Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-08 @ 11:21 PM
Study NCT ID:
NCT03014427
Status:
RECRUITING
Last Update Posted:
2019-09-18
First Post:
2017-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Biological Database in the Field of Operative Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Patients can give consent to the analysis of DNA seperately.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99999999}, 'targetDuration': '10 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2050-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2017-01-06', 'studyFirstSubmitQcDate': '2017-01-06', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2050-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin 6 value [nmol/l]', 'timeFrame': '10 days', 'description': 'Record of clinically relevant parameters'}, {'measure': 'Interleukin 10 [nmol/l]', 'timeFrame': '10 days', 'description': 'Record of clinically relevant parameters'}, {'measure': 'Adrenomedullin value [nmol/l]', 'timeFrame': '10 days', 'description': 'Record of clinically relevant parameters'}, {'measure': 'Tumornekrosefaktor alpha [nmol/l]', 'timeFrame': '10 days', 'description': 'Record of clinically relevant parameters'}, {'measure': 'Procalcitonin [nmol/l]', 'timeFrame': '10 days', 'description': 'Record of clinically relevant parameters'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intensive Care in General']}, 'referencesModule': {'references': [{'pmid': '16328180', 'type': 'BACKGROUND', 'citation': 'Bestehorn K. [Medical registries]. Med Klin (Munich). 2005 Nov 15;100(11):722-8. doi: 10.1007/s00063-005-1098-x. German.'}, {'type': 'BACKGROUND', 'citation': 'Schott G, Berthold HK. Pharmakovigilanz: Empfehlungen zur Meldung unerwünschter Arzneimittelwirkungen durch die Ärzteschaft. Arzneiverordnung in der Praxis. 2005.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSample volumes are defined as follows:\n\n* 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)\n* 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'intensive care patients in general', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients after admission to the intensive care unit\n* 18 years or older\n* signed informed consent\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT03014427', 'acronym': 'Biobank OIM', 'briefTitle': 'Development of a Biological Database in the Field of Operative Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Development of a Biological Database in the Field of Operative Intensive Care for the Recording of Clinically Relevant Parameters of Critically Ill Intensive Patients', 'orgStudyIdInfo': {'id': '16-151'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biological Database', 'type': 'OTHER', 'description': 'Biological Database'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Stoppe, PD Dr. med.', 'role': 'CONTACT', 'email': 'cstoppe@ukaachen.de'}], 'facility': 'Uniklinik RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'centralContacts': [{'name': 'Christina Kalvelage, M. Sc.', 'role': 'CONTACT', 'email': 'ckalvelage@ukaachen.de', 'phone': '0241 80 36485'}, {'name': 'Christian Stoppe, Dr. med.', 'role': 'CONTACT', 'email': 'cstoppe@ukaachen.de', 'phone': '0241 80 36575'}], 'overallOfficials': [{'name': 'Christian Stoppe, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Operative Medicine and Intensive Care, RWTH Aachen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}