Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT02119806
Status:
WITHDRAWN
Last Update Posted:
2018-06-12
First Post:
2014-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decreasing the Incidence of Delirium After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was never initiated.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-08', 'studyFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2014-04-21', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delirium', 'timeFrame': 'less than 2 minutes', 'description': 'Delirium can now be reliably diagnosed by non-psychiatrists in critically ill patients in less than 2 minutes through the use of validated monitoring instruments such as the Confusion Assessment Method for the ICU (CAM-ICU)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac surgery, benzodiazepines, delirium'], 'conditions': ['C.Surgical Procedure; Cardiac', 'Delirium']}, 'referencesModule': {'references': [{'pmid': '11730446', 'type': 'BACKGROUND', 'citation': 'Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.'}, {'pmid': '11797025', 'type': 'BACKGROUND', 'citation': 'Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.'}, {'pmid': '15082703', 'type': 'BACKGROUND', 'citation': 'Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.'}, {'pmid': '19745202', 'type': 'BACKGROUND', 'citation': 'Pisani MA, Kong SY, Kasl SV, Murphy TE, Araujo KL, Van Ness PH. Days of delirium are associated with 1-year mortality in an older intensive care unit population. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1092-7. doi: 10.1164/rccm.200904-0537OC. Epub 2009 Sep 10.'}, {'pmid': '20473145', 'type': 'BACKGROUND', 'citation': 'Girard TD, Jackson JC, Pandharipande PP, Pun BT, Thompson JL, Shintani AK, Gordon SM, Canonico AE, Dittus RS, Bernard GR, Ely EW. Delirium as a predictor of long-term cognitive impairment in survivors of critical illness. Crit Care Med. 2010 Jul;38(7):1513-20. doi: 10.1097/CCM.0b013e3181e47be1.'}, {'pmid': '15071384', 'type': 'BACKGROUND', 'citation': 'Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.'}]}, 'descriptionModule': {'briefSummary': 'In critically ill surgical patients, delirium (confusion and disorientation) is extremely common and is associated with longer hospital length of stay, mortality, cost, and long term cognitive impairment. The goal of the study is to establish whether benzodiazepines (a sedative, anti-anxiety drug) should be used as part of standard of care or be eliminated by comparing the chances of delirium in cardiac surgery patients between two groups: a group that receives benzodiazepines during surgery versus a group that does not receive benzodiazepines during surgery. Benzodiazepines have historically been used in cardiac anesthesia to decrease the risk of anesthesia awareness. The current standard of care is to keep the patient on inhaled anesthesia throughout the surgery which eliminates the need for intraoperative use of benzodiazepines. Benzodiazepines are still used based on practitioner preference. Findings of this study will allow all anesthesiologists to make more informed decisions about what level of care our patients need.', 'detailedDescription': 'In critically ill surgical patients, delirium is extremely common and is associated with longer hospital length of stay, mortality, cost, and long term cognitive impairment. Benzodiazepine usage is common in anesthetic practice, and ICU literature demonstrates that limiting post-operative benzodiazepines decreases the incidence of delirium. However, the avoidance of preoperative and intraoperative benzodiazepines during cardiac surgery has not been studied in terms of its effect on delirium. The goal of the study is establish whether benzodiazepines should be used as part of standard of care or be eliminated by comparing the incidence of delirium in cardiac surgical patients when randomized to a group that receives benzodiazepines versus a group that does not receive benzodiazepines.\n\nPotential subjects will be identified and recruited the day before surgery by primary investigators. Patients undergoing coronary artery bypass grafting or single valve procedures that consent to participate will be enrolled in the study. These patients may be consented during the pre-operative period. Patients will be informed that whether they enroll in the study or not, they will be receiving standard clinical care. Only subjects meeting all inclusion criteria and requirements for continuation in the study will be consented.\n\nPatient will be randomized by age (age is a predictor of delirium) to 3 groups:\n\n* \\>80 years of age;\n* 70-80 years of age;\n* \\< 70 years of age.\n\nWithin these 3 groups, patients will be randomized to receive benzodiazepines during cardiac surgery or not. The anesthesiologist in the operating room will not be blinded to the group; however, the intensive care physician evaluating for delirium will be blinded to the treatment groups.\n\nBenzodiazepine group:\n\n1. Premedication 0.02mg/kg-0.1mg/kg of midazolam;\n2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;\n3. Postoperative 10-100mcg/kg/min of propofol\n\nNon-benzodiazepine group:\n\n1. Premedication 0-50mg of propofol and/or 0-250mcg of fentanyl;\n2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;\n3. Postoperative 10-100mcg/kg/min of propofol\n\nDelirium can now be reliably diagnosed by non-psychiatrists in critically ill patients in less than 2 minutes through the use of validated monitoring instruments such as the Confusion Assessment Method for the ICU (CAM-ICU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients' undergoing coronary artery bypass grafting or single valve procedures.\n\nExclusion Criteria:\n\n* Patients who have baseline cognitive dysfunction,\n* Patients with hearing problems,\n* Patients currently on benzodiazepines"}, 'identificationModule': {'nctId': 'NCT02119806', 'briefTitle': 'Decreasing the Incidence of Delirium After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Decreasing the Incidence of Delirium After Cardiac Surgery', 'orgStudyIdInfo': {'id': 'Delirium 13-001412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Benzodiazepine group', 'description': '1. Premedication 0.02mg/kg-0.1mg/kg of Benzodiazepine ;\n2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;\n3. Postoperative 10-100mcg/kg/min of propofol', 'interventionNames': ['Drug: Benzodiazepine', 'Drug: Fentanyl', 'Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-benzodiazepine group', 'description': '1. Premedication 0-50mg of propofol and/or 0-250mcg of fentanyl;\n2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;\n3. Postoperative 10-100mcg/kg/min of propofol', 'interventionNames': ['Drug: Fentanyl', 'Drug: Propofol']}], 'interventions': [{'name': 'Benzodiazepine', 'type': 'DRUG', 'otherNames': ['Midazolam', 'Versed'], 'description': 'Receive as premedication in the Benzodiazepine group.', 'armGroupLabels': ['Benzodiazepine group']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Fentanil'], 'description': 'Receive as maintenance in the Benzodiazepine group. Can receive as premedication in the Non-Benzodiazepine group. Receive as maintenance in the Non-Benzodiazepine group.', 'armGroupLabels': ['Benzodiazepine group', 'Non-benzodiazepine group']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'description': 'Receive postoperatively in the Benzodiazepine group. Can receive as premedication in the Non-Benzodiazepine group. Receive postoperatively in the Non-Can receive as premedication in the Non-Benzodiazepine group.', 'armGroupLabels': ['Benzodiazepine group', 'Non-benzodiazepine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center, Department of Anesthesiology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Jacques Neelankavil, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'HS Assistant Clinical Professor', 'investigatorFullName': 'Jacques Neelankavil', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}