Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-31 @ 9:06 PM
Study NCT ID:
NCT05054556
Status:
UNKNOWN
Last Update Posted:
2023-09-26
First Post:
2021-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Galectin and Respiratory Weaning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To correlate the serum levels of galectin-3 and duration of respiratory weaning.', 'timeFrame': '2-3 months', 'description': 'Labaratory test+Clinical data.'}], 'secondaryOutcomes': [{'measure': 'Serum levels of galectin-3 on admission, after weaning and discharge from hospital. Correlation of: galectin-3 and duration of respiratory weaning invasiveness of ventilation parameters and galectin-3 serum levels of galectin-3, proGRP and CA 15-3.', 'timeFrame': '2-3 months', 'description': 'Clinical data, labaratory tests.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Galectin-3 During Respiratory Weaning']}, 'descriptionModule': {'briefSummary': 'Galectin-3 is a biomarker for fibrotic activity. In the course of invasive ventilation, fibrotic changes in the lungs may occur. The study aims to investigate whether the level of galectin-3 levels correlates with clinical weaning parameters.', 'detailedDescription': 'Galectin-3 (Gal-3) is a protein with an important role in cell-cell adhesion, cell-matrix interactions, macrophage activation, angiogenesis, metastasis and apoptosis. Galectin-3 is expressed in the nucleus, cytoplasm, mitochondrion, cell surface, and extracellular space.It is involved in different biological processes: cell adhesion, cell activation and chemoattraction, cell growth and differentiation, cell cycle, and apoptosis. Several studies revealed the function of galectin-3 in cancer, inflammation and (lung) fibrosis, heart disease, and stroke. Expression of galectin-3 is associated with heart failure, including myofibroblast proliferation, fibrogenesis, tissue repair, inflammation, and ventricular remodeling. A correlation between galectin-3 expression levels and various types of fibrosis has been found. Galectin-3 is upregulated in idiopathic pulmonary fibrosis.\n\nMechanical ventilation can cause lung damage, or worsen it if already present. This phenomenon is called ventilation-induced lung damage. Main mechanisms are high tidal volumes causing overexpansion of the lungs (volutrauma), high airway pressure (barotrauma) and cyclical collapse and reopening of atelectatic alveolar regions (atelectrauma) leading to a pulmonary inflammatory reaction called "bio-trauma".\n\nTo evaluate the (potential) lung injury serum levels of galectin-3 are measured on admission to our hospital. During respiratory weaning invasiveness of ventilation will be reduced. Data relating biomarkers especially galectin3 during/after successful respiratory weaning are missing.\n\nThis is why follow up measurements of galectin-3 will be done and correlated with ventilation parameters/duration/ success of respiratory weaning.\n\nPrior studies evaluated the role of proGRP and CA 15-3 in patients with lung fibrosis. As a part of the study galectin-3 serum levels will be correlated with serum levels of proGRP and CA 15-3.\n\nIn summary the aim of this study is to evaluate the diagnostic value of galectin-3 in respiratory weaning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with mechanical ventilation who are admitted to our hospital for respiratory weaning.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* mechanical ventilation\n\nExclusion Criteria:\n\n* history of pulmonary disease\n* left ventricular ejection fraction\\<45%\n* missing declaration of consent'}, 'identificationModule': {'nctId': 'NCT05054556', 'acronym': 'Gal-3', 'briefTitle': 'Galectin and Respiratory Weaning', 'organization': {'class': 'OTHER', 'fullName': 'Asklepios Neurological Clinic Bad Salzhausen'}, 'officialTitle': 'Prognostic Value of Galectin-3 for Success of Respiratory Weaning', 'orgStudyIdInfo': {'id': 'Galectin14092021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Labaratory tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'Estimation of serum levels of the following parameters:\n\ngalectin-3, proBNP, TNI, proGRP, CA15-3, CK, creatinine, urea, crp, pct, leucozytes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64732', 'city': 'Bad König', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Hartwich, MD', 'role': 'CONTACT', 'phone': '+49 60 63 5010'}], 'facility': 'Asklepios Schlossberg Klinik Bad König', 'geoPoint': {'lat': 49.7432, 'lon': 9.0075}}, {'zip': '63667', 'city': 'Nidda', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dirk Bandorski, MD, PhD', 'role': 'CONTACT', 'email': 'd.bandorski@asklepios.com', 'phone': '+496043804212'}, {'name': 'Jens Allendörfer, MD', 'role': 'CONTACT'}], 'facility': 'Neurologische Klinik Bad Salzhausen', 'geoPoint': {'lat': 50.4133, 'lon': 9.00638}}], 'centralContacts': [{'name': 'Dirk Bandorski, MD', 'role': 'CONTACT', 'email': 'd.bandorski@asklepios.com', 'phone': '+496043804212'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asklepios Neurological Clinic Bad Salzhausen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asklepios Schlossberg Clinic Bad Koenig', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}