Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-27 @ 8:54 PM
Study NCT ID:
NCT02885168
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2016-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591161', 'term': '3K3A-APC protein'}, {'id': 'C421124', 'term': 'drotrecogin alfa activated'}, {'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}, {'id': 'D010656', 'term': 'Phenylephrine'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-26', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular reactivity measured with dose-response to phenylephrine', 'timeFrame': 'baseline'}, {'measure': 'Vascular reactivity measured with dose-response to phenylephrine', 'timeFrame': '4 hours'}, {'measure': 'Vascular reactivity measured with dose-response to phenylephrine', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vasoreactivity', 'recombinant activated protein C'], 'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein C (APC).\n\nThis amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ROS) markers and increase of circulating catecholamines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with septic shock as determined by standard criteria (including infection and severe infection)\n\nExclusion Criteria:\n\n* Pregnant women\n* Absence of signed informed consent. Due to gravity of medical situation of patients, inclusion will be possible after informed consent of a family member. As soon as possible, an informed consent will be obtained by patient\n* Contraindication to Xigris: evolutive internal bleeding , intracranial pathology, neoplasia or brain involvement, concomitant heparin therapy \\>= 15 IU/kg/h, known hemorrhagic diathesis except acute coagulopathy subsequent to sepsis, severe chronic liver disease, platelet count \\< 30000 x 10\\^6/L, high bleeding risk, known hypersensibility to drotrecogin alfa (activated), one of excipients or bovine thrombin'}, 'identificationModule': {'nctId': 'NCT02885168', 'acronym': 'PCA', 'briefTitle': 'Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C', 'orgStudyIdInfo': {'id': '2007-002319-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shock + Treatment', 'description': 'Patients treated with activated protein C', 'interventionNames': ['Drug: Recombinant Activated Protein C', 'Device: Near-infrared spectroscopy (NIRS)', 'Drug: Phenylephrine', 'Biological: Blood sample']}, {'type': 'OTHER', 'label': 'Shock', 'description': 'Patients not treated with activated protein C', 'interventionNames': ['Device: Near-infrared spectroscopy (NIRS)', 'Drug: Phenylephrine', 'Biological: Blood sample']}], 'interventions': [{'name': 'Recombinant Activated Protein C', 'type': 'DRUG', 'otherNames': ['Xigris'], 'description': '24 μg/kg/h during 96 hours - intravenous injection', 'armGroupLabels': ['Shock + Treatment']}, {'name': 'Near-infrared spectroscopy (NIRS)', 'type': 'DEVICE', 'description': 'After baseline measurement, cuff is blown up to obtain a muscular saturation at 40% and then deflated. Reactive hyperthermia is measured. It is considered as an index for endothelial function.', 'armGroupLabels': ['Shock', 'Shock + Treatment']}, {'name': 'Phenylephrine', 'type': 'DRUG', 'description': 'Continuous administration of phenylephrine with electric syringe with increasing dosing levels: 0.0; 0.02; 0.05; 0.1; 0.2; 0.5; 0.75; 1.00; 1.50; 3.00; 4.50; 6.00; 9.00 et 12 µg/kg/min. Each level is maintained for 5 minutes. Administration of phenylephrine is stopped progressively with the same schema.\n\nArterial tension through an invasive approach is measured during the test.', 'armGroupLabels': ['Shock', 'Shock + Treatment']}, {'name': 'Blood sample', 'type': 'BIOLOGICAL', 'description': 'Analysis of inflammation and cellular adhesion markers and free radicals', 'armGroupLabels': ['Shock', 'Shock + Treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bruno LEVY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Réanimation Médicale - Hôpital de Brabois - CHRU Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}