Managing blood pressure during major surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates two approaches to managing blood pressure in patients undergoing major noncardiac surgery. Participants will be randomly assigned to either a tight pressure management strategy using norepinephrine or phenylephrine to maintain a mean arterial pressure of at least 85 mmHg, or to routine blood pressure management. The study aims to evaluate the effectiveness of these approaches in maintaining stable blood pressure during surgery. Patients will be monitored closely, and adjustments to medications and fluids will be made as necessary.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. At least 45 years old;
2. Scheduled for major noncardiac surgery expected to last at least 2 hours;
3. Having general anesthesia, neuraxial anesthesia, or the combination;
4. Expected to require at least overnight hospitalization (planned ICU admission is acceptable);
5. Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life);
6. Expected to have direct intraoperative blood pressure monitoring with an arterial catheter;
7. Cared for by clinicians willing to follow the GUARDIAN protocol;
8. Subject to at least one of the following risk factors:

   1. Age \>65 years;
   2. History of peripheral arterial disease;
   3. History of coronary artery disease;
   4. History of stroke or transient ischemic attack;
   5. Serum creatinine \>175 μmol/L (\>2.0 mg/dl) within 6 months;
   6. Diabetes requiring medication;
   7. Current smoking or 15 pack-year history of smoking tobacco;
   8. Scheduled for major vascular surgery;
   9. Body mass index ≥35 kg/m2;
   10. 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14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay), 19 ng/L (Siemens assay, \[Borges, unpublished\]), or 25% of the 99% percentile for other assays - all within 6 months;
   11. B-type natriuretic protein (BNP) \>80 ng/L or N-terminal B-type natriuretic protein (NTProBNP) \>200 ng/L within six months.

Exclusion Criteria:

1. Are scheduled for carotid artery surgery;
2. Are scheduled for intracranial surgery;
3. Are scheduled for partial or complete nephrectomy;
4. Are scheduled for pheochromocytoma surgery;
5. Are scheduled for liver or kidney transplantation;
6. Require preoperative intravenous vasoactive medications;
7. Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
8. Require beach-chair positioning;
9. Have a documented history of dementia;
10. Have language, vision, or hearing impairments that may compromise cognitive assessments;
11. Have contraindications to norepinephrine or phenylephrine per clinician judgement;
12. Have previously participated in the GUARDIAN trial.

Where it's running

• MetroHealth Medical Center
  Cleveland, Ohio, United States Recruiting
• The University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting
• Beijing Shijitan Hospital, Capital Medical University
  Beijing, China Recruiting
• Peking Union Medical College Hospital
  Beijing, China Recruiting
• Peking University First Hospital
  Beijing, China Recruiting
• West China University Hospital
  Chengdu, China Recruiting

Study contacts

• Principal investigator: Daniel I Sessler, MD — The University of Texas Health Science Center, Houston
• Study coordinator: Valerie L. Anderson, BS
• Email: Valerie.L.Anderson@uth.tmc.edu
• Phone: (713) 500-4383

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.