Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-28 @ 12:00 AM
Study NCT ID:
NCT01332734
Status:
COMPLETED
Last Update Posted:
2011-04-11
First Post:
2011-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microcirculatory Changes During Magnesium Sulphate Infusion in Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-04', 'studyFirstSubmitDate': '2011-04-04', 'studyFirstSubmitQcDate': '2011-04-04', 'lastUpdatePostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'microvascular flow index', 'timeFrame': '1 hour', 'description': 'Directly prior to and after 1 hour of magnesium sulphate (MgS) infusion (2 gram) systemic hemodynamic variables, sublingual SDF images and standard laboratory tests, were obtained.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['microcirculation', 'SDF', 'magnesium sulfate'], 'conditions': ['Severe Sepsis', 'Septic Shock']}, 'descriptionModule': {'briefSummary': 'During infections (sepsis) bloodflow in small vessels (microcirculation) becomes disturbed. Restoration of bloodpressure and cardiac performance may not be sufficient to correct these alterations. Magnesium is a potent vasodilator which may be used to open up the small vessels, in order to reduce organ failure.', 'detailedDescription': 'In a single-center open label study we evaluated the effects of magnesium sulphate (MgS) infusion on the sublingual microcirculation perfusion in fluid resuscitated patients with severe sepsis and septic shock within the first 48 hours after ICU admission. Directly prior to and after 1 hour of magnesium sulphate (MgS) infusion (2 gram) systemic hemodynamic variables, sublingual SDF images and standard laboratory tests, were obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'severe sepsis and septic shock after adequate fluid resuscitation according to pulmonary artery catheter measurements', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe sepsis and septic shock\n\nExclusion Criteria:\n\n* pregnancy\n* oral bleeding\n* age \\< 18 years\n* liver cirrhosis\n* acute arrhythmias\n* advanced malignancy or a mean arterial pressure (MAP) \\< 65 mmHg refractory to vasopressors'}, 'identificationModule': {'nctId': 'NCT01332734', 'briefTitle': 'Microcirculatory Changes During Magnesium Sulphate Infusion in Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Frisius Medisch Centrum'}, 'officialTitle': 'Microcirculatory Changes During Open Label Magnesium Sulphate Infusion in Severe Sepsis and Septic Shock', 'orgStudyIdInfo': {'id': '2010-03.03 nr BE-2-6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'severe sepsis and septic shock', 'interventionNames': ['Drug: Magnesium Sulfate']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'description': '2 gram in 1 hour', 'armGroupLabels': ['severe sepsis and septic shock']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LT 44307', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Hospital of Lithuanian university of health sciences', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}], 'overallOfficials': [{'name': 'A Pranskunas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lithuanian university of sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frisius Medisch Centrum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lithuanian University of Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Andrius Pranskunas', 'oldOrganization': 'Lithuanian University of Health Sciences'}}}}