Enrolling by invitation
Phase 4
The GUARDIAN Trial - Induction Agent Sub-Study
Condition(s) studied
Major Surgery
Investigational drug(s) / intervention(s)
Routine Blood Pressure ManagementTight Blood Pressure ManagementEtomidate InductionPropofol Induction
Routine Blood Pressure Management: Routine blood pressure control.
Tight Blood Pressure Management: Tight blood pressure control.
Etomidate Induction: Anesthetic induction with etomidate.
Propofol Induction: Anesthetic induction with propofol.
Study summary
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.
Eligibility
Inclusion Criteria:
1. At least 45 years old;
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14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay), 19 ng/L (Siemens assay, \[Borges, unpublished\]), or 25% of the 99% percentile for other assays - all within 6 months;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:
1. Are scheduled for carotid artery surgery;
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.
Primary outcome measure(s)
- Number of Participants with a Composite of Major Perfusion-Related Complications — During the initial 30 days after major non-cardiac surgery
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.
Trial sites (11)
| Facility | City | Region | Status |
| University of Nebraska Medical Center |
Omaha |
Nebraska |
|
| MetroHealth Medical Center |
Cleveland |
Ohio |
|
| Cleveland Clinic Fairview Hospital |
Cleveland |
Ohio |
|
| Cleveland Clinic Main Campus |
Cleveland |
Ohio |
|
| Shanghai Ninth People's Hospital |
Shanghai |
Shanghai Municipality |
|
| Beijing Shijitan Hospital, Capital Medical University |
Beijing |
China |
|
| Peking Union Medical College Hospital |
Beijing |
China |
|
| Shanghai Chest Hospital |
Shanghai |
China |
|
| West China Hospital |
Sichuan |
China |
|
| University of Thessaly |
Larissa |
Greece |
|
| National Defense College |
Tokyo |
Japan |
|
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