GUARDIAN Trial of Tight Versus Routine Blood Pressure Control During Major Non-Cardiac Surgery to Prevent Serious Cardiovascular and Kidney Complications

What this Trial Is About

Researchers are investigating whether tightly controlling blood pressure during major non-cardiac surgery can reduce serious complications related to poor blood flow, such as heart injury, stroke, kidney damage, infections, sepsis, and death within 30 days after surgery. This international randomized trial compares two approaches to managing blood pressure during surgery to see which might better prevent these serious events. The study involves adults aged 45 and older undergoing major surgeries expected to last at least two hours and requiring general or neuraxial anesthesia. Participants are randomly assigned to one of two groups tight blood pressure management or routine blood pressure management. In the tight management group, medications norepinephrine or phenylephrine are infused to keep the mean arterial pressure MAP at or above 85 mmHg during surgery, and certain blood pressure medications are withheld on the morning of surgery. In the routine management group, blood pressure is managed as usual, with blood pressure medications allowed if the anesthesiologist agrees. Other aspects of anesthesia and postoperative care are handled per standard procedures and clinician judgment in both groups. During the study, participants will be monitored closely through blood pressure measurements and clinical assessments. Researchers will track the occurrence of major perfusion-related complications in the first 30 days after surgery as the primary outcome. They will also assess postoperative delirium during the first four days after surgery. The study includes detailed anesthesia management and hospitalization, aiming to capture important health outcomes while ensuring patient safety. Participation lasts through the initial postoperative period with ongoing monitoring as needed.

The GUARDIAN Trial