NCT04934748

The GUARDIAN Trial - Vasopressor Sub-Study

Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications: The GUARDIAN Trial (Vasopressor Sub-study Comparing Phenylephrine and Norepinephrine)

• 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 norepinephrine or phenylephrine infusion to maintain the designated target intraoperative mean arterial pressure.

Detailed description

Participants in the underlying GUARDIAN trial (NCT04884802) will be randomized to: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management (routine pressure management). Participants in this sub-study will be additionally randomized to norepinephrine or phenylephrine infusion to maintain the designated target intraoperative mean arterial pressure.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
PROCEDURE	Routine Blood Pressure Management	Routine blood pressure control.
PROCEDURE	Tight Blood Pressure Management	Tight blood pressure control.
DRUG	Phenylephrine	Phenylephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
DRUG	Norepinephrine	Norepinephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.

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