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Enrolling by invitation NCT04934748

The GUARDIAN Trial - Vasopressor Sub-Study

Phase IV Interventional Blood Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Routine Blood Pressure Management, Tight Blood Pressure Management, Phenylephrine, Norepinephrine.
Who it may be relevant to
Registry conditions: Blood Pressure. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China, Greece, Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications: The GUARDIAN Trial (Vasopressor Sub-study Comparing Phenylephrine and Norepinephrine)

Overview

This is a sub-study of the overall GUARDIAN trial (NCT04884802) in which some GUARDIAN trial participants will be additionally randomized to norepinephrine or phenylephrine infusion to maintain the designated target intraoperative mean arterial pressure.

Detailed description

Participants in the underlying GUARDIAN trial (NCT04884802) will be randomized to: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management (routine pressure management). Participants in this sub-study will be additionally randomized to norepinephrine or phenylephrine infusion to maintain the designated target intraoperative mean arterial pressure.

Interventions

  • Procedure Routine Blood Pressure Management
    Routine blood pressure control.
  • Procedure Tight Blood Pressure Management
    Tight blood pressure control.
  • Drug Phenylephrine
    Phenylephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
  • Drug Norepinephrine
    Norepinephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.

Primary outcome measures

  • Number of Participants with a Composite of Major Perfusion-Related Complications [Time frame: During the initial 30 days after major non-cardiac surgery]

Eligibility criteria

Inclusion criteria

  • At least 45 years old;
  • Scheduled for major noncardiac surgery expected to last at least 2 hours;
  • Having general anesthesia, neuraxial anesthesia, or the combination;
  • Expected to require at least overnight hospitalization (planned ICU admission is acceptable);
  • Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life);
  • Expected to have direct intraoperative blood pressure monitoring with an arterial catheter;
  • Cared for by clinicians willing to follow the GUARDIAN protocol;
  • Subject to at least one of the following risk factors:
  • Age >65 years;
  • History of peripheral arterial disease;
  • History of coronary artery disease;
  • History of stroke or transient ischemic attack;
  • Serum creatinine >175 μmol/L (>2.0 mg/dl) within 6 months;
  • Diabetes requiring medication;
  • Current smoking or 15 pack-year history of smoking tobacco;
  • Scheduled for major vascular surgery;
  • Body mass index ≥35 kg/m2;
  • 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;
  • B-type natriuretic protein (BNP) >80 ng/L or N-terminal B-type natriuretic protein (NTProBNP) >200 ng/L within six months.

Exclusion criteria

  • Are scheduled for carotid artery surgery;
  • Are scheduled for intracranial surgery;
  • Are scheduled for partial or complete nephrectomy;
  • Are scheduled for pheochromocytoma surgery;
  • Are scheduled for liver or kidney transplantation;
  • Require preoperative intravenous vasoactive medications;
  • Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
  • Require beach-chair positioning;
  • Have a documented history of dementia;
  • Have language, vision, or hearing impairments that may compromise cognitive assessments;
  • Have contraindications to norepinephrine or phenylephrine per clinician judgement;
  • Have previously participated in the GUARDIAN trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 5 centers
  • Beijing Shijitan Hospital, Capital Medical University — Beijing
  • Peking Union Medical College Hospital — Beijing
  • Shanghai Ninth People's Hospital — Shanghai
  • Shanghai Chest Hospital — Shanghai
  • West China Hospital — Sichuan
United States · 4 centers
  • University of Nebraska Medical Center — Omaha
  • MetroHealth Medical Center — Cleveland
  • Cleveland Clinic Fairview Hospital — Cleveland
  • Cleveland Clinic Main Campus — Cleveland
Greece · 1 center
  • University of Thessaly — Larissa
Japan · 1 center
  • National Defense College — Tokyo

Identifiers

NCT: NCT04934748 · HSC-MS-24-1026 (vasopressor)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