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The GUARDIAN Trial

NCT04884802 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6254

Last updated 2025-08-29

No results posted yet for this study

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).

Conditions

  • Blood Pressure

Interventions

PROCEDURE

Tight blood pressure management

Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg.

PROCEDURE

Routine blood pressure management

ACEIs, ARBs, and/or calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist. Intraoperative blood pressure will be managed per clinical routine.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Daniel I Sessler, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-25
Primary Completion
2026-12-31
Completion
2027-04-25

Countries

  • United States
  • China
  • Greece
  • Italy
  • Japan
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04884802 on ClinicalTrials.gov