2025-08-23
notable
Recruiting→Enrolling by Invitation Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v6
Trial statusRecruiting→Enrolling by Invitation
PhasePhase 3→Phase 4
Primary completion date2025-12→2026-12-31
Completion date2026-07→2027-04-25
Start date2021-07-27→2021-07-25
Study sites1→11
Lead sponsorThe Cleveland Clinic→The University of Texas Health Science Center, Houston
InterventionsEtomidate (Drug), Propofol (Drug), Routine blood pressure control (Procedure), Tight blood pressure control (Procedure)→Etomidate Induction (Drug), Propofol Induction (Drug), Routine Blood Pressure Management (Procedure), Tight Blood Pressure Management…
Eligibility criteria-103 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 r troponin I equivalent, defined as ≥15 ng/L (Abbott assay),77 19 ng/L (Siemens assay, [Borges, unpublished]), or 25% of the 99% percenti [...]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 endpoints3 to 1 entries
Number of Participants with Postoperative Delirium
Major Adverse cardiac events
Cognition
Primary endpoints1 entry, revised
Number of Participants with a Composite of seriousMajor perfusionPerfusion-relatedRelated complicationsComplications
Study description-20 characters
Patients participatingParticipants in the underlying GUARDIAN trial (NCT04884802) will be rand [...] in intraoperative MAP ≥85 mmHg (tight pressure management).
Patients participatingParticipants in this sub-study will be additionally randomized to etomidate or propofol for induction of anesthesia.
Study title-9 characters
The GUARDIAN (NCT04884802)Trial - Induction Agent Sub-study, Etomidate vs PropofolStudy
2023-08-22
minor
Study Status, Study Description, Contacts/Locations, IPDSharing v3
Study description-180 characters
[...] zed to: 1) routine intraoperative blood pressure management and prompt resumption of chronic antihypertensive medications (routine pressure management); or 2) norepinephrine or phenylephrine 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).
Patients participating in this [...]
Study sitescontacts updated at 1 of 1 site
2021-07-27
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Study Design, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
PhaseNot applicable→Phase 3
Start dateestimated 2021-07→confirmed 2021-07-27
Study sites0→1