Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol
|ClinicalTrials.gov Identifier: NCT01404767|
Recruitment Status : Terminated (Enrollment slow over 2 years a change in the population less on metoprolol than initially anticipated)
First Posted : July 28, 2011
Last Update Posted : April 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Vascular Disease Hypertension Angina Cardiac Disease||Drug: Esmolol Drug: Metoprolol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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)|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||December 2013|
|Active Comparator: Metoprolol oral dose or Placebo infusion||
The night and morning before surgery, the patients in the metoprolol arm will receive their standard dose of beta blocker metoprolol.These patients will receive their daily beta blockers orally or via nasogastric tube postoperatively if they are NPO (Group A).
|Experimental: Esmolol infusion or Placebo oral dose||
Baseline treatment consists of a bolus of 500ug/kg/min followed by an infusion of 50ug/kg/min for 4 minutes and titrating in increment of 50ug/kg/min up to a maximum of 300ug/kg/min to maintain a HR within 10% of the target HR (≤ 70 bpm), which is 70± 7 bpm.
- The difference between plasma levels of metoprolol within two groups [ Time Frame: 0,1, 2, 4, 8, 12, 24 hours post intervention ]Comparisons measured in the pre-operative to intra-operative and post operative periods within metoprolol arm as well as between esmolol arm and metoprolol arm. Plasma levels will be correlated with both the hemodynamic response (HR) and the incidence of postoperative ischemia. The covariates (HR, BP, HR variability, etc) on PK/PD correlation will be examined.
- The amount of time the target heart rate is maintained and the incidence of perioperative hypotension and bradycardia. [ Time Frame: Data will be recorded for 48 hours from arrive to the recovery area ]Additional assessments include cardiovascular morbidity and mortality including 30-day mortality, myocardial infarction, new cardiac arrhythmia, congestive heart failure, and renal failure, the incidence of post operative delirium, transient ischemic attack, stroke, and length of hospital stay.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404767
|University Heatlh Network, Toronto General Hopsital|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Scott Beattie, MD, FRCP||University Health Network, Toronto General Hospital|