Overview

GUARDIAN (NCT04884802) Sub-study, Phenylephrine v. Norepinephrine

Status:
Enrolling by invitation
Trial end date:
2025-07-01
Target enrollment:
0
Participant gender:
All
Summary
Some patients participating in the underlying GUARDIAN trial (NCT04884802) will be additionally randomized to norepinephrine or phenylephrine infusion to maintain the designated target intraoperative mean arterial pressure.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Cleveland Clinic
Treatments:
Norepinephrine
Oxymetazoline
Phenylephrine
Criteria
Inclusion Criteria:

- 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);

- Chronically taking at least one anti-hypertensive medication;

- 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 surgery;

- 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≥15 ng/L (Abbott assay),77 19 ng/L (Siemens assay, [Borges, unpublished]), or 25% of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.78,79

Exclusion Criteria:

- 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.