Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT02856594
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oluwaseun.akeju@mgh.harvard.edu', 'phone': '617-724-7200', 'title': 'Dr, Oluwaseun Johson-Akeju', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were evaluated until discharge from the hospital. Mortality was assessed until 180 days postoperatively.', 'description': 'Adverse events were collected via review of the electronic medical record or by phone call at 30, 90 or 180 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Dexmedetomidine-induced Sleep', 'description': 'Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.\n\nDexmedetomidine: Dexmedetomidine', 'otherNumAtRisk': 188, 'deathsNumAtRisk': 188, 'otherNumAffected': 0, 'seriousNumAtRisk': 188, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.\n\nPlacebo: Placebo', 'otherNumAtRisk': 206, 'deathsNumAtRisk': 206, 'otherNumAffected': 0, 'seriousNumAtRisk': 206, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine-induced Sleep', 'description': 'Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.\n\nDexmedetomidine: Dexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.83', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post operative day 1 (24 hours)', 'description': 'Confusion Assessment Method', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU Delirium/Coma-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine-induced Sleep', 'description': 'Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.\n\nDexmedetomidine: Dexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.\n\nPlacebo: Placebo'}], 'classes': [{'title': '0 Days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '1 Day', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '2 Days', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '3 Days', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5', 'description': 'Confusion Assessment Method', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine-induced Sleep', 'description': 'Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.\n\nDexmedetomidine: Dexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '5.0'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.03', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5', 'description': 'Confusion Assessment Method (CAM): Minimum Score=0, Maximum Score=19, Higher Scores: indicate increased severity of delirium', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '30-day, 90-day, and 180-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine-induced Sleep', 'description': 'Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.\n\nDexmedetomidine: Dexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.\n\nPlacebo: Placebo'}], 'classes': [{'title': 'In Hospital Mortality', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '30 Days', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '90 Days', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '180 Days', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to postoperative day 180 (6 months)', 'description': '30-day, 90-day, and 180-day mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Cognitive Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine-induced Sleep', 'description': 'Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.\n\nDexmedetomidine: Dexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.\n\nPlacebo: Placebo'}], 'classes': [{'title': '30 Days', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '21.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '21.0'}]}]}, {'title': '90 Days', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '21.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '21.0'}]}]}, {'title': '180 Days', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '21.0'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '22.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days, 90 days, and 180 days postoperatively', 'description': 'Telephone Montreal Cognitive Assessment (tMoCA): Minimum Score=0, Maximum Score=22, Higher Scores: indicate better cognitive function', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Health Related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine-induced Sleep', 'description': 'Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.\n\nDexmedetomidine: Dexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.