- Interleukin 6 value [nmol/l]
Study Overview
Brief Summary
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.
Detailed Description
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)
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Interleukin 6 value [nmol/l]
Time Frame: 10 days
Record of clinically relevant parameters
Procalcitonin [nmol/l]
Time Frame: 10 days
Record of clinically relevant parameters
Interleukin 10 [nmol/l]
Time Frame: 10 days
Record of clinically relevant parameters
Adrenomedullin value [nmol/l]
Time Frame: 10 days
Record of clinically relevant parameters
Tumornekrosefaktor alpha [nmol/l]
Time Frame: 10 days
Record of clinically relevant parameters
Secondary Outcomes
No secondary outcomes reported