Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT00484133
Status:
UNKNOWN
Last Update Posted:
2008-01-22
First Post:
2007-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004298', 'term': 'Dopamine'}, {'id': 'D004280', 'term': 'Dobutamine'}, {'id': 'D017335', 'term': 'Enoximone'}, {'id': 'D005996', 'term': 'Nitroglycerin'}, {'id': 'D009638', 'term': 'Norepinephrine'}], 'ancestors': [{'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'lastUpdateSubmitDate': '2008-01-17', 'studyFirstSubmitDate': '2007-06-06', 'studyFirstSubmitQcDate': '2007-06-06', 'lastUpdatePostDateStruct': {'date': '2008-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Severity, decrease and duration of organ failure over the complete ICU stay', 'timeFrame': 'complete icu stay'}, {'measure': 'Duration of organ support', 'timeFrame': 'during ICU treatment'}, {'measure': 'ICU and hospital length of stay', 'timeFrame': 'hospital stay'}, {'measure': 'ICU and hospital mortality', 'timeFrame': 'hospital stay'}, {'measure': 'Inflammatory response measured by IL-6/IL-10', 'timeFrame': '72 hours'}, {'measure': 'Plasma concentration of asymmetric dimethyl arginine (ADMA', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sepsis', 'severe sepsis', 'microcirculation', 'Orthogonal polarisation spectral'], 'conditions': ['Severe Sepsis', 'Microcirculation']}, 'referencesModule': {'references': [{'pmid': '25032942', 'type': 'DERIVED', 'citation': 'van der Voort PH, van Zanten M, Bosman RJ, van Stijn I, Wester JP, van Raalte R, Oudemans-van Straaten HM, Zandstra DF. Testing a conceptual model on early opening of the microcirculation in severe sepsis and septic shock: a randomised controlled pilot study. Eur J Anaesthesiol. 2015 Mar;32(3):189-98. doi: 10.1097/EJA.0000000000000126.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to asses the recovery of organ failure between two resuscitation protocols in severe sepsis: standard, pressure guided therapy versus a microcirculation guided therapy', 'detailedDescription': 'Despite continued improvements in medical therapy, mortality from septic shock has remained between 30% and 70% for the past three decades with only a slight decrease in mortality rate. Standard treatment of septic shock is fluid resuscitation, followed by agents with vasopressor activity to correct hypotension in septic shock. The question rises whether vasopressors should be the first line of action in septic shock Opening and recruiting the microcirculation are expected to improve regional organ function and tissue distress in severe sepsis. Beside fluid resuscitation, vasodilatation, in this respect, enhances microcirculatory flow while vasoconstriction causes a reduction in microcirculatory flow. On the other hand, a minimal perfusion pressure should be present. Our aim is to asses the effects of two resuscitation protocols in severe sepsis: the "standard treatment" using predefined pressure goals versus a microcirculation guided therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older\n* admission to the intensive care unit with severe sepsis, defined in according with a modification of the American College of Chest Physician/SCCM guidelines criteria\n* intention to provide full intensive care treatment for at least 72 hours and\n* written informed consent to be obtained from patient or next of kin.\n\nExclusion Criteria:\n\n* haematologic malignancy\n* metastatic malignancy\n* AIDS with CD4 \\< 50 cells/mm3\n* liver cirrhosis Child Pugh B \\& C\n* pregnancy\n* post resuscitation with GCS \\< 8 of 15 and treatment with induced hypothermia'}, 'identificationModule': {'nctId': 'NCT00484133', 'briefTitle': 'Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Onze Lieve Vrouwe Gasthuis'}, 'orgStudyIdInfo': {'id': 'WO-06.068'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dopamine', 'type': 'DRUG'}, {'name': 'dobutamine', 'type': 'DRUG'}, {'name': 'enoximone', 'type': 'DRUG'}, {'name': 'nitroglycerine', 'type': 'DRUG'}, {'name': 'noradrenaline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090 HM', 'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rutger v Raalte, MD', 'role': 'CONTACT', 'email': 'R.vanRaalte@olvg.nl', 'phone': '0031205993007'}, {'name': 'Rutger v Raalte, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Onze Lieve Vrouwe Gasthuis, intensive care', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Rutger v Raalte, MD', 'role': 'CONTACT', 'email': 'R.vanRaalte@olvg.nl', 'phone': '0031205993007'}, {'name': 'Peter vd Voort, MD', 'role': 'CONTACT', 'email': 'P.H.J.vanderVoort@olvg.nl', 'phone': '0031205993007'}], 'overallOfficials': [{'name': 'Rutger v Raalte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Onze Lieve Vrouwe Gasthuis, intensive care unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Onze Lieve Vrouwe Gasthuis', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'R. van Raalte', 'oldOrganization': 'Onze Lieve Vrouwe gasthuis'}}}}