Managing blood pressure during major surgery

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

This study tests whether a tighter blood pressure management method during major surgery can help patients keep their blood pressure stable compared to regular management.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 6254 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Locations: 20 sites (Omaha, Nebraska and 19 other locations)
• Trial ID: NCT04884802 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 and older scheduled for major noncardiac surgery with a history of hypertension and certain cardiovascular risk factors.

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

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients undergoing major surgery.

How similar studies have performed: Previous studies have shown that tight blood pressure management can improve surgical outcomes, suggesting this approach may be beneficial.

Eligibility criteria

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 this trial is running

Omaha, Nebraska and 19 other locations

• University of Nebraska Medical Center — Omaha, Nebraska, United States (Completed)
• Wake Forest University — Wake Forest, North Carolina, United States (Completed)
• MetroHealth Medical Center — Cleveland, Ohio, United States (Recruiting)
• Cleveland Clinic Fairview Hospital — Cleveland, Ohio, United States (Completed)
• Cleveland Clinic Main Campus — Cleveland, Ohio, United States (Completed)
• 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)
• Prince of Wales Hospital, Chinese University of Hong Kong, Shatin — Hong Kong, China (Recruiting)
• Renji Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (Recruiting)
• Shanghai Chest Hospital — Shanghai, China (Recruiting)
• Shanghai Ninth People's Hospital — Shanghai, China (Recruiting)
• The Affiliated Lianyungang Hospital of Xuzhou Medical University — Xuzhou, China (Recruiting)
• University of Thessaly — Larissa, Greece (Completed)
• IRCCS Regina Elena National Cancer Institute — Rome, Italy (Recruiting)
• National Defense Medical College — Tokyo, Japan (Recruiting)
• Bakirkoy Dr. Sadi Konuk Research and Training Hospital — Bakırköy, Turkey (Türkiye) (Recruiting)
• Konya City Hospital — Konya, Turkey (Türkiye) (Recruiting)

Study contacts

• Principal investigator: Daniel I Sessler, MD — The University of Texas Health Science Center, Houston
• Study coordinator: Valerie L. Anderson, BS

Conditions Blood Pressure