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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 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.
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
Interventions
- DRUG ACEI or ARB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2012-05-16 |
| Est. Completion | 2017-03-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03121092
The ClinicalTrials.gov registry entry for NCT03121092 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York - Downstate Medical Center, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ACEI or ARB is the first listed.
NCT03121092 reports 0 study locations.
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.
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