The GUARDIAN Trial

Description

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).

Conditions

Blood Pressure

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Study Overview

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Study Details

Study overview

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).

Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications.

The GUARDIAN Trial

Condition
Blood Pressure
Intervention / Treatment

-

Contacts and Locations

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

Wake Forest

Wake Forest University, Wake Forest, North Carolina, United States, 27106

Cleveland

MetroHealth Medical Center, Cleveland, Ohio, United States, 44109

Cleveland

Cleveland Clinic Fairview Hospital, Cleveland, Ohio, United States, 44111

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * ≥45 years old
  • * Scheduled for major noncardiac surgery expected to last at least 2 hours;
  • * Having general endotracheal, neuraxial anesthesia, or the combination;
  • * Expected to require at least overnight hospitalization;
  • * Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life);
  • * Chronically taking at least one anti-hypertensive medication;
  • * Expected to have direct 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:
  • * 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);
  • * 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),73 19 ng/L (Siemens assay, \[Borges, unpublished\]), or 50% of the 99% percentile for other assays; B-type natriuretic protein (BNP) \>80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) \>200 ng/L
  • * 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.

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Daniel I Sessler, MD, STUDY_CHAIR, The Cleveland Clinic

Study Record Dates

2027-04-25