Nctid:
NCT06613178
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000071257", "term"=>"Emergence Delirium"}, {"id"=>"D000010149", "term"=>"Pain, Postoperative"}, {"id"=>"D000011183", "term"=>"Postoperative Complications"}], "ancestors"=>[{"id"=>"D000003693", "term"=>"Delirium"}, {"id"=>"D000003221", "term"=>"Confusion"}, {"id"=>"D000019954", "term"=>"Neurobehavioral Manifestations"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000019965", "term"=>"Neurocognitive Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000010146", "term"=>"Pain"}], "browseLeaves"=>[{"id"=>"M13069", "name"=>"Pain, Postoperative", "asFound"=>"Post Operative Pain", "relevance"=>"HIGH"}, {"id"=>"M14065", "name"=>"Postoperative Complications", "asFound"=>"Post-Op Complication", "relevance"=>"HIGH"}, {"id"=>"M6894", "name"=>"Delirium", "relevance"=>"LOW"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M772", "name"=>"Emergence Delirium", "asFound"=>"Post-operative Delirium", "relevance"=>"HIGH"}, {"id"=>"M6446", "name"=>"Confusion", "relevance"=>"LOW"}, {"id"=>"M21826", "name"=>"Neurobehavioral Manifestations", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M21836", "name"=>"Neurocognitive Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000000082", "term"=>"Acetaminophen"}], "ancestors"=>[{"id"=>"D000018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000000700", "term"=>"Analgesics"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000058633", "term"=>"Antipyretics"}], "browseLeaves"=>[{"id"=>"M2340", "name"=>"Acetaminophen", "asFound"=>"Side", "relevance"=>"HIGH"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}, {"id"=>"M29176", "name"=>"Antipyretics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antipyretics", "abbrev"=>"Antipy"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"Quadruple. blinded medication with codes kept by pharmacy director"}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"randomized double blind double dummy two arm study"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>1100}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-07-02", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2027-12-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-03-01", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-07-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"post operative delirium", "timeFrame"=>"up to 7 days", "description"=>"measured with CAMICU or CAM"}], "secondaryOutcomes"=>[{"measure"=>"total use of opioids", "timeFrame"=>"up to 7 days", "description"=>"measured for 7 days or until hospital discharge"}, {"measure"=>"Cognitive function at 6 months and 1 year", "timeFrame"=>"6 months and 1 year", "description"=>"Measured with Montreal Cognitive assessment score."}, {"measure"=>"Time in intensive care unit", "timeFrame"=>"up to 7 days", "description"=>"measured in hours"}, {"measure"=>"time in hospital", "timeFrame"=>"up to 7 days", "description"=>"measured in days"}, {"measure"=>"time to extubation", "timeFrame"=>"up to 7 days", "description"=>"measured in hours"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["pain", "post-operative care", "cardiac surgery", "narcotic", "acetaminophen"], "conditions"=>["Post Operative Delirium", "Post Operative Pain", "Post-Op Complication", "Post-cardiac Surgery"]}, "descriptionModule"=>{"briefSummary"=>"Double blind, double dummy trial of the use of IV acetaminophen versus oral acetaminophen for the prevention of delirium after cardiac surgery. The underlying hypothesis is that better pain control and less use of narcotics will lead to a lower incidence of delirium from day 1 to 7 following cardiac surgery. Other important secondary outcomes are the total use of narcotics, ICU and hospital stay, improved cognitive function at 6 months and 1 year post surgery, NSAID use at each centre and associated NSAID complications.", "detailedDescription"=>"Patients \\> or equal to 18 years of going for elective cardiac surgery will be randomized to receive IV either IV acetaminophen and an oral placebo acetaminophen or an IV placebo acetaminophen (saline) and oral acetaminophen every 6 hours for 48 hours after cardiac surgery. the study will be performed at 8 large Canadian cardiac surgery centres. All other therapy will be as per standard procedures (pragmatic) at the institutions including including use of their standard opioid protocol. The primary end-point is the development of delirium as assessed by Confusion Assessment Method in the Intensive Care unit (CAMICU) and the CAM on the regular floor unit for up to 7 days after surgery or discharge if it is sooner. Other measures are change from pre-operative cognitive function as assessed by the Montreal Cognitive Assessment score (MoCA) at 6 months and 1 year, numeric pain score, total opioid use, hospital and ICU length of stay. Use of opioids and pain score at 1 year also will be assessed. Patients will be stratified by site and sex.\n\nWe also will assess use of NSAID, specifically ketorolac, and any NSAID associated events."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\ngreater or equal to 18\n\n* elective cardiac surgery\n* stable pre-operative\n* aorto-coronary bypass with or without 1 valve replacement.