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

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care in General
• Intervention / Treatment: Other: Biological Database

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 Type: Observational
• Enrollment (Anticipated): 99999999

Contacts and Locations

• Study Contact: Name: Christina Kalvelage, M. Sc.; Phone Number: 0241 80 36485; Email: ckalvelage@ukaachen.de
• Study Contact Backup: Name: Christian Stoppe, Dr. med.; Phone Number: 0241 80 36575; Email: cstoppe@ukaachen.de

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • Uniklinik RWTH Aachen
    • Contact: Christian Stoppe, PD Dr. med.; Email: cstoppe@ukaachen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

intensive care patients in general

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin 6 value [nmol/l]	Record of clinically relevant parameters	10 days
Interleukin 10 [nmol/l]	Record of clinically relevant parameters	10 days
Adrenomedullin value [nmol/l]	Record of clinically relevant parameters	10 days
Tumornekrosefaktor alpha [nmol/l]	Record of clinically relevant parameters	10 days
Procalcitonin [nmol/l]	Record of clinically relevant parameters	10 days

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Christian Stoppe, Dr. med., Operative Medicine and Intensive Care, RWTH Aachen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): February 1, 2050
• Study Completion (Anticipated): February 1, 2050

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimate): January 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 16-151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided