Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
6254 participants
INTERVENTIONAL
2021-07-25
2027-04-25
Brief Summary
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The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management (routine pressure management).
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Detailed Description
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Tight pressure management: In patients assigned to tight pressure management, angiotensin converting enzyme inhibitors and angiotensin receptor blockers will not be given the morning of surgery. Other chronic antihypertensives will only be given as necessary to treat hypertension. General anesthesia will be induced with propofol or etomidate which will be given in repeated small boluses or target-controlled infusion in an effort to keep mean arterial pressure ≥85 mmHg. Simultaneously, the vasopressor infusion will be adjusted with the same goal. Anesthetic dose, fluid administration, and vasopressor administration will be adjusted with the goal of maintaining the individual designated baseline mean arterial pressure. Invasive or non-invasive advanced hemodynamic monitoring is not required, but should be used when practical. Clinicians should use available information to optimize vascular volume, afterload, and inotropy.
Routine pressure management: In patients assigned to routine pressure management, ACEIs, ARBs, and/or calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist. General anesthesia will be induced and maintained per routine.
In both groups, other aspects of anesthetic management will be at the discretion of the responsible anesthesiologist, including the types and volumes of various fluids. Volatile or intravenous anesthesia is permitted. There will be no limitation on ancillary vasoactive, chronotropic, and inotropic drugs. Clinicians will be free to use advanced hemodynamic monitoring (e.g., pulse-wave analysis, esophageal Doppler, etc.). Blood products will be given per routine. Similarly, postoperative analgesic management will be per routine and clinician preference. Neuraxial and peripheral nerve blocks are permitted, but epidural catheters should not be activated until surgery is nearly finished.
In all cases, good judgement will predominate.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Tight blood pressure management
In patients assigned to tight blood pressure control, angiotensin converting enzyme inhibitors and angiotensin receptor blockers will not be given the morning of surgery. Other chronic antihypertensives will only be given as necessary to treat hypertension. Norepinephrine or phenylephrine infusion will be infused at a rate sufficient to maintain intraoperative MAP ≥ 85 mmHg.
Tight blood pressure management
Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg.
Routine blood pressure management
ACEIs, ARBs, and/or calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist. Intraoperative blood pressure will be managed per clinical routine.
Routine blood pressure management
ACEIs, ARBs, and/or calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist. Intraoperative blood pressure will be managed per clinical routine.
Interventions
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Tight blood pressure management
Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg.
Routine blood pressure management
ACEIs, ARBs, and/or calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist. Intraoperative blood pressure will be managed per clinical routine.
Eligibility Criteria
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Inclusion Criteria
2. Scheduled for major noncardiac surgery expected to last at least 2 hours;
3. Having general anesthesia, neuraxial anesthesia, or the combination;
4. Expected to require at least overnight hospitalization (planned ICU admission is acceptable);
5. Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life);
6. Expected to have direct intraoperative blood pressure monitoring with an arterial catheter;
7. Cared for by clinicians willing to follow the GUARDIAN protocol;
8. Subject to at least one of the following risk factors:
1. Age \>65 years;
2. History of peripheral arterial disease;
3. History of coronary artery disease;
4. History of stroke or transient ischemic attack;
5. Serum creatinine \>175 μmol/L (\>2.0 mg/dl) within 6 months;
6. Diabetes requiring medication;
7. Current smoking or 15 pack-year history of smoking tobacco;
8. Scheduled for major vascular surgery;
9. Body mass index ≥35 kg/m2;
10. Preoperative high-sensitivity troponin T \>14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay), 19 ng/L (Siemens assay, \[Borges, unpublished\]), or 25% of the 99% percentile for other assays - all within 6 months;
11. B-type natriuretic protein (BNP) \>80 ng/L or N-terminal B-type natriuretic protein (NTProBNP) \>200 ng/L within six months.
Exclusion Criteria
2. Are scheduled for intracranial surgery;
3. Are scheduled for partial or complete nephrectomy;
4. Are scheduled for pheochromocytoma surgery;
5. Are scheduled for liver or kidney transplantation;
6. Require preoperative intravenous vasoactive medications;
7. Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
8. Require beach-chair positioning;
9. Have a documented history of dementia;
10. Have language, vision, or hearing impairments that may compromise cognitive assessments;
11. Have contraindications to norepinephrine or phenylephrine per clinician judgement;
12. Have previously participated in the GUARDIAN trial.
45 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Daniel Sessler
Professor and Vice President for Clinical and Outcomes Research
Principal Investigators
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Daniel I Sessler, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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University of Nebraska Medical Center
Omaha, Nebraska, United States
Wake Forest University
Wake Forest, North Carolina, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Beijing Shijitan Hospital, Capital Medical University
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
West China University Hospital
Chengdu, , China
Prince of Wales Hospital, Chinese University of Hong Kong, Shatin
Hong Kong, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Shanghai Chest Hospital
Shanghai, , China
Shanghai Ninth People's Hospital
Shanghai, , China
The Affiliated Lianyungang Hospital of Xuzhou Medical University
Xuzhou, , China
University of Thessaly
Larissa, , Greece
IRCCS Regina Elena National Cancer Institute
Rome, , Italy
National Defense Medical College
Tokyo, , Japan
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Bakırköy, , Turkey (Türkiye)
Konya City Hospital
Konya, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Dong-Xin Wang, MD
Role: primary
Xiao Liang, MD
Role: primary
Other Identifiers
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HSC-MS-24-1026
Identifier Type: -
Identifier Source: org_study_id
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