Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-25 @ 7:20 AM
Study NCT ID:
NCT02237833
Status:
TERMINATED
Last Update Posted:
2017-04-27
First Post:
2014-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious 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': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Too slow recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2014-09-08', 'studyFirstSubmitQcDate': '2014-09-09', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours', 'timeFrame': '24 hours', 'description': 'SCO2 will be measured before initiating vasopressor therapy. Thereafter SCO2 are updated every 2 seconds and is measured for 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Incidence of acute myocardial infarction', 'timeFrame': 'Hospital discharge, expected 12 days at average', 'description': 'Incidence of acute myocardial infarction based on international criteria'}, {'measure': 'Use of vasopressors/inotropes', 'timeFrame': 'Discharge from ICU, expected 5 days at average', 'description': 'Use of vasopressors/inotropes\n\n* norepinephrine\n* epinephrine\n* dopamine\n* dobutamine\n* vasopressin\n* nitroprusside\n* glyceryltrinitrate'}, {'measure': 'Fluid balance', 'timeFrame': '24 hours'}, {'measure': 'Length of stay in ICU', 'timeFrame': 'Discharge from ICU, expected 5 days at average'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'Discharge from hospital, expected 10 days at average'}, {'measure': 'Incidence of organ failure', 'timeFrame': 'Discharge from ICU, expected 5 days at average', 'description': 'Measuring Sequential Organ Failure Assessment, SOFA, score at inclusion and once daily during ICU-stay.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['septic shock', 'cerebral oximetry', 'vasopressor', 'norepinephrine'], 'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to reveal if higher doses of vasopressors in septic shock patients correlates with cerebral vasoconstriction and lower cerebral oximetry.', 'detailedDescription': 'The mortality with septic shock is high. Treatment includes antibiotics, intravenous fluid and drugs for circulatory support, especially the vasopressor norepinephrine. Fluids and drugs for circulatory support are to restore adequate organ perfusion. Inadequate oxygenation of the brain can give neurologic damage. Traditionally treatment is guided by surrogate markers like arterial and central venous pressure. Cerebral oximetry is a non-invasive method which measures cerebral saturation of oxygen, SCO2, and thereby expresses regional cerebral perfusion. By registering cerebral oxymetry on patients treated with vasopressors for septic shock we want to reveal if higher doses of vasopressor correlates with cerebral vasoconstriction and lower cerebral oximetry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the intensive care unit needing vasopressor for septic shock.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Septic shock patients in ICU department requiring vasopressor therapy\n\nExclusion Criteria:\n\n* Damage to the frontal lobes corresponding to the area where SCO2 is monitored\n* Patients in pharmacological studies\n* Patients with known intracranial vascular anomalies or cerebral aneurysms\n* Patients where vasoactive medication is started before cerebral oxymetry is established\n* Patients with known neurological disease\n* Patients with undergone cerebral insult, transient ischemic attack or carotid stenosis\n* Patients who have been resuscitated after cardiac arrest in connection with this hospital stay\n* Patients with a body temperature below 35 degrees Celsius when establishing monitoring'}, 'identificationModule': {'nctId': 'NCT02237833', 'acronym': 'CONSCIOUS', 'briefTitle': 'Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study', 'organization': {'class': 'OTHER', 'fullName': 'Sykehuset i Vestfold HF'}, 'officialTitle': 'Cerebral Oxygenation in Septic Patients Using Vasopressors - The Conscious Study', 'orgStudyIdInfo': {'id': '2014/194 REK'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Septic shock and vasopressor', 'description': 'Measuring cerebral oxymetry (SCO2) first 24 hours in septic shock and given vasopressors.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-3117', 'city': 'Tønsberg', 'state': 'Vestfold', 'country': 'Norway', 'facility': 'Sykehuset i Vestfold HF', 'geoPoint': {'lat': 59.26754, 'lon': 10.40762}}], 'overallOfficials': [{'name': 'Karl-Andre Wian, cand.med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Syekhuset Vestfold HF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karl-Andre Wian', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Karl-Andre Wian', 'investigatorAffiliation': 'Sykehuset i Vestfold HF'}}}}