Managing blood pressure during major surgery

Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications: The GUARDIAN Pilot Trial

This study tests whether closely managing blood pressure with specific medications during major surgery can help prevent serious heart problems and other complications compared to just resuming regular blood pressure medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT04789733 on ClinicalTrials.gov

What this trial studies

This trial investigates two approaches to blood pressure management in patients undergoing major noncardiac surgery. Participants will be randomized to receive either tight pressure management with norepinephrine or phenylephrine infusion, or routine management with prompt resumption of their chronic antihypertensive medications. The study aims to assess the impact of these strategies on major adverse cardiac events, delirium, and acute kidney injury. Patients will be closely monitored with arterial catheter transducers to ensure accurate blood pressure readings throughout the procedure.

Who should consider this trial

Good fit: Ideal candidates are patients aged 45 and older scheduled for major noncardiac surgery who are chronically taking antihypertensive medications and have specific risk factors.

Not a fit: Patients who are not undergoing major surgery or those without chronic hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes for patients undergoing major surgery by reducing the risk of serious complications related to blood pressure management.

How similar studies have performed: Previous studies have shown varying success with different blood pressure management strategies in surgical settings, but this specific approach is novel.

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.

Where this trial is running

Changchun, Jilin

• China Japan Union Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Roberta Johnson

Conditions General Surgery; Blood pressure; major adverse cardiac events; Delirium; Acute kidney injury