GUARDIAN (NCT04884802) Sub-study, Etomidate vs Propofol

Major Surgery Clinical Trial

Official title:

GUARDIAN (NCT04884802) Sub-study Comparing Etomidate and Propofol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934683
• Other study ID #: GUARDIAN INDUCTION AGENT
• Status: Recruiting
• Phase: Phase 3
• Start date: July 27, 2021
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: The Cleveland Clinic
• Contact: Fabio Rodriquez Patarroyo, MD
• Phone: 216) 444-9674?
• Email: Rodrigf3[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Some patients participating in the underlying GUARDIAN trial (NCT04884802) will be additionally randomized to etomidate vs propofol for anesthetic induction.

Description:

Patients participating in the underlying GUARDIAN trial (NCT04884802) will be randomized to: 1) routine intraoperative blood pressure management (routine pressure management); or 2) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management). Patients participating in this sub-study will be additionally randomized to etomidate or propofol for induction of anesthesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6254
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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);

• Chronically taking at least one anti-hypertensive medication;

• 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 surgery;

• History of coronary artery disease;

• History of stroke or transient ischemic attack;

• Serum creatinine >175 µmol/L (>2.0 mg/dl);

• 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),77 19 ng/L (Siemens assay, [Borges, unpublished]), or 25% of the 99% percentile for other assays;

• B-type natriuretic protein (BNP) >80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) >200 ng/L.78,79

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 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 end-stage renal disease requiring dialysis or estimated glomerular filtration rate (eGFR) <30 ml/min;

• 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 this trial.

Related Conditions & MeSH terms

• Major Surgery

Intervention

Procedure:
• Routine blood pressure control
Routine blood pressure control.
• Tight blood pressure control
Tight blood pressure control.

Drug:
• Etomidate
Anesthetic induction with etomidate.
• Propofol
Anesthetic induction with propofol.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICU admission	Admission.	30 days.
Other	Hospital Readmission	Readmission.	30 days.
Other	Atrial Fibrillation	Atrial Fibrillation.	30 days.
Primary	Composite of serious perfusion-related complications	Composite of serious perfusion-related complications. Specifically, we will consider a collapsed (one or more) composite of myocardial injury after non-cardiac surgery (MINS), non-fatal cardiac arrest, stroke, Stage 2-3 acute kidney injury, sepsis, and all-cause mortality within 30 days of surgery.	30 days after surgery
Secondary	Postoperative Delirium	Delirium, defined by abnormal 3D CAM or CAM ICU (in ventilated patients) assessed twice daily during the initial four postoperative days.	Initial four postoperative days
Secondary	Major Adverse cardiac events	Myocardial infarction, non-fatal cardiac arrest, stroke, and all-cause mortality.	1 year
Secondary	Cognition	T-MOCA	1 Year