Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04884802 |
Other study ID # |
21-175 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 25, 2021 |
Est. completion date |
April 25, 2025 |
Study information
Verified date |
August 2023 |
Source |
The Cleveland Clinic |
Contact |
Fabio Rodriguez Patarroyo, MD |
Phone |
?(216) 444-9674? |
Email |
Rodrigf3[@]ccf.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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).
Description:
Qualifying patients will be randomized 1:1, with random-sized blocks, stratified by site.
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).
Tight pressure management: In patients assigned to tight pressure management, angiotensin
converting enzyme inhibitors and angiotensin receptor blockers will not be given the morning
of surgery. Other chronic antihypertensives will only be given as necessary to treat
hypertension. A norepinephrine or phenylephrine infusion (in the preferred local
concentration) will be prepared, connected to an intravenous catheter, and activated at a low
rate. Norepinephrine can be safely given through a central catheter or peripherally. General
anesthesia will be induced with propofol or etomidate which will be given in repeated small
boluses or target-controlled infusion in an effort to keep mean arterial pressure ≥85 mmHg.
Clinicians will be encouraged to use etomidate when rapid-sequence inductions are required.
Simultaneously, the vasopressor infusion will be adjusted with the same goal. Anesthetic
dose, fluid administration, and vasopressor administration will be adjusted with the goal of
maintaining the individual designated baseline mean arterial pressure. Invasive or
non-invasive advanced hemodynamic monitoring is not required, but should be used when
practical. Clinicians should use available information to optimize vascular volume,
afterload, and inotropy.
Routine pressure management: In patients assigned to routine pressure management, ACEIs,
ARBs, and/or calcium channel blockers can be given the morning of surgery if deemed
appropriate by the attending anesthesiologist. General anesthesia will be induced and
maintained per routine. Blood pressure will not be deliberately reduced, but per routine
clinicians will presumably not intervene until MAP is <60 mmHg - although they are free to.
In both groups, other aspects of anesthetic management will be at the discretion of the
responsible anesthesiologist, including the types and volumes of various fluids. Volatile or
intravenous anesthesia is permitted. There will be no limitation on ancillary vasoactive,
chronotropic, and inotropic drugs. Clinicians will be free to use advanced hemodynamic
monitoring (e.g., pulse-wave analysis, esophageal Doppler, etc.). Blood products will be
given per routine. Similarly, postoperative analgesic management will be per routine and
clinician preference. Neuraxial and peripheral nerve blocks are permitted, but epidural
catheters should not be activated until surgery is nearly finished.
In all cases, good judgement will predominate. Clinicians should always act in their
patients' best interests, irrespective of the GUARDIAN protocol.