Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-21 @ 11:19 PM
Study NCT ID:
NCT03060369
Status:
UNKNOWN
Last Update Posted:
2017-02-23
First Post:
2013-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BWH Critical Care Study of CareGuide for Evaluation of Emerging or Established Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2013-08-01', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak systemic lactate', 'timeFrame': 'Duration of monitoring (< 1 week)', 'description': 'Cohort A'}], 'secondaryOutcomes': [{'measure': 'Peak systemic lactate', 'timeFrame': 'Duration of monitoring (< 1 week)', 'description': 'Cohort B'}, {'measure': 'Temporal assessment of SmO2 and lactate', 'timeFrame': 'Duration of monitoring (< 1 week)'}, {'measure': 'Standard hemodynamic measures stratified by shock type (cardiogenic, hypovolemic, distributive)', 'timeFrame': 'Duration of monitoring (< 1 week)'}, {'measure': 'Systemic pH', 'timeFrame': 'Duration of monitoring (< 1 week)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tissue Perfusion', 'Noninvasive Monitoring', 'Near-infrared spectroscopy', 'CareGuide'], 'conditions': ['Shock']}, 'descriptionModule': {'briefSummary': 'This pilot study aims to examine the relationship between continuously measured CareGuide™ muscle oxygen saturation (SmO2), tissue pH and data provided from standard monitoring techniques during the care of subjects with suspected established (Cohort A) or emerging (Cohort B) shock in the intensive care unit (ICU).', 'detailedDescription': 'Approximately 50 subjects meeting recruitment criteria will be enrolled with a minimum of 20 subjects meeting entry criteria for established shock (Cohort A).\n\nNoninvasive near-infrared spectroscopy CareGuide™ measurements of SmO2, tissue pH and hematocrit will be collected from enrollment through device removal. These data will be compared to specific hemodynamic and laboratory parameters obtained as a part of routine care during the CareGuide™ monitoring period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Our study population is made up of adults admitted to an ICU with established or emerging shock.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects who are:\n\n1. To be admitted to the intensive care unit\n2. At least 18 years of age\n3. Men or Women\n4. Informed consent from subject or surrogate\n5. Clinical diagnosis of established (Cohort A) or emerging (Cohort B) shock, as described above.\n\nExclusion Criteria:\n\nSubjects with:\n\n1. Body mass index \\>37\n2. Trauma (primary diagnosis)\n3. Pregnancy\n4. Non-global conditions leading to regional increased lactate production (e.g. isolated thrombotic or embolic phenomena, limb, compartment syndrome)\n5. Known untreated hypothyroidism\n6. Known hypersensitivity to medical adhesives\n7. Suspected carbon monoxide poisoning or methemoglobinemia\n8. Goals of care restricting vital sign acquisition\n9. Family member of investigators or study staff'}, 'identificationModule': {'nctId': 'NCT03060369', 'briefTitle': 'BWH Critical Care Study of CareGuide for Evaluation of Emerging or Established Shock', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'BWH Critical Care Study of CareGuide for Evaluation of Emerging or Established Shock', 'orgStudyIdInfo': {'id': 'BWH CareGuide'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Established Shock (Cohort A)', 'description': 'Meeting criteria i or ii, AND iii:\n\ni. SBP ≤ 90mm Hg for greater than 30 minutes ii. Requirement for vasopressor or ionotrope to maintain SBP \\> 90mm Hg iii. New dysfunction of at least one organ, including altered mental status, acute renal failure (increase from baseline in serum creatinine \\>0.3 mg/dL or by 50%), oliguria (\\<0.5 mL/kg/h for \\>6h) , or hepatic injury (ALT, AST, or total bilirubin \\>2xULN)suspected by the treating physician to be caused by organ hypoperfusion', 'interventionNames': ['Device: CareGuide™ device']}, {'label': 'Emerging Shock (Cohort B)', 'description': 'Meeting criteria i or ii, AND iii:\n\ni. New SBP ≤ 90mm Hg for greater than 30 minutes or recurrent shorter episodes, requiring use of or clinical anticipation of the need for fluid resuscitation or vasopressor/inotropic support to maintain SBP \\> 90 mm Hg ii. New dysfunction of at least one organ (as defined above), including altered mental status, acute renal failure, oliguria, or hepatic injury not explained by a specific non-hemodynamic cause iii. Does not meet criteria for Established Shock', 'interventionNames': ['Device: CareGuide™ device']}], 'interventions': [{'name': 'CareGuide™ device', 'type': 'DEVICE', 'description': 'CareGuide™ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation.', 'armGroupLabels': ['Emerging Shock (Cohort B)', 'Established Shock (Cohort A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Reflectance Medical, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Stephen D. Wiviott', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}