NCT04934683

The GUARDIAN Trial - Induction Agent Sub-Study

Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications: The GUARDIAN Trial (Induction Agent Sub-Study Comparing Etomidate and Propofol)

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6,254 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants in the underlying GUARDIAN trial (NCT04884802) will be randomized to: 1) routine intraoperative blood pressure management (routine pressure management); or 2) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management). Participants in this sub-study will be additionally randomized to etomidate or propofol for induction of anesthesia.

Conditions

• Major Surgery

Interventions

Type	Name	Description
PROCEDURE	Routine Blood Pressure Management	Routine blood pressure control.
PROCEDURE	Tight Blood Pressure Management	Tight blood pressure control.
DRUG	Etomidate Induction	Anesthetic induction with etomidate.
DRUG	Propofol Induction	Anesthetic induction with propofol.

Timeline

• Start date: 2021-07-25
• Primary completion: 2026-12-31
• Completion: 2027-04-25
• First posted: 2021-06-22
• Last updated: 2025-08-29

Locations

11 sites across 4 countries: United States, China, Greece, Japan

Regulatory

• FDA-regulated drug study