ACEI/ARB Study in Ambulatory and Day of Surgery Admission Patients (ACE/ARB)
Primary Purpose
Hypertension, Hypotension
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACEI or ARB
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- patients over the age of 18
- patients scheduled to undergo any surgical procedure on an ambulatory basis or on a same day admission basis
- patients undergoing general anesthesia by Laryngeal Mask Airway (LMA)
- patients taking chronic ACEI or ARB drug treatment for hypertension for more than 6 weeks
- patients on diuretics and/or beta blockers and/or calcium channel blockers for hypertension in addition to the ACEI or ARB (alone or in combination) for hypertension may be included
- patients taking any cardiovascular medications may be included
Exclusion Criteria:
- patients taking both an ACEI and an ARB simultaneously
- patients taking ACEI or ARB for less than 6 weeks
- patients with uncontrolled hypertension during pre-surgical testing (PST) visit, defined as Systolic (SBP) > 180 or Diastolic (DBP) > 100 (Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure JNC 7)
- patients with history of unstable heart disease, refractory congestive heart failure, hypertensive stroke, mini stroke, stroke or heart attack within the past 6 months
- emergency surgery
- patients who are pregnant
- patients whose surgery requires endotracheal intubation
Sites / Locations
- SUNY Downstate Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Discontinue ACEI or ARB
Continue ACEI or ARB
Arm Description
Patients in this group will not take the ACE or ARB 24 hours prior to their procedure.
Patients in this group will take an ACE or ARB on the day of surgery.
Outcomes
Primary Outcome Measures
Presence of moderate hypotension
Presence of moderate hypotension (SBP<90 or a change of >30% from pre-induction baseline), in the intraoperative setting and in the post-anesthesia care unit
Presence of severe hypotension
Presence of severe hypotension (SBP<65) between induction and incision
Secondary Outcome Measures
The prevalence of cancellation of surgery secondary to unstable BP
The number and dose of medications to treat BP
prevalence of adverse effects (increased length of stay in the PACU, unanticipated hospitalizations, myocardial ischemia, stroke, death)
Full Information
NCT ID
NCT03121092
First Posted
April 11, 2017
Last Updated
April 14, 2017
Sponsor
State University of New York - Downstate Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03121092
Brief Title
ACEI/ARB Study in Ambulatory and Day of Surgery Admission Patients
Acronym
ACE/ARB
Official Title
Should Ambulatory Surgery and Day of Surgery Admission Patients Discontinue Angiotensin Converting Enzyme Inhibitors (ACEI's) and Angiotension Receptor Blockers (ARB's) Preoperatively?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to difficulty with recruiting patients meeting the inclusion criteria the PI decided to retire this project.
Study Start Date
May 16, 2012 (Actual)
Primary Completion Date
March 7, 2017 (Actual)
Study Completion Date
March 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State University of New York - Downstate Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) are commonly used anti-hypertensive medications that may have implications on the management of a patient undergoing surgery. Limited research has looked at the effects of these medications on perioperative complications and mortality. Some studies conducted on small groups of inpatients with advanced vascular disease undergoing vascular surgery or coronary artery bypass grafting (CABG), suggest exacerbation of hypotension (low blood pressure) in patients who continued taking ACEI's or ARB's on the morning of their procedure. In addition, cases of low blood pressure (BP) that were refractory to standard treatment were reported. One recent retrospective study reported no difference in severe hypotension and only a modest difference in moderate hypotension managed by conventional treatment, but did not adequately address the risk of preoperative hypertension. A study recently published by the investigators (Twersky et al., 2014) in over 600 patients demonstrated no difference in preoperative hypertension in ambulatory surgery and same day admission patients. There has been limited data stratifying the degree of low BP based on severity but these were not done in ambulatory patients, and neither was the degree of high BP from discontinuing these medications addressed. As such, no uniform consensus has been reached and clinicians are unclear as to whether the reported inpatient findings are applicable to the outpatients, since they differ in many respects. The investigators propose to evaluate whether ACEI's and ARB's discontinued preoperatively have a negative impact on perioperative hemodynamics and patient outcome in a group of ambulatory and same day surgical patients. Similar to studies done on inpatients, the investigators will also evaluate patients receiving a standardized general anesthetic for hemodynamics following induction of anesthesia until surgical incision.
The investigators hypothesize that continuing ACEI's and ARB's in the preoperative period does not result in an increased risk of severe hypotension (low blood pressure) following induction of general anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypotension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Discontinue ACEI or ARB
Arm Type
No Intervention
Arm Description
Patients in this group will not take the ACE or ARB 24 hours prior to their procedure.
Arm Title
Continue ACEI or ARB
Arm Type
Active Comparator
Arm Description
Patients in this group will take an ACE or ARB on the day of surgery.
Intervention Type
Drug
Intervention Name(s)
ACEI or ARB
Intervention Description
Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) - commonly used anti-hypertensive medications
Primary Outcome Measure Information:
Title
Presence of moderate hypotension
Description
Presence of moderate hypotension (SBP<90 or a change of >30% from pre-induction baseline), in the intraoperative setting and in the post-anesthesia care unit
Time Frame
Through study completion, projected 2-3 years
Title
Presence of severe hypotension
Description
Presence of severe hypotension (SBP<65) between induction and incision
Time Frame
Through study completion, projected 2-3 years
Secondary Outcome Measure Information:
Title
The prevalence of cancellation of surgery secondary to unstable BP
Time Frame
Through study completion, projected 2-3 years
Title
The number and dose of medications to treat BP
Time Frame
Through study completion, projected 2-3 years
Title
prevalence of adverse effects (increased length of stay in the PACU, unanticipated hospitalizations, myocardial ischemia, stroke, death)
Time Frame
Through study completion, projected 2-3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients over the age of 18
patients scheduled to undergo any surgical procedure on an ambulatory basis or on a same day admission basis
patients undergoing general anesthesia by Laryngeal Mask Airway (LMA)
patients taking chronic ACEI or ARB drug treatment for hypertension for more than 6 weeks
patients on diuretics and/or beta blockers and/or calcium channel blockers for hypertension in addition to the ACEI or ARB (alone or in combination) for hypertension may be included
patients taking any cardiovascular medications may be included
Exclusion Criteria:
patients taking both an ACEI and an ARB simultaneously
patients taking ACEI or ARB for less than 6 weeks
patients with uncontrolled hypertension during pre-surgical testing (PST) visit, defined as Systolic (SBP) > 180 or Diastolic (DBP) > 100 (Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure JNC 7)
patients with history of unstable heart disease, refractory congestive heart failure, hypertensive stroke, mini stroke, stroke or heart attack within the past 6 months
emergency surgery
patients who are pregnant
patients whose surgery requires endotracheal intubation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ketan Shevde, MD
Organizational Affiliation
State University of New York - Downstate Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rebecca Twersky, MD, MPH
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24681657
Citation
Twersky RS, Goel V, Narayan P, Weedon J. The risk of hypertension after preoperative discontinuation of angiotensin-converting enzyme inhibitors or angiotensin receptor antagonists in ambulatory and same-day admission patients. Anesth Analg. 2014 May;118(5):938-44. doi: 10.1213/ANE.0000000000000076.
Results Reference
result
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ACEI/ARB Study in Ambulatory and Day of Surgery Admission Patients
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