The GUARDIAN Pilot Trial

Launched by THE CLEVELAND CLINIC · Mar 8, 2021

Keywords

ClinConnect Summary

The GUARDIAN Pilot Trial is a research study looking at how to best manage blood pressure during major surgeries. The trial compares two approaches: one group of patients will receive tight control of their blood pressure using medications (norepinephrine or phenylephrine) to keep it above a target level, while the other group will have standard blood pressure management with their usual medications resumed quickly after surgery. The goal is to see which method helps patients better during and after their surgery.

To join this trial, participants need to be at least 45 years old, scheduled for major non-heart surgery that lasts at least two hours, and must be taking blood pressure medications regularly. They should also have certain health conditions that put them at risk, such as a history of heart disease or diabetes. Those who join can expect careful monitoring of their blood pressure and support from their healthcare team throughout the study. It's important to note that some patients might not be eligible due to specific health issues or types of surgery being scheduled.

Gender

ALL

Eligibility criteria

• Inclusion 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 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;
• • B-type natriuretic protein (BNP) \>80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) \>100 ng/L
• 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 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 end-stage renal disease requiring dialysis or estimated glomerular filtration rate (eGFR) \<30 ml/min;
• • 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 this trial.