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The GUARDIAN Trial - Vasopressor Sub-Study

StatusEnrolling by Invitation
PhasePhase 4
Started2021-07-25
View on ClinicalTrials.gov ↗

Amendment history

2025-08-23
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v5
Primary completion date2027-12→2026-12-31
Completion date2028-07→2027-04-25
Start date2021-07-15→2021-07-25
Study sites1→11
Lead sponsorThe Cleveland Clinic→The University of Texas Health Science Center, Houston
InterventionsNorepinephrine (Drug), Norepinephrine (Drug), Phenylephrine (Drug), Phenylephrine (Drug)→Norepinephrine (Drug), Phenylephrine (Drug), Routine Blood Pressure Management (Procedure), Tight Blood Pressure Management (Procedure)
Eligibility criteria-14 characters
[...] severe systemic disease that is a constant threat to life); Chronically taking at least one anti-hypertensive medication; Expected to have direct intraoperative blood pressure monito [...] risk factors: Age >65 years; History of peripheral arterial surgerydisease; History of coronary artery disease; History of stroke or transient ischemic attack; Serum creatinine >175 µmolμmol/L (>2.0 mg/dl) within 6 months; Diabetes requiring medication; Current smoking or 15 pack- [...] r troponin I equivalent, defined as ≥15 ng/L (Abbott assay),77 19 ng/L (Siemens assay, [Borges, unpublished]), or 25% of the 99% percenti [...] [...]
Secondary endpoints-22 characters
Postoperative delirium
Primary endpoints1 entry, revised
Number of Participants with a Composite of majorMajor perfusionPerfusion-relatedRelated complicationsComplications
Study description-20 characters
Patients participatingParticipants in the underlying GUARDIAN trial (NCT04884802) will be rand [...] ve blood pressure management (routine pressure management). Patients participatingParticipants in this sub-study will be additionally randomized to norepi [...]
Study title-23 characters
The GUARDIAN (NCT04884802)Trial - Vasopressor Sub-study, Phenylephrine v. NorepinephrineStudy
2024-09-11
Study Status v4
Primary completion date2024-12→2027-12
Completion date2025-07→2028-07
2023-08-28
Study Status, Study Description v3
Study description-180 characters
[...] enylephrine infusion to maintain intraoperative MAP ≥85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward systolic pressure of at least 110 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management and prompt resumption of chronic antihypertensive medications (routine pressure management). Patients participating in thi [...]
2022-09-07
Study Status v2
Re-verified, no change to tracked fields
2021-08-17
Not Yet Recruiting→Enrolling by Invitation Study Status, Oversight, Study Design, Contacts/Locations v1
Trial statusNot Yet Recruiting→Enrolling by Invitation
PhaseNot applicable→Phase 4
Start dateestimated 2021-07→confirmed 2021-07-15
Study sites0→1
2021-06-15
Original filing
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.
Trial Details
NCT Number NCT04934748
Lead Sponsor The University of Texas Health Science Center, Houston
Conditions Blood Pressure
Enrollment 6,254 participants
Start Date 2021-07-25
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-04-25 (estimated)
Updated on ClinicalTrials.gov 2025-08-29