Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04789733
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2021-01-14
Brief Title:
The GUARDIAN Pilot Trial
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular Renal and Cognitive Complications The GUARDIAN Pilot Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GUARDIAN
Brief Summary:
The treatments will be 1 norepinephrine or phenylephrine infusion to maintain intraoperative MAP 85 mmHg delayed resumption of chronic antihypertensive medications and a target ward MAP 80 mmHg tight pressure management or 2 routine intraoperative blood pressure management and prompt resumption of chronic antihypertensive medications routine pressure management
Detailed Description:
Consenting patients who take either angiotensin converting enzyme inhibitors ACEIs angiotensin receptor blockers ARBs or calcium channel blockers will be asked not to take the medications on the morning of surgery and instead bring them with them to the hospital Qualifying patients will be randomized 11 with random-sized blocks
Randomization will be implemented by clinicians in collaboration with research personnel Arterial catheter transducers will be positioned at the level of the right atrium and adjusted as necessary if patient position is changed
The treatments will be 1 norepinephrine or phenylephrine infusion to maintain intraoperative MAP 85 mmHg delayed resumption of chronic antihypertensive medications and a target ward MAP 80 mmHg tight pressure management or 2 routine intraoperative blood pressure management and prompt resumption of chronic antihypertensive medications 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 Clinicians will be encouraged to insert the required arterial catheter before anesthetic induction because much hypotension occurs shortly after anesthetic induction
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
Resumption of chronic anti-hypertensive medications will be delayed until the third postoperative day unless deemed necessary to treat hypertension or for some other clear indication eg preventing atrial fibrillation in a chronic beta-blocker user because 90 of MINS occurs within 48 hours after surgery When necessary to treat hypertension chronic antihypertensive or new medications can be used per clinician preference Clinicians will make what efforts they can to maintain postoperative mean arterial pressures 80 mmHg during the initial three postoperative days by maintaining adequate hydration using inotropic and chronotropic drugs and vasopressor as necessary This protocol specifies the blood pressure target but leaves implementation to clinical judgement
Routine pressure management In patients assigned to routine pressure management ACEIs ARBs andor calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist The arterial catheter will be inserted before or after induction of anesthesia per clinician preference 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 65 mmHg As usual chronic anti-hypertensive medications will be restarted shortly after surgery unless contraindicated by hypotension
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 eg 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
Because patients must be fairly sick to qualify for GUARDIAN some will go to directly from surgery to critical care units or much less often become unstable and require transfer from a routine ward to an ICU In either case every effort will be to maintain randomized treatments and blood pressure targets
In all cases good judgement will predominate Clinicians should always act in their patients best interests irrespective of the GUARDIAN protocol
Randomization will be implemented by clinicians in collaboration with research personnel Arterial catheter transducers will be positioned at the level of the right atrium and adjusted as necessary if patient position is changed
The treatments will be 1 norepinephrine or phenylephrine infusion to maintain intraoperative MAP 85 mmHg delayed resumption of chronic antihypertensive medications and a target ward MAP 80 mmHg tight pressure management or 2 routine intraoperative blood pressure management and prompt resumption of chronic antihypertensive medications 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 Clinicians will be encouraged to insert the required arterial catheter before anesthetic induction because much hypotension occurs shortly after anesthetic induction
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
Resumption of chronic anti-hypertensive medications will be delayed until the third postoperative day unless deemed necessary to treat hypertension or for some other clear indication eg preventing atrial fibrillation in a chronic beta-blocker user because 90 of MINS occurs within 48 hours after surgery When necessary to treat hypertension chronic antihypertensive or new medications can be used per clinician preference Clinicians will make what efforts they can to maintain postoperative mean arterial pressures 80 mmHg during the initial three postoperative days by maintaining adequate hydration using inotropic and chronotropic drugs and vasopressor as necessary This protocol specifies the blood pressure target but leaves implementation to clinical judgement
Routine pressure management In patients assigned to routine pressure management ACEIs ARBs andor calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist The arterial catheter will be inserted before or after induction of anesthesia per clinician preference 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 65 mmHg As usual chronic anti-hypertensive medications will be restarted shortly after surgery unless contraindicated by hypotension
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 eg 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
Because patients must be fairly sick to qualify for GUARDIAN some will go to directly from surgery to critical care units or much less often become unstable and require transfer from a routine ward to an ICU In either case every effort will be to maintain randomized treatments and blood pressure targets
In all cases good judgement will predominate Clinicians should always act in their patients best interests irrespective of the GUARDIAN protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None