ACEI/ARB Study in Ambulatory and Day of Surgery Admission Patients

NCT03121092 | Terminated

• 1 other identifier: 303066-1
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Hypotension

Outcome Measures

Primary Outcomes (2)

• 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

  Through study completion, projected 2-3 years

• Presence of severe hypotension

  Presence of severe hypotension (SBP\<65) between induction and incision

  Through study completion, projected 2-3 years

Secondary Outcomes (3)

• The prevalence of cancellation of surgery secondary to unstable BP

  Through study completion, projected 2-3 years

• The number and dose of medications to treat BP

  Through study completion, projected 2-3 years

• prevalence of adverse effects (increased length of stay in the PACU, unanticipated hospitalizations, myocardial ischemia, stroke, death)

  Through study completion, projected 2-3 years

Study Arms (2)

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.

Drug: ACEI or ARB

Interventions

ACEI or ARB DRUG

Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) - commonly used anti-hypertensive medications

Continue ACEI or ARB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Related Publications (1)

• 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.

  PMID: 24681657 RESULT

MeSH Terms

Conditions

Hypertension; Hypotension

Interventions

Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ketan Shevde, MD

  State University of New York - Downstate Medical Center

  PRINCIPAL INVESTIGATOR

• Rebecca Twersky, MD, MPH

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 19, 2017
• Study Start: May 16, 2012
• Primary Completion: March 7, 2017
• Study Completion: March 7, 2017
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

US (1)