\n\nPlacebo: Placebo'}], 'classes': [{'title': 'PROMIS Global Health - Physical (30 Days)', 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000', 'lowerLimit': '44.9', 'upperLimit': '54.1'}, {'value': '47.7', 'groupId': 'OG001', 'lowerLimit': '42.3', 'upperLimit': '54.1'}]}]}, {'title': 'PROMIS Global Health - Physical (90 Days)', 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000', 'lowerLimit': '47.7', 'upperLimit': '59.8'}, {'value': '54.1', 'groupId': 'OG001', 'lowerLimit': '47.7', 'upperLimit': '57.7'}]}]}, {'title': 'PROMIS Global Health - Physical (180Days)', 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000', 'lowerLimit': '50.8', 'upperLimit': '61.9'}, {'value': '54.1', 'groupId': 'OG001', 'lowerLimit': '50.8', 'upperLimit': '61.9'}]}]}, {'title': 'PROMIS Global Health - Mental (30 Days)', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000', 'lowerLimit': '50.8', 'upperLimit': '67.6'}, {'value': '56.0', 'groupId': 'OG001', 'lowerLimit': '50.8', 'upperLimit': '62.5'}]}]}, {'title': 'PROMIS Global Health - Mental (90 Days)', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000', 'lowerLimit': '53.3', 'upperLimit': '67.6'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '56.0', 'upperLimit': '67.6'}]}]}, {'title': 'PROMIS Global Health - Mental (180 Days)', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '53.3', 'upperLimit': '67.6'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '53.3', 'upperLimit': '67.6'}]}]}, {'title': 'PROMIS Physical Function (30 Days)', 'categories': [{'measurements': [{'value': '49.9', 'groupId': 'OG000', 'lowerLimit': '40.7', 'upperLimit': '55.8'}, {'value': '52.3', 'groupId': 'OG001', 'lowerLimit': '40.7', 'upperLimit': '58.1'}]}]}, {'title': 'PROMIS Physical Function (90 Days)', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000', 'lowerLimit': '40.7', 'upperLimit': '51.2'}, {'value': '40.7', 'groupId': 'OG001', 'lowerLimit': '40.7', 'upperLimit': '49.9'}]}]}, {'title': 'PROMIS Physical Function (180 Days)', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000', 'lowerLimit': '40.7', 'upperLimit': '47.9'}, {'value': '40.7', 'groupId': 'OG001', 'lowerLimit': '40.7', 'upperLimit': '40.7'}]}]}, {'title': 'PROMIS Pain Interference (30 Days)', 'categories': [{'measurements': [{'value': '49.9', 'groupId': 'OG000', 'lowerLimit': '40.7', 'upperLimit': '55.8'}, {'value': '52.3', 'groupId': 'OG001', 'lowerLimit': '40.7', 'upperLimit': '58.1'}]}]}, {'title': 'PROMIS Pain Interference (90 Days)', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000', 'lowerLimit': '40.7', 'upperLimit': '51.2'}, {'value': '40.7', 'groupId': 'OG001', 'lowerLimit': '40.7', 'upperLimit': '49.9'}]}]}, {'title': 'PROMIS Pain Interference (180 Days)', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000', 'lowerLimit': '40.7', 'upperLimit': '47.9'}, {'value': '40.7', 'groupId': 'OG001', 'lowerLimit': '40.7', 'upperLimit': '40.7'}]}]}, {'title': 'PROMIS Applied Cognition (30 Days)', 'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000', 'lowerLimit': '48.6', 'upperLimit': '62.7'}, {'value': '53.0', 'groupId': 'OG001', 'lowerLimit': '47.7', 'upperLimit': '62.7'}]}]}, {'title': 'PROMIS Applied Cognition (90 Days)', 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000', 'lowerLimit': '49.5', 'upperLimit': '62.7'}, {'value': '54.6', 'groupId': 'OG001', 'lowerLimit': '47.7', 'upperLimit': '62.7'}]}]}, {'title': 'PROMIS Applied Cognition (180 Days)', 'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000', 'lowerLimit': '47.7', 'upperLimit': '62.7'}, {'value': '54.6', 'groupId': 'OG001', 'lowerLimit': '48.6', 'upperLimit': '62.7'}]}]}, {'title': 'PROMIS Sleep Disturbance (30 Days)', 'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000', 'lowerLimit': '43.8', 'upperLimit': '56.1'}, {'value': '50.5', 'groupId': 'OG001', 'lowerLimit': '43.8', 'upperLimit': '56.1'}]}]}, {'title': 'PROMIS Sleep Disturbance (90 Days)', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000', 'lowerLimit': '43.8', 'upperLimit': '52.4'}, {'value': '48.4', 'groupId': 'OG001', 'lowerLimit': '41.1', 'upperLimit': '52.4'}]}]}, {'title': 'PROMIS Sleep Disturbance (180 Days)', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '41.1', 'upperLimit': '51.5'}, {'value': '46.2', 'groupId': 'OG001', 'lowerLimit': '41.1', 'upperLimit': '50.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days, 90 days, and 180 days postoperatively', 'description': 'This included the PROMIS Global Health SF V.1.1, PROMIS Physical Function SF 8b V.1.2, PROMIS Pain Interference SF 8a V.1.0, PROMIS Applied Cognition Abilities SF 8a V.1.0, and PROMIS Sleep Disturbance SF 4A V.1.0, respectively. Scores from each assessment were converted to a T-score for analysis with a mean of 50 and a standard deviation of 10, with lower scores on the PROMIS Pain Interference SF and PROMIS Sleep Disturbance SF considered better, whereas higher scores on all other assessments were considered better.', 'unitOfMeasure': 'T-Score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Delirium Biomarkers', 'timeFrame': 'perioperative', 'description': 'Blood samples will be taken including whole blood, serum, TruCulture, and PAXgene to assess proteins, DNA, and RNA.