<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03014427</url>
  </required_header>
  <id_info>
    <org_study_id>16-151</org_study_id>
    <nct_id>NCT03014427</nct_id>
  </id_info>
  <brief_title>Development of a Biological Database in the Field of Operative Intensive Care</brief_title>
  <acronym>Biobank OIM</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RWTH Aachen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RWTH Aachen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The storage and use of biomaterial samples is an important requirement for accompanying&#xD;
      research and the acquisition of new knowledge to improve prognosis and therapy. Biobanking is&#xD;
      explicitly recommended in official guidelines. In order to preserve the biomaterial, the&#xD;
      patient must consent to the removal, transfer and storage of the biomaterial separately from&#xD;
      the consent to the register. The biomaterial is taken at times at which a blood or urine&#xD;
      sampling takes place anyway in the clinical routine. Therefore no additional interventions&#xD;
      are necessary.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The storage and use of biomaterial samples is an important requirement for accompanying&#xD;
      research and the acquisition of new knowledge to improve prognosis and therapy. Biobanking is&#xD;
      explicitly recommended in official guidelines. In order to preserve the biomaterial, the&#xD;
      patient must consent to the removal, transfer and storage of the biomaterial separately from&#xD;
      the consent to the register. The biomaterial is taken at times at which a blood or urine&#xD;
      sampling takes place anyway in the clinical routine. Therefore no additional interventions&#xD;
      are necessary.&#xD;
&#xD;
      Sample volumes are defined as follows:&#xD;
&#xD;
        -  Peripheral blood: up to a total of 150 ml distributed to a maximum of 10 morning blood&#xD;
           samples (approximately 15 ml blood per blood sample) during the inpatient stay in the&#xD;
           intensive care unit (fixed times are admission and discharge of the intensive care unit)&#xD;
&#xD;
        -  Urine: a total of up to 200 ml of catheter urine distributed to a maximum of 10 morning&#xD;
           withdrawals during inpatient stays in the intensive care unit (defined times are&#xD;
           admission and discharge from the intensive care unit)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">February 2050</completion_date>
  <primary_completion_date type="Anticipated">February 2050</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Days</target_duration>
  <primary_outcome>
    <measure>Interleukin 6 value [nmol/l]</measure>
    <time_frame>10 days</time_frame>
    <description>Record of clinically relevant parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin 10 [nmol/l]</measure>
    <time_frame>10 days</time_frame>
    <description>Record of clinically relevant parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adrenomedullin value [nmol/l]</measure>
    <time_frame>10 days</time_frame>
    <description>Record of clinically relevant parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumornekrosefaktor alpha [nmol/l]</measure>
    <time_frame>10 days</time_frame>
    <description>Record of clinically relevant parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procalcitonin [nmol/l]</measure>
    <time_frame>10 days</time_frame>
    <description>Record of clinically relevant parameters</description>
  </primary_outcome>
  <enrollment type="Anticipated">99999999</enrollment>
  <condition>Intensive Care in General</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biological Database</intervention_name>
    <description>Biological Database</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Patients can give consent to the analysis of DNA seperately.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        intensive care patients in general&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients after admission to the intensive care unit&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria are formulated with regard to the objective of the register to&#xD;
             record intensive care patients in general. Patients with multiple comorbidities, organ&#xD;
             dysfunctions, and non-compliance for a curatively-intended therapy should also be&#xD;
             recorded in the register. A palliative treatment or decision for best supportive care&#xD;
             is not an exclusion criterion for registering.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Stoppe, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Operative Medicine and Intensive Care, RWTH Aachen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christina Kalvelage, M. Sc.</last_name>
    <phone>0241 80 36485</phone>
    <email>ckalvelage@ukaachen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christian Stoppe, Dr. med.</last_name>
    <phone>0241 80 36575</phone>
    <email>cstoppe@ukaachen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Uniklinik RWTH Aachen</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Stoppe, PD Dr. med.</last_name>
      <email>cstoppe@ukaachen.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Bestehorn K. [Medical registries]. Med Klin (Munich). 2005 Nov 15;100(11):722-8. doi: 10.1007/s00063-005-1098-x. German.</citation>
    <PMID>16328180</PMID>
  </reference>
  <reference>
    <citation>Schott G, Berthold HK. Pharmakovigilanz: Empfehlungen zur Meldung unerwünschter Arzneimittelwirkungen durch die Ärzteschaft. Arzneiverordnung in der Praxis. 2005.</citation>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03014427
org study id: 16-151
nct id: NCT03014427
lead sponsor: 
has dmc: No
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.
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)
observational model: Other
time perspective: Prospective
measure: Interleukin 6 value [nmol/l]
time frame: 10 days
description: Record of clinically relevant parameters
measure: Interleukin 10 [nmol/l]
time frame: 10 days
description: Record of clinically relevant parameters
measure: Adrenomedullin value [nmol/l]
time frame: 10 days
description: Record of clinically relevant parameters
measure: Tumornekrosefaktor alpha [nmol/l]
time frame: 10 days
description: Record of clinically relevant parameters
measure: Procalcitonin [nmol/l]
time frame: 10 days
description: Record of clinically relevant parameters
intervention type: Other
intervention name: Biological Database
description: Biological Database
Patients can give consent to the analysis of DNA seperately.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Stoppe, Dr. med.
role: Principal Investigator
affiliation: Operative Medicine and Intensive Care, RWTH Aachen University
last name: Christina Kalvelage, M. Sc.
phone: 0241 80 36485
email: ckalvelage@ukaachen.de
last name: Christian Stoppe, Dr. med.
phone: 0241 80 36575
email: cstoppe@ukaachen.de
facility: 
status: Recruiting
contact: 
country: Germany
citation: Bestehorn K. [Medical registries]. Med Klin (Munich). 2005 Nov 15;100(11):722-8. doi: 10.1007/s00063-005-1098-x. German.
PMID: 16328180
citation: Schott G, Berthold HK. Pharmakovigilanz: Empfehlungen zur Meldung unerwünschter Arzneimittelwirkungen durch die Ärzteschaft. Arzneiverordnung in der Praxis. 2005.
responsible party type: Sponsor
sharing ipd: Undecided