[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04934683":3,"trial-entities:NCT04934683":145,"trial-summary:NCT04934683":148},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":51,"secondary_outcomes":56,"sex":61,"minimum_age":62,"maximum_age":15,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":68,"locations":71,"central_contacts":138,"overall_officials":139,"references":143,"see_also_links":144},"NCT04934683","HSC-MS-24-1026 (induction)","The GUARDIAN Trial - Induction Agent Sub-Study","Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications: The GUARDIAN Trial (Induction Agent Sub-Study Comparing Etomidate and Propofol)","ENROLLING_BY_INVITATION","2027-04-25","2025-07","2025-08-29","2021-07-25","The University of Texas Health Science Center, Houston","OTHER",null,"This is a sub-study of the overall GUARDIAN trial (NCT04884802) in which some GUARDIAN trial participants will be additionally randomized to etomidate vs propofol for anesthetic induction.","Participants in the underlying GUARDIAN trial (NCT04884802) will be randomized to: 1) routine intraoperative blood pressure management (routine pressure management); or 2) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management). Participants in this sub-study will be additionally randomized to etomidate or propofol for induction of anesthesia.",[19],"Major Surgery",[],"INTERVENTIONAL","PREVENTION",[24],"PHASE4",{"count":26,"type":27},6254,"ESTIMATED",[29,36,42,47],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","Routine Blood Pressure Management","Routine blood pressure control.",[34,35],"Routine Blood Pressure Management and Etomidate Induction","Routine Blood Pressure Management and Propofol Induction",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Tight Blood Pressure Management","Tight blood pressure control.",[40,41],"Tight Blood Pressure Management and Etomidate Induction","Tight Blood Pressure Management and Propofol Induction",{"type":43,"name":44,"description":45,"armGroupLabels":46},"DRUG","Etomidate Induction","Anesthetic induction with etomidate.",[34,40],{"type":43,"name":48,"description":49,"armGroupLabels":50},"Propofol Induction","Anesthetic induction with propofol.",[35,41],[52],{"measure":53,"description":54,"timeFrame":55},"Number of Participants with a Composite of Major Perfusion-Related Complications","The primary outcome is a composite of major perfusion-related complications (myocardial injury, stroke, non-fatal cardiac arrest, Stage 2-3 acute kidney injury, deep or organ-space infection, sepsis, and death) in the 30 days after major non-cardiac surgery.","During the initial 30 days after major non-cardiac surgery",[57],{"measure":58,"description":59,"timeFrame":60},"Number of Participants with Postoperative Delirium","The Postoperative Delirium Three-dimensional Confusion Assessment Method (3D CAM) will be used to assess for the presence of delirium over the initial four postoperative days.","During the initial 4 postoperative days","ALL","45 Years",false,{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"Inclusion Criteria:\n\n1. At least 45 years old;\n2. Scheduled for major noncardiac surgery expected to last at least 2 hours;\n3. Having general anesthesia, neuraxial anesthesia, or the combination;\n4. Expected to require at least overnight hospitalization (planned ICU admission is acceptable);\n5. Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life);\n6. Expected to have direct intraoperative blood pressure monitoring with an arterial catheter;\n7. Cared for by clinicians willing to follow the GUARDIAN protocol;\n8. Subject to at least one of the following risk factors:\n\n   1. Age \\>65 years;\n   2. History of peripheral arterial disease;\n   3. History of coronary artery disease;\n   4. History of stroke or transient ischemic attack;\n   5. Serum creatinine \\>175 μmol\u002FL (\\>2.0 mg\u002Fdl) within 6 months;\n   6. Diabetes requiring medication;\n   7. Current smoking or 15 pack-year history of smoking tobacco;\n   8. Scheduled for major vascular surgery;\n   9. Body mass index ≥35 kg\u002Fm2;\n   10. Preoperative high-sensitivity troponin T \\>14 ng\u002FL or troponin I equivalent, defined as ≥15 ng\u002FL (Abbott assay), 19 ng\u002FL (Siemens assay, \\[Borges, unpublished\\]), or 25% of the 99% percentile for other assays - all within 6 months;\n   11. B-type natriuretic protein (BNP) \\>80 ng\u002FL or N-terminal B-type natriuretic protein (NTProBNP) \\>200 ng\u002FL within six months.