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Development of a Biological Database in the Field of Operative Intensive Care (Biobank OIM)

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ClinicalTrials.gov Identifier: NCT03014427
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease Intervention/treatment
Intensive Care in General 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)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 99999999 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Days
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
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 2050
Estimated Study Completion Date : February 2050

Intervention Details:
  • Other: Biological Database
    Biological Database


Primary Outcome Measures :
  1. Interleukin 6 value [nmol/l] [ Time Frame: 10 days ]
    Record of clinically relevant parameters

  2. Interleukin 10 [nmol/l] [ Time Frame: 10 days ]
    Record of clinically relevant parameters

  3. Adrenomedullin value [nmol/l] [ Time Frame: 10 days ]
    Record of clinically relevant parameters

  4. Tumornekrosefaktor alpha [nmol/l] [ Time Frame: 10 days ]
    Record of clinically relevant parameters

  5. Procalcitonin [nmol/l] [ Time Frame: 10 days ]
    Record of clinically relevant parameters


Biospecimen Retention:   Samples With DNA
Patients can give consent to the analysis of DNA seperately.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
intensive care patients in general
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014427


Contacts
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Contact: Christina Kalvelage, M. Sc. 0241 80 36485 ckalvelage@ukaachen.de
Contact: Christian Stoppe, Dr. med. 0241 80 36575 cstoppe@ukaachen.de

Locations
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Germany
Uniklinik RWTH Aachen Recruiting
Aachen, Germany, 52074
Contact: Christian Stoppe, PD Dr. med.       cstoppe@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Christian Stoppe, Dr. med. Operative Medicine and Intensive Care, RWTH Aachen University
Additional Information:

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

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03014427    
Other Study ID Numbers: 16-151
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided