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The GUARDIAN Trial
NCT04884802 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- PROCEDURE Tight blood pressure management
- PROCEDURE Routine blood pressure management
Study Locations (20)
Other
- Beijing Shijitan Hospital, Capital Medical University — Beijing
- Peking Union Medical College Hospital — Beijing
- Peking University First Hospital — Beijing
- West China University Hospital — Chengdu
- Prince of Wales Hospital, Chinese University of Hong Kong, Shatin — Hong Kong
- Renji Hospital, Shanghai Jiaotong University School of Medicine — Shanghai
- Shanghai Chest Hospital — Shanghai
- Shanghai Ninth People's Hospital — Shanghai
- The Affiliated Lianyungang Hospital of Xuzhou Medical University — Xuzhou
- University of Thessaly — Larissa
- IRCCS Regina Elena National Cancer Institute — Rome
- National Defense Medical College — Tokyo
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital — Bakırköy
- Konya City Hospital — Konya
Ohio
- MetroHealth Medical Center — Cleveland
- Cleveland Clinic Fairview Hospital — Cleveland
- Cleveland Clinic Main Campus — Cleveland
Nebraska
- University of Nebraska Medical Center — Omaha
North Carolina
- Wake Forest University — Wake Forest
Texas
- The University of Texas Health Science Center at Houston — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,254 participants |
| Start Date | 2021-07-25 |
| Est. Completion | 2027-04-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04884802
The ClinicalTrials.gov registry entry for NCT04884802 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6,254 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 811 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Blood Pressure appearing as the primary indexed condition, and to 2 interventions — of which Tight blood pressure management is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04884802 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, Ohio, Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04884802 about?
NCT04884802 is a clinical study titled "The GUARDIAN Trial". 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,...
What is the current status of trial NCT04884802?
This trial is currently recruiting. It is a NA study. The enrollment target is 6,254 participants. The study started on 2021-07-25. Estimated completion is 2027-04-25.
What conditions does trial NCT04884802 study?
This clinical trial studies the following conditions: Blood Pressure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04884802?
The interventions under investigation include: Tight blood pressure management (PROCEDURE), Routine blood pressure management (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04884802?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 811 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04884802 being conducted?
This trial has 20 study locations across Nebraska, North Carolina, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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