\n\nExclusion Criteria:\n\n1. Are scheduled for carotid artery surgery;\n2. Are scheduled for intracranial surgery;\n3. Are scheduled for partial or complete nephrectomy;\n4. Are scheduled for pheochromocytoma surgery;\n5. Are scheduled for liver or kidney transplantation;\n6. Require preoperative intravenous vasoactive medications;\n7. Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;\n8. Require beach-chair positioning;\n9. Have a documented history of dementia;\n10. Have language, vision, or hearing impairments that may compromise cognitive assessments;\n11. Have contraindications to norepinephrine or phenylephrine per clinician judgement;\n12. Have previously participated in the GUARDIAN trial.",[69,70],"ADULT","OLDER_ADULT",[72,81,89,93,97,106,112,115,118,124,131],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"University of Nebraska Medical Center","Omaha","Nebraska","68198","United States",{"lat":79,"lon":80},41.25626,-95.94043,{"facility":82,"city":83,"state":84,"zip":85,"country":77,"geoPoint":86},"MetroHealth Medical Center","Cleveland","Ohio","44109",{"lat":87,"lon":88},41.4995,-81.69541,{"facility":90,"city":83,"state":84,"zip":91,"country":77,"geoPoint":92},"Cleveland Clinic Fairview Hospital","44111",{"lat":87,"lon":88},{"facility":94,"city":83,"state":84,"zip":95,"country":77,"geoPoint":96},"Cleveland Clinic Main Campus","44195",{"lat":87,"lon":88},{"facility":98,"city":99,"state":100,"zip":101,"country":102,"geoPoint":103},"Shanghai Ninth People's Hospital","Shanghai","Shanghai Municipality","200025","China",{"lat":104,"lon":105},31.22222,121.45806,{"facility":107,"city":108,"country":102,"geoPoint":109},"Beijing Shijitan Hospital, Capital Medical University","Beijing",{"lat":110,"lon":111},39.9075,116.39723,{"facility":113,"city":108,"country":102,"geoPoint":114},"Peking Union Medical College Hospital",{"lat":110,"lon":111},{"facility":116,"city":99,"country":102,"geoPoint":117},"Shanghai Chest Hospital",{"lat":104,"lon":105},{"facility":119,"city":120,"country":102,"geoPoint":121},"West China Hospital","Sichuan",{"lat":122,"lon":123},35.1221,105.48032,{"facility":125,"city":126,"country":127,"geoPoint":128},"University of Thessaly","Larissa","Greece",{"lat":129,"lon":130},39.62847,22.42112,{"facility":132,"city":133,"country":134,"geoPoint":135},"National Defense College","Tokyo","Japan",{"lat":136,"lon":137},35.6895,139.69171,[],[140],{"name":141,"affiliation":13,"role":142},"Daniel I Sessler, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":146,"biomarkers":147},[19],[],{"nct_id":4,"found":149,"summary":150,"prompt_version":160},true,{"design":151,"status":152,"heading":153,"summary":154,"follow_up":155,"word_count":156,"commitments":157,"compensation":158,"drugs_mentioned":159},"This interventional study involves participants being randomly assigned to receive either etomidate or propofol for anesthesia induction, in addition to different blood pressure management strategies. It plans to enroll 6254 participants.","completed","The GUARDIAN Trial - Induction Agent Sub-Study for Major Surgery","This study is looking at different ways to manage blood pressure and anesthesia during major surgery. It's a sub-study of a larger trial, and it specifically compares two anesthetic medications: etomidate and propofol. Researchers want to see if one of these medications, when used for anesthesia induction (the start of anesthesia), leads to fewer major complications related to blood flow after surgery. You might be able to join if you are at least 45 years old, scheduled for major non-heart surgery expected to last at least two hours, and will have general or neuraxial anesthesia. The study aims to enroll 6254 participants, but its current status is unclear.","Participants will be followed for 30 days after major non-cardiac surgery to check for major perfusion-related complications.",108,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]