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Status:

RECRUITING

The GUARDIAN Trial

Lead Sponsor:

The University of Texas Health Science Center, Houston

Conditions:

Blood Pressure

Eligibility:

All Genders

45+ years

Phase:

NA

Brief Summary

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, str...

Detailed Description

Qualifying patients will be randomized 1:1, with random-sized blocks, stratified by site. The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (t...

Eligibility Criteria

Inclusion

  • At least 45 years old;
  • Scheduled for major noncardiac surgery expected to last at least 2 hours;
  • Having general anesthesia, neuraxial anesthesia, or the combination;
  • Expected to require at least overnight hospitalization (planned ICU admission is acceptable);
  • Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life);
  • Expected to have direct intraoperative blood pressure monitoring with an arterial catheter;
  • Cared for by clinicians willing to follow the GUARDIAN protocol;
  • Subject to at least one of the following risk factors:
  • Age \>65 years;
  • History of peripheral arterial disease;
  • History of coronary artery disease;
  • History of stroke or transient ischemic attack;
  • Serum creatinine \>175 μmol/L (\>2.0 mg/dl) within 6 months;
  • Diabetes requiring medication;
  • Current smoking or 15 pack-year history of smoking tobacco;
  • Scheduled for major vascular surgery;
  • Body mass index ≥35 kg/m2;
  • Preoperative high-sensitivity troponin T \>14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay), 19 ng/L (Siemens assay, \[Borges, unpublished\]), or 25% of the 99% percentile for other assays - all within 6 months;
  • B-type natriuretic protein (BNP) \>80 ng/L or N-terminal B-type natriuretic protein (NTProBNP) \>200 ng/L within six months.

Exclusion

  • Are scheduled for carotid artery surgery;
  • Are scheduled for intracranial surgery;
  • Are scheduled for partial or complete nephrectomy;
  • Are scheduled for pheochromocytoma surgery;
  • Are scheduled for liver or kidney transplantation;
  • Require preoperative intravenous vasoactive medications;
  • Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
  • Require beach-chair positioning;
  • Have a documented history of dementia;
  • Have language, vision, or hearing impairments that may compromise cognitive assessments;
  • Have contraindications to norepinephrine or phenylephrine per clinician judgement;
  • Have previously participated in the GUARDIAN trial.

Key Trial Info

Start Date :

July 25 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 25 2027

Estimated Enrollment :

6254 Patients enrolled

Trial Details

Trial ID

NCT04884802

Start Date

July 25 2021

End Date

April 25 2027

Last Update

August 29 2025

Active Locations (20)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (20 locations)

1

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

2

Wake Forest University

Wake Forest, North Carolina, United States, 27106

3

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

4

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States, 44111