Clinical trial NCT03014427: Development of a Biological Database in the Field of Operative Intensive Care
Official title: Development of a Biological Database in the Field of Operative Intensive Care for the Recording of Clinically Relevant Parameters of Critically Ill Intensive Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intensive Care in General
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 99999999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: intensive care patients in general

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Interleukin 6 value [nmol/l]
timeFrame: 10 days
measure: Interleukin 10 [nmol/l]
timeFrame: 10 days
measure: Adrenomedullin value [nmol/l]
timeFrame: 10 days
measure: Tumornekrosefaktor alpha [nmol/l]
timeFrame: 10 days
measure: Procalcitonin [nmol/l]
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
Study officials:
affiliation: Operative Medicine and Intensive Care, RWTH Aachen University
name: Christian Stoppe, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bestehorn K. [Medical registries]. Med Klin (Munich). 2005 Nov 15;100(11):722-8. doi: 10.1007/s00063-005-1098-x. German.
citation: Schott G, Berthold HK. Pharmakovigilanz: Empfehlungen zur Meldung unerwünschter Arzneimittelwirkungen durch die Ärzteschaft. Arzneiverordnung in der Praxis. 2005.