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NCT03121092 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by State University of New York - Downstate Medical Center.

Terminated
Registry status
NA
Development phase
188
Enrollment target

NCT03121092: Clinical Trial NA study, sponsored by State University of New York - Downstate Medical Center.

NCT03121092 is a NA study that was terminated before completion, run by State University of New York - Downstate Medical Center. The registered enrollment target is 188 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03121092, a NA study, was terminated before completion, sponsored by State University of New York - Downstate Medical Center.

TERMINATED
Registry status
NA
Development phase
188 participants
Enrollment target

Study 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

Primary Outcome

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

Interventions

  • DRUG ACEI or ARB

Trial Details

FieldValue
Enrollment Target 188 participants
Start Date 2012-05-16
Est. Completion 2017-03-07
Phase NA

Why NCT03121092 stopped before completion

NCT03121092 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 1 intervention - of which ACEI or ARB is the first listed.

NCT03121092 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03121092 about?

NCT03121092 is a clinical study titled "ACEI/ARB Study in Ambulatory and Day of Surgery Admission Patients". 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 c...

What is the current status of trial NCT03121092?

This trial is currently terminated. It is a NA study. The enrollment target is 188 participants. The study started on 2012-05-16. Estimated completion is 2017-03-07.

What interventions are being tested in trial NCT03121092?

The interventions under investigation include: ACEI or ARB (DRUG).

Who is sponsoring clinical trial NCT03121092?

This trial is sponsored by State University of New York - Downstate Medical Center, which has 18 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03121092's enrollment target sits among peer trials

188 576th of 2000 higher than 1,422 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03121092, the US trial registry maintained by the National Library of Medicine. NCT03121092 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.