Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 10:15 PM
Study NCT ID:
NCT01341561
Status:
UNKNOWN
Last Update Posted:
2011-04-25
First Post:
2011-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relevance of Biomarkers in the Process of Weaning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'routine blood parameters'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-22', 'studyFirstSubmitDate': '2011-04-13', 'studyFirstSubmitQcDate': '2011-04-22', 'lastUpdatePostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success of weaning', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 30days', 'description': 'primary outcome measure is the success of weaning during hospital stay. Duration of hospital stay is estimated between 1-60days, in average 30days. Criteria is spontaneous breathing.'}], 'secondaryOutcomes': [{'measure': 'follow up', 'timeFrame': '12 months', 'description': 'Follow up is done after 12 months to check major adverse cardiac or pulmonary events (death, myocardial infarction, re-hospitalisation)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Duration of Weaning']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the relevance of biochemical markers (specific pulmonary and cardiac markers and markers of endogenous stress) in the process of weaning in patients with artificial ventilation.', 'detailedDescription': 'Artificially ventilated patients on our intensive care unit will be monitored if specific biomarkers have a relevance in risk stratification, optimizing therapy, outcome and success in the process of weaning. Therefore, consecutively, specific blood parameters will be taken at time of intubation,day 1 of weaning and extubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'consecutively all patients on our intensive care unit who are artificially ventilated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Able and willing to understand the protocol\n* At least 18 years or older\n\nExclusion Criteria:\n\n* Not fulfilling inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01341561', 'briefTitle': 'Relevance of Biomarkers in the Process of Weaning', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'The Relevance of Biochemical Markers in the Process of Weaning', 'orgStudyIdInfo': {'id': 'TnT hs 4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'weaning patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Evangelos Giannitsis, Prof. Dr.', 'role': 'CONTACT', 'email': 'Evangelos_Giannitsis@med.uni-heidelberg.de', 'phone': '004962215638686'}], 'facility': 'Intensive Care Unit, University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Evangelos Giannitsis, Prof. Dr.', 'role': 'CONTACT', 'email': 'Evangelos_Giannitsis@med.uni-heidelberg.de', 'phone': '0049-6221-56-38686'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Evangelos Giannitsis', 'oldOrganization': 'Department of Cardiology, University of Heidelberg'}}}}