\n\nExclusion Criteria:\n\nRefusal by surgeon Requested late extubation by surgeon or anesthesia Intra-aortic balloon pump Mechanical cardiac support Sensitivity to acetaminophen Psychiatric history with current active treatment Alzheimer\\'s disease Seizure in previous 6 months Recent history of alcohol misuse Cognitive impairment\n\n-"}, "identificationModule"=>{"nctId"=>"NCT06613178", "acronym"=>"IVACS", "briefTitle"=>"Intravenous Acetaminophen After Cardiac Surgery - Definitive Study", "organization"=>{"class"=>"OTHER", "fullName"=>"McGill University Health Centre/Research Institute of the McGill University Health Centre"}, "officialTitle"=>"Intravenous Acetaminophen After Cardiac Surgery", "orgStudyIdInfo"=>{"id"=>"MUHC-ACETAMINOPHEN FULL STUDY"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Oral Placebo", "description"=>"Subject receives active intravenous acetaminophen and oral placebo acetaminophen", "interventionNames"=>["Drug: acetaminophen"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Oral Acetaminophen", "description"=>"Subject receives placebo IV fluid (saline) and active oral acetaminophen", "interventionNames"=>["Drug: acetaminophen"]}], "interventions"=>[{"name"=>"acetaminophen", "type"=>"DRUG", "otherNames"=>["placebo"], "description"=>"Patient receive IV acetaminophen (and oral placebo) or placebo IV acetaminophen and oral acetaminophen. All drugs are blinded", "armGroupLabels"=>["Oral Acetaminophen", "Oral Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"V6T 1Z4", "city"=>"Vancouver", "state"=>"British Columbia", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"Canada", "facility"=>"University of British Columbia", "geoPoint"=>{"lat"=>49.24966, "lon"=>-123.11934}}, {"zip"=>"R3T2N2", "city"=>"Winnipeg", "state"=>"Manitoba", "status"=>"RECRUITING", "country"=>"Canada", "contacts"=>[{"name"=>"Rakesh Arora, MD PhD", "role"=>"CONTACT", "email"=>"rakesh.arora@uhhospitals.org", "phone"=>"2165082112"}], "facility"=>"University of Manitoba", "geoPoint"=>{"lat"=>49.8844, "lon"=>-97.14704}}, {"zip"=>"L5B2V2", "city"=>"Mississagua", "state"=>"Ontario", "status"=>"NOT_YET_RECRUITING", "country"=>"Canada", "contacts"=>[{"name"=>"Bill Wong, MD", "role"=>"CONTACT", "email"=>"bill.wong@thp.ca", "phone"=>"905-848-7178"}], "facility"=>"Trillium Health Centre"}, {"zip"=>"K1N6N5", "city"=>"Ottawa", "state"=>"Ontario", "status"=>"NOT_YET_RECRUITING", "country"=>"Canada", "contacts"=>[{"name"=>"Bernard McDonald, MD MSc", "role"=>"CONTACT", "email"=>"Bbmcdonald@ottawaheart.ca", "phone"=>"613-612-5412"}], "facility"=>"University of Ottawa", "geoPoint"=>{"lat"=>45.41117, "lon"=>-75.69812}}, {"zip"=>"M4N3M5", "city"=>"Toronto", "state"=>"Ontario", "status"=>"NOT_YET_RECRUITING", "country"=>"Canada", "contacts"=>[{"name"=>"Neill Adhikari, MD MSc", "role"=>"CONTACT", "email"=>"neill.adhikari@sunnybrook.ca", "phone"=>"416-480-4522"}], "facility"=>"Sunnybroook Health Centre", "geoPoint"=>{"lat"=>43.70011, "lon"=>-79.4163}}, {"zip"=>"H4A 3J1", "city"=>"Montreal", "state"=>"Quebec", "status"=>"RECRUITING", "country"=>"Canada", "contacts"=>[{"name"=>"SHELDON magder, MD", "role"=>"CONTACT", "email"=>"sheldon.magder@mcgill.ca", "phone"=>"5149475918"}, {"name"=>"Rayhaneh Rahgoshai, BA", "role"=>"CONTACT", "phone"=>"5149341934"}], "facility"=>"McGill Universtiy Health Centre", "geoPoint"=>{"lat"=>45.50884, "lon"=>-73.58781}}, {"zip"=>"R3T2N2", "city"=>"Montreal", "state"=>"Quebec", "status"=>"RECRUITING", "country"=>"Canada", "contacts"=>[{"name"=>"Yoan Lamarche, MD, PhD", "role"=>"CONTACT", "email"=>"yoanlamarche@gmail.com", "phone"=>"514 991-3845"}], "facility"=>"Universite Montreal", "geoPoint"=>{"lat"=>45.50884, "lon"=>-73.58781}}, {"zip"=>"G1V0A6", "city"=>"Quebec City", "state"=>"Quebec", "status"=>"RECRUITING", "country"=>"Canada", "contacts"=>[{"name"=>"Siamak Mohammadi, MD", "role"=>"CONTACT", "email"=>"siamak.mohammadi@fmed.ulaval.ca", "phone"=>"1 418-656-4717"}], "facility"=>"University of Laval", "geoPoint"=>{"lat"=>46.81228, "lon"=>-71.21454}}], "centralContacts"=>[{"name"=>"Sheldon Magder, MD", "role"=>"CONTACT", "email"=>"sheldon.magder@mcgill.ca", "phone"=>"5149475918"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"If the investigators of PANDORA complete their study we would request to combine our studies in a meta-analysis"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"McGill University Health Centre/Research Institute of the McGill University Health Centre", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Laval University", "class"=>"OTHER"}, {"name"=>"University of British Columbia", "class"=>"OTHER"}, {"name"=>"St. Boniface Hospital", "class"=>"OTHER"}, {"name"=>"University of Ottawa", "class"=>"OTHER"}, {"name"=>"Trillium Health Centre", "class"=>"OTHER"}, {"name"=>"Université de Montréal", "class"=>"OTHER"}, {"name"=>"Sunnybrook Health Sciences Centre", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principle Investigator", "investigatorFullName"=>"magder sheldon", "investigatorAffiliation"=>"McGill University Health Centre/Research Institute of the McGill University Health Centre"}}}}
