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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ENROLLING_BY_INVITATION
PHASE4
6254 participants
INTERVENTIONAL
2021-07-25
2027-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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Routine Blood Pressure Management with Phenylephrine
Routine blood pressure control with phenylephrine infusion at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
Routine Blood Pressure Management
Routine blood pressure control.
Phenylephrine
Phenylephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
Routine Blood Pressure Management with Norepinephrine
Routine blood pressure control with norepinephrine infusion at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
Routine Blood Pressure Management
Routine blood pressure control.
Norepinephrine
Norepinephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
Tight Blood Pressure Management with Phenylephrine
TIiht blood pressure control with phenylephrine infusion at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial
Tight Blood Pressure Management
Tight blood pressure control.
Phenylephrine
Phenylephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
Tight Blood Pressure Management with Norepinephrine
Tight blood pressure control with norepinephrine infusion at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
Tight Blood Pressure Management
Tight blood pressure control.
Norepinephrine
Norepinephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
Interventions
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Routine Blood Pressure Management
Routine blood pressure control.
Tight Blood Pressure Management
Tight blood pressure control.
Phenylephrine
Phenylephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
Norepinephrine
Norepinephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
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
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
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
Beijing Shijitan Hospital, Capital Medical University
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Shanghai Ninth People's Hospital
Shanghai, , China
Shanghai Chest Hospital
Shanghai, , China
West China Hospital
Sichuan, , China
University of Thessaly
Larissa, , Greece
National Defense College
Tokyo, , Japan
Countries
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Other Identifiers
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HSC-MS-24-1026 (vasopressor)
Identifier Type: -
Identifier Source: org_study_id
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