Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-31 @ 11:23 AM
Study NCT ID:
NCT00814112
Status:
WITHDRAWN
Last Update Posted:
2024-03-15
First Post:
2008-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycosaminoglycans During Septic Shock - a Temporal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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_WITHOUT_DNA', 'description': 'Plasma and Urine.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of personell', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2008-12-22', 'studyFirstSubmitQcDate': '2008-12-22', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'We have previously shown that the plasma level of glycosaminoglycans (GAG) in septic shock patients are elevated compared to controls. The purpose of this study is to investigate the temporal dynamic of the blood level of GAG in ten septic shock patients. In addition, to assess the kinetics of GAG during septic shock we examine the liver function by galactose elimination capacity as well as excreted urinary GAG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Septic Shock', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2 out of 4 SIRS criteria, where the circulatory criteria must be fulfilled\n* Clinical sepsis is suspected\n* Informed consent from relative\n* Study subject must be over 18 years old\n\nExclusion Criteria:\n\n* Pregnancy\n* \\>24h post sepsis diagnosis\n* Ongoing oral or intravenous cortisone treatment for more than one month.\n* Malignancy with metastasis'}, 'identificationModule': {'nctId': 'NCT00814112', 'acronym': 'GAGS', 'briefTitle': 'Glycosaminoglycans During Septic Shock - a Temporal Study', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'GAGS - Glykosaminoglykaner Vid Sepsis', 'orgStudyIdInfo': {'id': 'GAGS 293/2008'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 septic shock', 'description': 'septic shock, ICU'}, {'label': '2 controls', 'description': 'matched controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Intensive Care Unit, Lund University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Mikael Bodelsson, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intensive Care Unit, Lund University Hospital, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}