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The GUARDIAN Trial - Vasopressor Sub-Study for Blood Pressure Management During Surgery

This study, called the GUARDIAN Trial - Vasopressor Sub-Study, is looking at the best way to manage blood pressure during major non-heart surgery. Researchers are comparing two approaches: routine blood pressure management versus tight blood pressure management. For some participants, they will also compare two medications, phenylephrine and norepinephrine, to maintain a specific blood pressure during surgery. The main goal is to see if one approach leads to fewer major complications related to blood flow (perfusion) within 30 days after surgery. You may be able to join if you are at least 45 years old and scheduled for major non-heart surgery expected to last at least 2 hours and require an overnight hospital stay. The study status is currently unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is a sub-study of a larger trial and plans to enroll 6254 participants.
What's involved
Participants will undergo either routine or tight blood pressure management during surgery. Some will also receive infusions of phenylephrine or norepinephrine during surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 30 days after major non-cardiac surgery to check for complications.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04934748

The GUARDIAN Trial - Vasopressor Sub-Study

Enrolling by Invitation
PHASE4Ages 45+InterventionalPrevention
The University of Texas Health Science Center, Houston
~6,254 participants
Updated 2025-08-29 on ClinicalTrials.gov
What's tested:Routine Blood Pressure ManagementTight Blood Pressure ManagementPhenylephrineNorepinephrine

At a glance

Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with a Composite of Major Perfusion-Related Complications
Measured over During the initial 30 days after major non-cardiac surgery

Conditions

Blood Pressure

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NCT04934748

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beijing Shijitan Hospital, Capital Medical University

    Beijing, Chinano site contact published

  • Cleveland Clinic Fairview Hospital

    Cleveland, Ohiono site contact published

  • Cleveland Clinic Main Campus

    Cleveland, Ohiono site contact published

  • MetroHealth Medical Center

    Cleveland, Ohiono site contact published

  • National Defense College

    Tokyo, Japanno site contact published

  • Peking Union Medical College Hospital

    Beijing, Chinano site contact published

  • Shanghai Chest Hospital

    Shanghai, Chinano site contact published

  • Shanghai Ninth People's Hospital

    Shanghai, Chinano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Number of Participants with a Composite of Major Perfusion-Related ComplicationsDuring the initial 30 days after major non-cardiac surgery

    The primary outcome is 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.