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Clinical Trial Details

Overview

Research Study Summary

A Phase 4 clinical study for patients with Vascular Disease, Hypertension, Angina or Cardiac Disease

Research Study Title

Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol: A Study Comparing the Post Op Continuation of the Preoperative Oral Dose Beta Blockers to Intravenous Esmolol Titrated to a Target Heart Rate (HR)

Purpose

This study proposes to assess the effect of the standard of care, which is continuation of the pre op beta blocker dose into the post operative period compared to the administration of esmolol titrated to a pre determined target HR. The primary outcome will compare postoperative plasma levels of metoprolol in 2 cohorts in a group who has been continued on metoprolol (administrated via a nasogastric tube in NPO patients) to a group who has been withdrawn from metoprolol but given an esmolol infusion titrated to HR. Secondary outcomes will compare a) the hemodynamic responses, documenting the incidence of unplanned hypotension and bradycardia and b) to compare the effects of Heart rate to the incidence of myocardial ischemia, arrhythmias, delirium and infarction.

To Learn more
Phase

4

Gender

Both Male and Female

Age

20 to 80 Years

Overall Status

Recruiting

Lead Sponsor

University Health Network, Toronto

Duration

28 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 20 Years to 80 Years

Patient inclusion criteria:

  • Elective vascular surgery

  • Any of the following co morbidities

  • Diabetes

  • Angina

  • Congestive heart failure

  • A serum creatinine above 176 mmol/l

  • All patients must be on stable dose of oral metoprolol (≥ 30 days)

  • Age ≥ 20 years and ≤ 80 years

  • Written informed consent to participate to the study

Patient exclusion criteria:

  • Inability to understand the study protocol

  • Prior gastric surgery or small bowel resection

  • Pacemaker ( since it precludes the measurement of ST changes)

  • Malabsorption syndromes

  • Body Mass Index < 18 and > 35

  • Any patient with suspected of diagnosed Cerebral vascular disease. (We chose to exclude CVA patients due to the ongoing controversy about the increased incidence of stroke in patients have surgery and who are taking beta-blockers.)

Site Locations (1)

Country State City Zip Facility and Contact
Canada Ontario Toronto M5G 2C4 University Heatlh Network, Toronto General Hopsital
Scott Beattie, MD
416-340-4800 ext. 6934
scott.beattie@uhn.ca

Contact

Jo A Carroll, BHA
416 340-4800 ext. 3243

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01404767

Date Last Changed: October 4, 2013

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