HypertensionACE/ARBNCT03121092
ACEI/ARB Study in Ambulatory and Day of Surgery Admission Patients
A study testing ACEI or ARB in people with Hypertension and Hypotension, run by State University of New York - Downstate Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Hypotension
- What is being tested?
- ACEI or ARB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2012to 7 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Downstate Medical Center
Brooklyn, New York, 11203
About this study
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?
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.
- Conditions
- Hypertension, Hypotension
- Being tested
- ACEI or ARB
- Medical subject headings
- Hypertension, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACEI or ARBDrug
Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) - commonly used anti-hypertensive medications
| Study group | Role | What they receive |
|---|---|---|
| Discontinue ACEI or ARB | No intervention | Patients in this group will not take the ACE or ARB 24 hours prior to their procedure. |
| Continue ACEI or ARB | Active comparator | Patients in this group will take an ACE or ARB on the day of surgery. Receives: Drug: ACEI or ARB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, projected 2-3 years
Presence of severe hypotension
Presence of severe hypotension (SBP<65) between induction and incision
Measured: Through study completion, projected 2-3 years
Secondary outcomes (3)
The prevalence of cancellation of surgery secondary to unstable BP
Measured: Through study completion, projected 2-3 years
The number and dose of medications to treat BP
Measured: Through study completion, projected 2-3 years
prevalence of adverse effects (increased length of stay in the PACU, unanticipated hospitalizations, myocardial ischemia, stroke, death)
Measured: Through study completion, projected 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start16 May 2012
- Primary completion7 Mar 2017
- Study completion7 Mar 2017
Why it stopped: Due to difficulty with recruiting patients meeting the inclusion criteria the PI decided to retire this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ketan Shevde, MD, Principal investigator, State University of New York - Downstate Medical CenterRebecca Twersky, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121092
- Sponsor's protocol ID
- 303066-1
- Acronym
- ACE/ARB
- Status last verified
- Apr 2017
- First submitted
- 11 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24681657
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03121092
- Acronym / sponsor ID
- ACE/ARB / 303066-1
- Conditions
- Hypertension, Hypotension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulty with recruiting patients meeting the inclusion criteria the PI decided to retire this project.
- Enrolment
- 188 participants (actual)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Study start
- 16 May 2012 (actual)
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 7 Mar 2017 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discontinue ACEI or ARB | No intervention | –Patients in this group will not take the ACE or ARB 24 hours prior to their procedure. |
| Continue ACEI or ARB | Active comparator | Drug: ACEI or ARBPatients in this group will take an ACE or ARB on the day of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACEI or ARBAngiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) - commonly used anti-hypertensive medications | Drug | Continue ACEI or ARB |
Primary outcome
Presence of moderate hypotension
Time frame: Through study completion, projected 2-3 years
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
Time frame: Through study completion, projected 2-3 years
Presence of severe hypotension (SBP<65) between induction and incision
3 secondary outcomes
The prevalence of cancellation of surgery secondary to unstable BP
Time frame: Through study completion, projected 2-3 years
The number and dose of medications to treat BP
Time frame: Through study completion, projected 2-3 years
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
Results and safety
The study was stopped early (reason given: Due to difficulty with recruiting patients meeting the inclusion criteria the PI decided to retire this project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Results publication: PubMed 24681657Twersky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ketan Shevde, MD principal investigator
State University of New York - Downstate Medical Center
Rebecca Twersky, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACEI or ARB in people with Hypertension and Hypotension, run by State University of New York - Downstate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to difficulty with recruiting patients meeting the inclusion criteria the PI decided to retire this project.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of moderate hypotension (time frame: Through study completion, projected 2-3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03121092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.