| NCT ID | NCT04884802 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Blood Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,254 participants |
| Start Date | 2021-07-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6,254 participants in total. It began in 2021-07-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
An international randomized trial to test the primary hypothesis that perioperative tight blood pressure management reduces a composite of major perfusion-related complications (myocardial injury, stroke, non-fatal cardiac arrest, Stage 2-3 acute kidney injury, deep or organ-space infection, sepsis, and death) in the 30 days after major non-cardiac surgery. The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management (routine pressure management).
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.
Contact & Investigator
Daniel I Sessler, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT04884802 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Blood Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04884802 currently recruiting?
Yes, NCT04884802 is actively recruiting participants. Contact the research team at Valerie.L.Anderson@uth.tmc.edu for enrollment information.
Where is the NCT04884802 trial being conducted?
This trial is being conducted at Omaha, United States, Wake Forest, United States, Cleveland, United States, Cleveland, United States and 11 additional locations.
Who is sponsoring the NCT04884802 clinical trial?
NCT04884802 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Daniel I Sessler, MD at The University of Texas Health Science Center, Houston. The trial plans to enroll 6,254 participants.