The GUARDIAN Trial
Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications: The GUARDIAN Trial
The University of Texas Health Science Center, Houston
6,254 participants
Jul 25, 2021
INTERVENTIONAL
Conditions
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, 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).
Eligibility
Inclusion Criteria19
- 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14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay), 19 ng/L (Siemens assay, \[Borges, unpublished\]), or 25% of the 99% percentile for other assays - all within 6 months;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 Criteria12
- 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.
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Interventions
Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg.
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.
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT04884802