The GUARDIAN Trial - Vasopressor Sub-Study

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT04934748
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Blood Pressure

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.
  • Phenylephrine — DRUG
    Phenylephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
  • Norepinephrine — DRUG
    Norepinephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.

Study Details

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.

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 with Phenylephrine
    Routine blood pressure control with phenylephrine infusion at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
  • Active Comparator: Routine Blood Pressure Management with Norepinephrine
    Routine blood pressure control with norepinephrine infusion at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
  • Active Comparator: Tight Blood Pressure Management with Phenylephrine
    TIiht blood pressure control with phenylephrine infusion at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial
  • Active Comparator: Tight Blood Pressure Management with Norepinephrine
    Tight blood pressure control with norepinephrine infusion at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.

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)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198-
Cleveland Clinic Fairview HospitalClevelandOhio44111-
Cleveland Clinic Main CampusClevelandOhio44195-
MetroHealth Medical CenterClevelandOhio44109-

Find similar trials in Omaha, NE

By research site
University of Nebraska Medical Center· Omaha, NECleveland Clinic Fairview Hospital· Cleveland, OHCleveland Clinic Main Campus· Cleveland, OHMetroHealth Medical Center· Cleveland, OH

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