[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04934748":3,"trial-entities:NCT04934748":140,"trial-summary:NCT04934748":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":57,"minimum_age":58,"maximum_age":15,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":64,"locations":67,"central_contacts":133,"overall_officials":134,"references":138,"see_also_links":139},"NCT04934748","HSC-MS-24-1026 (vasopressor)","The GUARDIAN Trial - Vasopressor Sub-Study","Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications: The GUARDIAN Trial (Vasopressor Sub-study Comparing Phenylephrine and Norepinephrine)","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 norepinephrine or phenylephrine infusion to maintain the designated target intraoperative mean arterial pressure.","Participants in the underlying GUARDIAN trial (NCT04884802) will be randomized to: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management (routine pressure management). Participants in this sub-study will be additionally randomized to norepinephrine or phenylephrine infusion to maintain the designated target intraoperative mean arterial pressure.",[19],"Blood Pressure",[],"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 with Norepinephrine","Routine Blood Pressure Management with Phenylephrine",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Tight Blood Pressure Management","Tight blood pressure control.",[40,41],"Tight Blood Pressure Management with Norepinephrine","Tight Blood Pressure Management with Phenylephrine",{"type":43,"name":44,"description":45,"armGroupLabels":46},"DRUG","Phenylephrine","Phenylephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.",[35,41],{"type":43,"name":48,"description":49,"armGroupLabels":50},"Norepinephrine","Norepinephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.",[34,40],[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",[],"ALL","45 Years",false,{"inclusion":61,"exclusion":62,"raw_text":63},[],[],"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.",[65,66],"ADULT","OLDER_ADULT",[68,77,85,89,93,100,103,110,113,119,126],{"facility":69,"city":70,"state":71,"zip":72,"country":73,"geoPoint":74},"University of Nebraska Medical Center","Omaha","Nebraska","68198","United States",{"lat":75,"lon":76},41.25626,-95.94043,{"facility":78,"city":79,"state":80,"zip":81,"country":73,"geoPoint":82},"MetroHealth Medical Center","Cleveland","Ohio","44109",{"lat":83,"lon":84},41.4995,-81.69541,{"facility":86,"city":79,"state":80,"zip":87,"country":73,"geoPoint":88},"Cleveland Clinic Fairview Hospital","44111",{"lat":83,"lon":84},{"facility":90,"city":79,"state":80,"zip":91,"country":73,"geoPoint":92},"Cleveland Clinic Main Campus","44195",{"lat":83,"lon":84},{"facility":94,"city":95,"country":96,"geoPoint":97},"Beijing Shijitan Hospital, Capital Medical University","Beijing","China",{"lat":98,"lon":99},39.9075,116.39723,{"facility":101,"city":95,"country":96,"geoPoint":102},"Peking Union Medical College Hospital",{"lat":98,"lon":99},{"facility":104,"city":105,"zip":106,"country":96,"geoPoint":107},"Shanghai Ninth People's Hospital","Shanghai","200025",{"lat":108,"lon":109},31.22222,121.45806,{"facility":111,"city":105,"country":96,"geoPoint":112},"Shanghai Chest Hospital",{"lat":108,"lon":109},{"facility":114,"city":115,"country":96,"geoPoint":116},"West China Hospital","Sichuan",{"lat":117,"lon":118},35.1221,105.48032,{"facility":120,"city":121,"country":122,"geoPoint":123},"University of Thessaly","Larissa","Greece",{"lat":124,"lon":125},39.62847,22.42112,{"facility":127,"city":128,"country":129,"geoPoint":130},"National Defense College","Tokyo","Japan",{"lat":131,"lon":132},35.6895,139.69171,[],[135],{"name":136,"affiliation":13,"role":137},"Daniel I Sessler, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":141,"biomarkers":143},[142],"Major Noncardiac Surgery",[144,145,146,147],"NPPB wt Allele","N-Terminal Fragment Brain Natriuretic Protein","Troponin I","Troponin T",{"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 is an interventional study, meaning participants will receive specific treatments. It is a sub-study of a larger trial and plans to enroll 6254 participants.","completed","The GUARDIAN Trial - Vasopressor Sub-Study for Blood Pressure Management During Surgery","This study, called the GUARDIAN Trial - Vasopressor Sub-Study, is looking at the best way to manage blood pressure during major non-heart surgery. Researchers are comparing two approaches: routine blood pressure management versus tight blood pressure management. For some participants, they will also compare two medications, phenylephrine and norepinephrine, to maintain a specific blood pressure during surgery. The main goal is to see if one approach leads to fewer major complications related to blood flow (perfusion) within 30 days after surgery. You may be able to join if you are at least 45 years old and scheduled for major non-heart surgery expected to last at least 2 hours and require an overnight hospital stay. The study status is currently unclear.","Participants will be followed for 30 days after major non-cardiac surgery to check for complications.",120,"Participants will undergo either routine or tight blood pressure management during surgery. Some will also receive infusions of phenylephrine or norepinephrine during surgery.","Not stated in the trial record.",[31,37,44,48],"v2"]