The GUARDIAN Trial

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT04884802
Status
Recruiting
Apply to this trial

Conditions

  • Blood Pressure

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tight blood pressure management — PROCEDURE
    Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg.
  • Routine blood pressure management — PROCEDURE
    ACEIs, ARBs, and/or calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist. Intraoperative blood pressure will be managed per clinical routine.

Study Details

An international randomized trial to test the primary hypothesis that perioperative tight blood pressure management reduces a composite of major perfusion-related complications (myocardial injury, stroke, non-fatal cardiac arrest, Stage 2-3 acute kidney injury, deep or organ-space infection, sepsis, and death) in the 30 days after major non-cardiac surgery. The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management (routine pressure management).

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
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Tight blood pressure management
    In patients assigned to tight blood pressure control, angiotensin converting enzyme inhibitors and angiotensin receptor blockers will not be given the morning of surgery. Other chronic antihypertensives will only be given as necessary to treat hypertension. Norepinephrine or phenylephrine infusion will be infused at a rate sufficient to maintain intraoperative MAP ≥ 85 mmHg.
  • Other: Routine blood pressure management
    ACEIs, ARBs, and/or calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist. Intraoperative blood pressure will be managed per clinical routine.

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 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198-
Wake Forest UniversityWake ForestNorth Carolina27106-
Cleveland Clinic Fairview HospitalClevelandOhio44111-
Cleveland Clinic Main CampusClevelandOhio44195-
MetroHealth Medical CenterClevelandOhio44109
Luis Tollinche, MD
[email protected]
The University of Texas Health Science Center at HoustonHoustonTexas77030
Valerie Anderson, BS
[email protected]
713-500-4383

Find similar trials in Omaha, NE

By research site
University of Nebraska Medical Center· Omaha, NEWake Forest University· Wake Forest, NCCleveland Clinic Fairview Hospital· Cleveland, OHCleveland Clinic Main Campus· Cleveland, OHMetroHealth Medical Center· Cleveland, OHThe University of Texas Health Science Center at Houston· Houston, TX

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