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'EEG Delirium Biomarkers', 'timeFrame': 'intraoperative', 'description': 'EEG burst suppression and alpha power will be analyzed for association with delirium.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexmedetomidine-induced Sleep', 'description': 'Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.\n\nDexmedetomidine: Dexmedetomidine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '8.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from postoperative day 0 until date of hospital discharge (no prespecified length possible)', 'description': 'Medical Record Review', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexmedetomidine-induced Sleep', 'description': 'Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.\n\nDexmedetomidine: Dexmedetomidine'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.\n\nPlacebo: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '235'}]}, {'type': 'Analysis Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '206'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '206'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '29'}]}]}], 'preAssignmentDetails': 'There were no significant events in the study following enrollment but prior to assignment of participants to an arm or group. All enrolled subjects were assigned to either of the two study groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '394', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexmedetomidine-induced Sleep', 'description': 'Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.\n\nDexmedetomidine: Dexmedetomidine'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.\n\nPlacebo: Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'groupId': 'BG000', 'lowerLimit': '63.0', 'upperLimit': '73.0'}, {'value': '70.0', 'groupId': 'BG001', 'lowerLimit': '65.0', 'upperLimit': '75.0'}, {'value': '69.0', 'groupId': 'BG002', 'lowerLimit': '64.0', 'upperLimit': '74.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Delirium Incidence at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preoperative Cognitive Status', 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'groupId': 'BG000', 'lowerLimit': '17.0', 'upperLimit': '20.0'}, {'value': '19.0', 'groupId': 'BG001', 'lowerLimit': '18.0', 'upperLimit': '20.0'}, {'value': '19.0', 'groupId': 'BG002', 'lowerLimit': '17.0', 'upperLimit': '20.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Telephone Montreal Cognitive Assessment', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Preoperative Health Related Quality of Life', 'classes': [{'title': 'Global Health - Physical', 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'BG000', 'lowerLimit': '42.3', 'upperLimit': '57.7'}, {'value': '50.8', 'groupId': 'BG001', 'lowerLimit': '44.9', 'upperLimit': '57.7'}, {'value': '50.8', 'groupId': 'BG002', 'lowerLimit': '42.3', 'upperLimit': '57.7'}]}]}, {'title': 'Global Health - Mental', 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'BG000', 'lowerLimit': '50.8', 'upperLimit': '62.5'}, {'value': '56.0', 'groupId': 'BG001', 'lowerLimit': '48.3', 'upperLimit': '62.5'}, {'value': '56.0', 'groupId': 'BG002', 'lowerLimit': '50.8', 'upperLimit': '62.5'}]}]}, {'title': 'Physical Function', 'categories': [{'measurements': [{'value': '44.6', 'groupId': 'BG000', 'lowerLimit': '38.8', 'upperLimit': '52.5'}, {'value': '46.4', 'groupId': 'BG001', 'lowerLimit': '40.1', 'upperLimit': '52.5'}, {'value': '45.5', 'groupId': 'BG002', 'lowerLimit': '39.58', 'upperLimit': '52.5'}]}]}, {'title': 'Pain Interference', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'BG000', 'lowerLimit': '40.7', 'upperLimit': '55.4'}, {'value': '40.7', 'groupId': 'BG001', 'lowerLimit': '40.7', 'upperLimit': '51.2'}, {'value': '40.7', 'groupId': 'BG002', 'lowerLimit': '40.7', 'upperLimit': '53.2'}]}]}, {'title': 'Applied Cognition', 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'BG000', 'lowerLimit': '45.9', 'upperLimit': '62.7'}, {'value': '51.2', 'groupId': 'BG001', 'lowerLimit': '45.9', 'upperLimit': '62.7'}, {'value': '51.7', 'groupId': 'BG002', 'lowerLimit': '45.9', 'upperLimit': '62.7'}]}]}, {'title': 'Sleep Disturbance', 'categories': [{'measurements': [{'value': '50.5', 'groupId': 'BG000', 'lowerLimit': '43.8', 'upperLimit': '56.1'}, {'value': '50.5', 'groupId': 'BG001', 'lowerLimit': '43.8', 