Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-09 @ 12:57 PM
Study NCT ID:
NCT01632059
Status:
COMPLETED
Last Update Posted:
2017-08-03
First Post:
2012-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examination of ADMA Serum Level and DDAH II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2012-03-13', 'studyFirstSubmitQcDate': '2012-06-28', 'lastUpdatePostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADMA serum levels', 'timeFrame': '7 days', 'description': 'measuring of ADMA serum levels on day 1, 3, 7'}], 'secondaryOutcomes': [{'measure': '28 day mortality', 'timeFrame': '28 day'}, {'measure': 'hospitalisation (ICU and peripheral)', 'timeFrame': '28 days'}, {'measure': 'severity of illness', 'timeFrame': '28 days'}, {'measure': 'DDAH Ii polymorphism', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADMA', 'DDAH II', 'SAPS', 'SOFA', 'Sepsis', 'Procalcitonin', 'ICU', 'mortality', 'length of stay'], 'conditions': ['Septic Shock', 'Sepsis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uke.uni-hamburg.de', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Examination of ADMA (Asymmetric-Dimethylarginine)-serum level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in patients with severe Sepsis and septic shock as prognostic value.\n\nThis study looks into ADMA as a good prognostic factor for sepsis. Further more the dependency of the ADMA level to the DDAH II polymorphisms is reviewed this study.', 'detailedDescription': 'Secondary targets are the mortality (28 days ICU), the length of hospitalisation in ICU and peripheral station, the severity of the illness (SAPS II score), the SOFA-score values in the progress and the procalcitonin values in the progress'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients \\> 18 y/o with sepsis and/or septical shock', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 y/o\n* sepsis\n* septical shock\n\nExclusion Criteria:\n\n* primary cardiogenic shock\n* pregnancy\n* breastfeeding\n* non compliance\n* moribund status'}, 'identificationModule': {'nctId': 'NCT01632059', 'acronym': 'ADSeS', 'briefTitle': 'Examination of ADMA Serum Level and DDAH II', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Examination of ADMA (Asymmetric-dimethylarginine)-Serum Level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in Patients With Severe Sepsis and Septic Shock as Prognostic Value', 'orgStudyIdInfo': {'id': 'ADSeS (PV3927)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'septical patients', 'description': 'inclusion criteria are severe sepsis and septical shock and must be \\> 18 y/o'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätskrankenhaus Hamburg Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Stefan Kluge, Priv.-Doz.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director of critical care center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}