Status:
RECRUITING
The GUARDIAN Pilot Trial
Lead Sponsor:
The Cleveland Clinic
Conditions:
General Surgery
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward MAP ≥80 mmHg ...
Detailed Description
Consenting patients who take either angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or calcium channel blockers will be asked not to take the medications on the...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04789733
Start Date
April 27 2021
End Date
March 30 2026
Last Update
August 27 2025
Active Locations (1)
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1
China Japan Union Hospital of Jilin University
Changchun, Jilin, China