Development of a Biological Database in the Field of Operative Intensive Care

Intensive Care in General Clinical Trial

— Biobank OIM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03014427
• Other study ID #: 16-151
• Status: Recruiting
• Start date: March 1, 2017
• Est. completion date: February 2050

Study information

• Verified date: September 2019
• Source: RWTH Aachen University
• Contact: Christina Kalvelage, M. Sc.
• Phone: 0241 80 36485
• Email: ckalvelage[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99999999
• Est. completion date: February 2050
• Est. primary completion date: February 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intensive Care in General

Intervention

Other:
• Biological Database
Biological Database

Locations

Country	Name	City	State
Germany	Uniklinik RWTH Aachen	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Bestehorn K. [Medical registries]. Med Klin (Munich). 2005 Nov 15;100(11):722-8. Review. German. — View Citation

Schott G, Berthold HK. Pharmakovigilanz: Empfehlungen zur Meldung unerwünschter Arzneimittelwirkungen durch die Ärzteschaft. Arzneiverordnung in der Praxis. 2005.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin 6 value [nmol/l]	Record of clinically relevant parameters	10 days
Primary	Interleukin 10 [nmol/l]	Record of clinically relevant parameters	10 days
Primary	Adrenomedullin value [nmol/l]	Record of clinically relevant parameters	10 days
Primary	Tumornekrosefaktor alpha [nmol/l]	Record of clinically relevant parameters	10 days
Primary	Procalcitonin [nmol/l]	Record of clinically relevant parameters	10 days