'upperLimit': '54.3'}, {'value': '50.5', 'groupId': 'BG002', 'lowerLimit': '43.8', 'upperLimit': '56.1'}]}]}], 'paramType': 'MEDIAN', 'description': 'PROMIS-29 questionnaires', 'unitOfMeasure': 'Values are reported using a T-Score.', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-15', 'size': 247416, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-13T16:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 469}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2016-07-29', 'resultsFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-21', 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of Hospital Stay', 'timeFrame': 'from postoperative day 0 until date of hospital discharge (no prespecified length possible)', 'description': 'Medical Record Review'}], 'primaryOutcomes': [{'measure': 'Incidence of Delirium', 'timeFrame': 'Post operative day 1 (24 hours)', 'description': 'Confusion Assessment Method'}], 'secondaryOutcomes': [{'measure': 'ICU Delirium/Coma-free Days', 'timeFrame': 'Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5', 'description': 'Confusion Assessment Method'}, {'measure': 'Severity of Delirium', 'timeFrame': 'Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5', 'description': 'Confusion Assessment Method (CAM): Minimum Score=0, Maximum Score=19, Higher Scores: indicate increased severity of delirium'}, {'measure': '30-day, 90-day, and 180-day Mortality', 'timeFrame': 'Up to postoperative day 180 (6 months)', 'description': '30-day, 90-day, and 180-day mortality'}, {'measure': 'Postoperative Cognitive Status', 'timeFrame': '30 days, 90 days, and 180 days postoperatively', 'description': 'Telephone Montreal Cognitive Assessment (tMoCA): Minimum Score=0, Maximum Score=22, Higher Scores: indicate better cognitive function'}, {'measure': 'Postoperative Health Related Quality of Life', 'timeFrame': '30 days, 90 days, and 180 days postoperatively', 'description': 'This included the PROMIS Global Health SF V.1.1, PROMIS Physical Function SF 8b V.1.2, PROMIS Pain Interference SF 8a V.1.0, PROMIS Applied Cognition Abilities SF 8a V.1.0, and PROMIS Sleep Disturbance SF 4A V.1.0, respectively. Scores from each assessment were converted to a T-score for analysis with a mean of 50 and a standard deviation of 10, with lower scores on the PROMIS Pain Interference SF and PROMIS Sleep Disturbance SF considered better, whereas higher scores on all other assessments were considered better.'}, {'measure': 'Blood Delirium Biomarkers', 'timeFrame': 'perioperative', 'description': 'Blood samples will be taken including whole blood, serum, TruCulture, and PAXgene to assess proteins, DNA, and RNA.'}, {'measure': 'EEG Delirium Biomarkers', 'timeFrame': 'intraoperative', 'description': 'EEG burst suppression and alpha power will be analyzed for association with delirium.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Delirium', 'Sleep', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '39921932', 'type': 'DERIVED', 'citation': 'Freedman IG, Boncompte G, Qu JZ, Khawaja ZQ, Turco I, Mueller A, Wiredu K, McKay TB, Westover MB, Pedemonte JC, Akeju O. Anesthesia-induced electroencephalogram oscillations and perioperative outcomes in older adults undergoing cardiac surgery. J Clin Anesth. 2025 Mar;102:111770. doi: 10.1016/j.jclinane.2025.111770. Epub 2025 Feb 7.'}, {'pmid': '37535937', 'type': 'DERIVED', 'citation': 'Wiredu K, Mueller A, McKay TB, Behera A, Shaefi S, Akeju O. Sex Differences in the Incidence of Postoperative Delirium after Cardiac Surgery: A Pooled Analyses of Clinical Trials. Anesthesiology. 2023 Oct 1;139(4):540-542. doi: 10.1097/ALN.0000000000004656. No abstract available.'}, {'pmid': '36590787', 'type': 'DERIVED', 'citation': "Qu JZ, Mueller A, McKay TB, Westover MB, Shelton KT, Shaefi S, D'Alessandro DA, Berra L, Brown EN, Houle TT, Akeju O; MINDDS Study Team. Nighttime dexmedetomidine for delirium prevention in non-mechanically ventilated patients after cardiac surgery (MINDDS): A single-centre, parallel-arm, randomised, placebo-controlled superiority trial. EClinicalMedicine. 2022 Dec 24;56:101796. doi: 10.1016/j.eclinm.2022.101796. eCollection 2023 Feb."}, {'pmid': '29678977', 'type': 'DERIVED', 'citation': "Shelton KT, Qu J, Bilotta F, Brown EN, Cudemus G, D'Alessandro DA, Deng H, DiBiasio A, Gitlin JA, Hahm EY, Hobbs LE, Houle TT, Ibala R, Loggia ML, Pavone KJ, Shaefi S, Tolis G, Westover MB, Akeju O. Minimizing ICU Neurological Dysfunction with Dexmedetomidine-induced Sleep (MINDDS): protocol for a randomised, double-blind, parallel-arm, placebo-controlled trial. BMJ Open. 2018 Apr 20;8(4):e020316. doi: 10.1136/bmjopen-2017-020316."