By InvitationPhase 4

The GUARDIAN Trial - Induction Agent Sub-Study

United States, China6,254 participantsStarted 2021-07-25

Plain-language 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.

Who can participate

Age range45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. At least 45 years old;
✓. Scheduled for major noncardiac surgery expected to last at least 2 hours;
✓. Having general anesthesia, neuraxial anesthesia, or the combination;
✓. Expected to require at least overnight hospitalization (planned ICU admission is acceptable);
✓. Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life);
✓. Expected to have direct intraoperative blood pressure monitoring with an arterial catheter;
✓. Cared for by clinicians willing to follow the GUARDIAN protocol;
✓. Subject to at least one of the following risk factors:

Exclusion criteria

✕. Are scheduled for carotid artery surgery;
✕. Are scheduled for intracranial surgery;
✕. Are scheduled for partial or complete nephrectomy;
✕. Are scheduled for pheochromocytoma surgery;
✕. Are scheduled for liver or kidney transplantation;
✕. Require preoperative intravenous vasoactive medications;
✕. Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
✕. Require beach-chair positioning;

What they're measuring

Number of Participants with a Composite of Major Perfusion-Related Complications

Timeframe: During the initial 30 days after major non-cardiac surgery

Trial details

NCT IDNCT04934683

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

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