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Enrolling by invitation Phase 4

The GUARDIAN Trial - Induction Agent Sub-Study

NCT04934683 · tracked via the Priya Life Science Japan tracker
Phase
Phase 4
Started
2021-07-25
Last updated
2025-08-29

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

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
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14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay), 19 ng/L (Siemens assay, \[Borges, unpublished\]), or 25% of the 99% percentile for other assays - all within 6 months; 11.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)

FacilityCityRegionStatus
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

More The University of Texas Health Science Center, Houston trials in Japan

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04934683 on ClinicalTrials.gov ↗ ← All trials in Japan