Primary Objective: comparing hemodynamic stability provided by titration of esmolol in addition to standard perioperative care including low-dose metoprolol to placebo and standard care.Secondary Objective(s): -comparing the incidence of…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is hemodynamic stability during the first 24 hours after
the start of surgery, where hemodynamic stability is defined as total length of
heart rate outside the target window presented in minutes. the target window is
defined as a heart rate between 60 and 80 beats per minute.
Secondary outcome
The key secondary study outcome is the occurrence of myocardial ischemia,
defined as either transient electrocardiographic signs of ischemia or Troponin
T release or both. In patients with tachycardia and ischemia, the use of rescue
medication is considered to be a secondary study endpoint as well, where the
dose is noted for every patient. Secondary outcomes also include other safety
parameters such as the occurrence of bradycardia (i.e. HR 50 BPM or less) and
the occurrence of stroke and transient ischemic attacks (TIA). another
secondary outcome measure is 'area under the curve' of episodes of tachycardia.
Background summary
Patients undergoing vascular surgery are likely to have coronary artery disease
and are at increased risk of cardiac morbidity and mortality. Perioperative
hemodynamic stability is associated with an improved outcome. Beta-blockers can
provide hemodynamic stability and reduce the risk of perioperative cardiac
morbidity and mortality in high risk patients. However, a recent study showed
an increase in total mortality and stroke. Episodes of hypotension and
bradycardia were associated with this increased risk and can be related to
high-dose oral long acting beta-blocking agents. Titration of short-acting
intravenous esmolol in combination with a low dose of long acting oral
beta-blocking agent can achieve hemodynamic stability, while preventing
hypotension and bradycardia associated with overdosing of long acting
beta-blocking agents.
Study objective
Primary Objective:
comparing hemodynamic stability provided by titration of esmolol in addition to
standard perioperative care including low-dose metoprolol to placebo and
standard care.
Secondary Objective(s):
-comparing the incidence of postoperative myocardial ischemia in patients
receiving esmolol and standard care versus placebo and standard care.
-comparing safety parameters such as incidence of bradycardia, TIA and stroke
in patients receiving esmolol and standard care versus placebo and standard
care.
Study design
STUDY DESIGN
This randomized study compares a group of patients receiving esmolol as an
add-on to metoprolol to a group of patients receiving metoprolol plus esmolol
placebo . This study compares the combination of metoprolol plus esmolol vs. a
mono therapy of metoprolol. patient and research fellow will be blinded,
attending anesthesiologist and intensivist are not blinded. The use of a
placebo infusion in this study for a total of 24 hours of intra-operative and
post-operative periods is only to facilitate blinding. As the influence of
concomitant medications, anesthesia, and influence of the surgical procedure,
peritoneal traction, on heart rate is recognized, with the use of a placebo,
the effect of esmolol in addition to chronic beta-blocker medication can be
assessed more objectively.
Intervention
if at anytime during surgery tachycardia (HR >80 BPM) is present, a
bolusinjection of 0.25mg/kg esmolol or placebo is administered, followed by a
25 mcg/kg/min continuous infusion. if this situation does not occur during
surgery, a continuous infusion of 25 mcg/kg/min of esmolol or placebo is
initiated prior to extubation.
continuous infusion is titrated at 15 minute intervals with 25% of the current
dose to maintain a heartrate of 60-80 BPM.
esmolol is not initiated in case of hypotension or bradycardia
Study burden and risks
all diagnostic tests and visits to outpatient clinic are part of standard
medical care. A recent review described a similar rate of esmolol associated
complications such as hypotension and bradycardia for patients treated with
esmolol compared to placebo. esmolol or placebo infusion will take place under
continuous hemodynamic monitoring and dose will be adjusted to heartrate and
bloodpressure. Risks and burden for patients are minimal.
's Gravendijkwal
3015CE Rotterdam
NL
's Gravendijkwal
3015CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patients are eligible for inclusion for the study at the Erasmus Medical Centre if they are:
1. Scheduled for arterial vascular surgery, including abdominal aortic aneurysm repair, abdominal aortic stenosis surgery, lower limb arterial reconstruction or carotid artery stenosis repair
2. Provide informed consent
Exclusion criteria
Potential subjects will be excluded with any of the following:
1. Active bleeding
2. Untreated left main disease
3. Active cardiac condition such as unstable angina pectoris, active congestive heart failure, serious cardiac arrhythmias, symptomatic valvular disease, recent MI< 6 months.
4. Preoperative positive troponin T
5. Contraindication for esmolol use
6. Previous allergy or intolerance to esmolol
7. Cancer with an expected life expectancy < 6 months
8. Excessive alcohol use
9. Pregnancy or planning to become pregnant
10. Failure to provide informed consent
11.Failure to monitor heart rate with the continuous 12-lead electrocardiography because of surgery or baseline electrocardiographic abnormalities.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-021844-17-NL |
| CCMO | NL33197.078.10 |
| OMON | NL-OMON20345 |