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ENROLLING BY INVITATION
NCT04934748
PHASE4

The GUARDIAN Trial - Vasopressor Sub-Study

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6254

Start Date

2021-07-25

Completion Date

2027-04-25

Last Updated

2025-08-29

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (11)

University of Nebraska Medical Center

Omaha, Nebraska, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Beijing Shijitan Hospital, Capital Medical University

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Shanghai Ninth People's Hospital

Shanghai, China

Shanghai Chest Hospital

Shanghai, China

West China Hospital

Sichuan, China

University of Thessaly

Larissa, Greece

National Defense College

Tokyo, Japan