}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether, compared with placebo, the nighttime administration of a intravenous dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in extubated post-cardiac surgical patients.', 'detailedDescription': "Delirium is an acute brain dysfunction characterized by disturbances in attention, awareness, and cognition not explained by a preexisting neurocognitive disorder. Although the increased mortality rates ascribed to delirium remain debatable, delirium remains a leading cause of preventable morbidity in hospitalized elderly patients. It is also associated with prolonged hospitalization, prolonged institutionalization, and long-term cognitive deficits. Patients with pre-existing dementia, such as Alzheimer's disease, are especially vulnerable to developing delirium. The total healthcare cost attributable to delirium is estimated between $143 and $152 billion annually. In the United States, delirium occurs in approximately 80% of critically ill patients admitted to medical/surgical intensive care units (ICU), and 15% of patients admitted to cardiac surgical (CS) ICU. Most patients diagnosed with delirium also present with multiple comorbidities (sepsis, multi-organ failure) that significantly confound our understanding of this disease. Thus, to date, no pharmacological intervention to treat delirium has been identified.\n\nThere is mounting evidence to suggest that sleep deprivation may be a modifiable risk factor for the development of delirium. Presently, pharmacological treatment with no current medication (benzodiazepines, antipsychotics) induces natural sleep or reliably reduces the incidence of delirium. The investigators have found that biomimetic sleep, defined here as pharmacological induction of rapid eye movement sleep (REM) and non-REM (N1, N2, N3) sleep states using dexmedetomidine, can now be achieved in humans. The overall objective of this study is to evaluate the efficacy of biomimetic sleep in reducing the incidence and severity of delirium in extubated CSICU patients. The investigators will also assess for peri-operative electroencephalogram biomarkers of delirium, and the association between delirium and chronic neuroinflammation using positron emission tomography. The MINDDS study is poised to enable therapeutic and diagnostic discoveries to aid the care of elderly patients who are at risk for developing postoperative delirium."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 60\n* Scheduled for a cardiac surgical procedure with planned post-operative admission to the CSICU for ≥ 24 hours\n* Scheduled same day surgical admission\n\nExclusion Criteria:\n\n* Blind, deafness or the inability to speak English\n* Greater than 2 days of ICU admission in the month preceding the current surgical procedure\n* Renal and liver failure requiring dialysis or Child-Pugh score \\> 5\n* Follow-up difficulties (i.e. active substance abuse, psychotic disorder, homelessness)\n* Previous cardiac surgery within 1 year of surgical procedure\n* Allergy to dexmedetomidine\n* Chronic therapy with benzodiazepines and/or antipsychotics\n* Severe deficit due to structural or anoxic brain damage\n* Surgical procedure requiring total circulatory arrest\n\nObjective Drop Criteria\n\n* Scheduled for a second surgical procedure during hospital stay\n* Post-operative intubation \\> 12 hours'}, 'identificationModule': {'nctId': 'NCT02856594', 'acronym': 'MINDDS', 'briefTitle': 'Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS): A Randomized Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '2016P000742'}, 'secondaryIdInfos': [{'id': '1R01AG053582', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG053582', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine-induced sleep', 'description': 'Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Dexmedetomidine', 'armGroupLabels': ['Dexmedetomidine-induced sleep']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal Saline'], 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Immediately', 'ipdSharing': 'YES', 'accessCriteria': 'De-identified data and a data dictionary will be made available upon reasonable request to researchers who provide a methodologically sound proposal and whose use of the data has been approved the study authors. Data will be made available immediately following publication, with no anticipated end date, to achieve the aims specified in the approved proposal. Proposals should be directed to oluwaseun.akeju@mgh.harvard.edu.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Anesthesia', 'investigatorFullName': 'Oluwaseun Johnson-Akeju, MD, MMSc', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}