By InvitationPhase 4

The GUARDIAN Trial - Induction Agent Sub-Study

United States, China, Greece6,254 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 range

45 Years

Sex

ALL

See this in plain English?

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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