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The GUARDIAN Trial - Vasopressor Sub-Study

NCT04934748 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6254

Last updated 2025-08-29

No results posted yet for this study

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.

Conditions

  • Blood Pressure

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Daniel I Sessler, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-25
Primary Completion
2026-12-31
Completion
2027-04-25
FDA Drug
Yes

Countries

  • United States
  • China
  • Greece
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04934748 on ClinicalTrials.gov