Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-02 @ 2:31 AM
Study NCT ID:
NCT00041392
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2002-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Magnesium on Individuals Undergoing Coronary Artery Bypass Graft Surgery
Sponsor:
Organization:
Raw JSON
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Newman', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Magnesium', 'description': '100 mg/kg magnesium', 'otherNumAtRisk': 198, 'otherNumAffected': 137, 'seriousNumAtRisk': 198, 'seriousNumAffected': 37}, {'id': 'EG001', 'title': '0.9 % Saline', 'description': '100 mg/kg 0.9 % saline', 'otherNumAtRisk': 191, 'otherNumAffected': 109, 'seriousNumAtRisk': 191, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Renal Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 10}], 'organSystem': 'Cardiac disorders'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 7}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 66}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pacemaker placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'GI bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Small bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 10, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Reexploration for bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Sternal wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 14, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Renal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cognitive Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnesium', 'description': '100 mg/kg magnesium'}, {'id': 'OG001', 'title': '0.9 % Saline', 'description': '100 mg/kg 0.9 % saline'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and 6 weeks', 'description': 'To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the cognitive test scores from baseline. We chose a four-factor solution, which represents 4 cognitive domains: verbal memory, abstraction and visuo-spatial orientation (executive function), visual memory and attention and concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 4 preoperative domain scores. The cognitive index score has a mean of zero and standard deviation of 0.5. Thus, any positive score is above the mean, any negative score is below the mean, and a score of 0.5 represents 1 SD above the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. Negative scores indicate decline and positive scores indicate improvement.', 'unitOfMeasure': 'Continuous cognitive change score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Magnesium', 'description': '100 mg/kg magnesium'}, {'id': 'FG001', 'title': '0.9 % Saline', 'description': '100 mg/kg 0.9 % saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '191'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '191'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Hospital and preoperative clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Magnesium', 'description': '100 mg/kg magnesium'}, {'id': 'BG001', 'title': '0.9 % Saline', 'description': '100 mg/kg 0.9 % saline'}, {'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': '78', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '68.4', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '68.5', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 389}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-25', 'studyFirstSubmitDate': '2002-07-08', 'resultsFirstSubmitDate': '2012-08-05', 'studyFirstSubmitQcDate': '2002-07-08', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-27', 'studyFirstPostDateStruct': {'date': '2002-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Function', 'timeFrame': 'Measured at baseline and 6 weeks', 'description': 'To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the cognitive test scores from baseline. We chose a four-factor solution, which represents 4 cognitive domains: verbal memory, abstraction and visuo-spatial orientation (executive function), visual memory and attention and concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 4 preoperative domain scores. The cognitive index score has a mean of zero and standard deviation of 0.5. Thus, any positive score is above the mean, any negative score is below the mean, and a score of 0.5 represents 1 SD above the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. Negative scores indicate decline and positive scores indicate improvement.'}]}, 'conditionsModule': {'conditions': ['Coronary Disease', 'Heart Diseases', 'Cardiovascular Diseases', 'Neurologic Manifestations']}, 'referencesModule': {'references': [{'pmid': '24105697', 'type': 'DERIVED', 'citation': 'Mathew JP, White WD, Schinderle DB, Podgoreanu MV, Berger M, Milano CA, Laskowitz DT, Stafford-Smith M, Blumenthal JA, Newman MF; Neurologic Outcome Research Group (NORG) of The Duke Heart Center. Intraoperative magnesium administration does not improve neurocognitive function after cardiac surgery. Stroke. 2013 Dec;44(12):3407-13. doi: 10.1161/STROKEAHA.113.002703. Epub 2013 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of supplemental magnesium on the neurocognitive function of individuals undergoing coronary artery bypass graft (CABG) surgery.', 'detailedDescription': 'BACKGROUND:\n\nApproximately 400,000 individuals undergo heart operations each year and cognitive impairment occurs frequently following surgery. An increasing number of these individuals are elderly and are particularly susceptible to cognitive dysfunction following surgery. Cognitive impairment is most notable in the early stages following heart surgery, but it may persist in some individuals. While many people think cognitive impairment is subtle, transient, or subclinical, perioperative decline is associated with 5-year cognitive deterioration and reduced quality of life. Multiple strategies, both clinical and pharmacological, have been proposed to reduce the central nervous system dysfunction associated with heart surgery. However, most strategies have been unsuccessful, met with limited success, or are unrealistic from a cost or risk-benefit ratio for the majority of people. This study will examine the effectiveness of supplemental magnesium at preventing the cognitive decline associated with heart surgery.\n\nDESIGN NARRATIVE:\n\nThis study will examine the effect of supplemental magnesium on the neurocognitive function of individuals undergoing CABG surgery. The two hypotheses to be tested include the following: 1) therapeutic levels of magnesium reduce post-operative neurocognitive dysfunction after heart surgery; and 2) therapeutic magnesium levels protect quality of life through reduced cognitive dysfunction after heart surgery. This double-blind study will enroll 400 individuals and randomly assign them to either the treatment group, which will receive 100 mg/kg of magnesium, or to the control group. Anesthesia management will be standardized to minimize any impact that anesthesia may have on neurologic or neuropsychologic outcome. Neurocognitive testing will be conducted prior to surgery, and 6 weeks and 1 year following surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary heart disease\n\nExclusion Criteria:\n\n* Early dementia\n* History of psychiatric illness'}, 'identificationModule': {'nctId': 'NCT00041392', 'acronym': 'POINT', 'briefTitle': 'Effects of Magnesium on Individuals Undergoing Coronary Artery Bypass Graft Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'PeriOperative Interventional Neuroprotection Trial (POINT)', 'orgStudyIdInfo': {'id': 'Pro00007128'}, 'secondaryIdInfos': [{'id': 'R01HL069081', 'link': 'https://reporter.nih.gov/quickSearch/R01HL069081', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Magnesium', 'description': '100 mg/kg magnesium', 'interventionNames': ['Drug: Magnesium']}, {'type': 'PLACEBO_COMPARATOR', 'label': '0.9 % saline', 'description': '100 mg/kg 0.9 % saline', 'interventionNames': ['Drug: 0.9% saline']}], 'interventions': [{'name': 'Magnesium', 'type': 'DRUG', 'description': '100 mg/kg', 'armGroupLabels': ['Magnesium']}, {'name': '0.9% saline', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['0.9 % saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Mark F. Newman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}