The GUARDIAN Trial - Induction Agent Sub-Study

Conditions

• Major Surgery

Eligibility Criteria

Sex

ALL

Age

45 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Routine Blood Pressure Management — PROCEDURE
  Routine blood pressure control.
• Tight Blood Pressure Management — PROCEDURE
  Tight blood pressure control.
• Etomidate Induction — DRUG
  Anesthetic induction with etomidate.
• Propofol Induction — DRUG
  Anesthetic induction with propofol.

Study Details

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.

Key Dates

Start date

Jul 25, 2021

Status verified

Jul 2025

Primary completion

Dec 31, 2026

Completion

Apr 25, 2027

Study Design

Enrollment

6,254 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Arms

• Active Comparator: Routine Blood Pressure Management and Etomidate Induction
  Etomidate will be used as the anesthetic induction agent.
• Active Comparator: Routine Blood Pressure Management and Propofol Induction
  Propofol will be used as the anesthetic induction agent.
• Active Comparator: Tight Blood Pressure Management and Etomidate Induction
  Etomidate will be used as the anesthetic induction agent.
• Active Comparator: Tight Blood Pressure Management and Propofol Induction
  Propofol will be used as the anesthetic induction agent.

Primary Outcome Measure

Number of Participants with a Composite of Major Perfusion-Related Complications [ Time Frame: During the initial 30 days after major non-cardiac surgery ]

Locations (4)

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