Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol

NCT01404767 | Terminated Phase 4 DMC

• 1 other identifier: 10-0713-A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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who has been continued on metoprolol (administrated via a nasogastric tube in NPO patients) to a group who has been withdrawn from metoprolol but given an esmolol infusion titrated to HR.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.

Conditions

Vascular Disease; Hypertension; Angina; Cardiac Disease

Keywords

Vascular surgery; esmolol; hemodynamic control

Outcome Measures

Primary Outcomes (1)

• The difference between plasma levels of metoprolol within two groups

  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.

  0,1, 2, 4, 8, 12, 24 hours post intervention

Secondary Outcomes (1)

• The amount of time the target heart rate is maintained and the incidence of perioperative hypotension and bradycardia.

  Data will be recorded for 48 hours from arrive to the recovery area

Study Arms (2)

Metoprolol oral dose or Placebo infusion

ACTIVE COMPARATOR

Drug: Metoprolol

Esmolol infusion or Placebo oral dose

EXPERIMENTAL

Drug: Esmolol

Interventions

Esmolol DRUG

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.

Esmolol infusion or Placebo oral dose

Metoprolol DRUG

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).

Metoprolol oral dose or Placebo infusion

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

University Heatlh Network, Toronto General Hopsital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Vascular Diseases; Hypertension; Angina Pectoris; Heart Diseases

Interventions

esmolol; Metoprolol

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Myocardial Ischemia; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Scott Beattie, MD, FRCP

  University Health Network, Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: July 28, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2013
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

CA (1)