No registrations found.
ID
Source
Brief title
Health condition
atherosclerosis, vascular surgery, esmolol, cardiac complications
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time with a heart rate outside the 60-80 BPM target window during the study drug infusion period.
Secondary outcome
1. The occurence of cardiac death and myocardial ischemia;
2. Safety parameters such as bradycardia, hypotension, TIA/Stroke.
Background summary
This study will provide data on the efficacy of esmolol titration in
chronic beta-blocker users for tight heart rate control and reduction of
ischemia in patients undergoing vascular surgery as well as data on safety
parameters.
Study objective
Perioperative esmolol infusion titrated for heart rate control as an add-on to standard therapy including a long acting oral beta-blocker will improve heart rate control and decrease perioperative myocardial ischemia, without an increase in complications as bradycardia, hypotension, heart failure and stroke.
Study design
1. During study drug infusion;
2. Follow-up 30 days.
Intervention
Infusion of esmolol or placebo, initiated during surgery for 24 hours, titrated for a target heart rate of 60-80 BPM, as an add-on to standard therapy including long acting, chronic, oral beta-blocker therapy.
Department of Anesthesiology
D. Poldermans
Dr. Molewaterplein 40
Rotterdam 3015 GD
The Netherlands
+31 10 4634613
d.poldermans@erasmusmc.nl
Department of Anesthesiology
D. Poldermans
Dr. Molewaterplein 40
Rotterdam 3015 GD
The Netherlands
+31 10 4634613
d.poldermans@erasmusmc.nl
Inclusion criteria
Adult patient undergoing elective major vascular surgery.
Exclusion criteria
1. Bleeding;
2. Unstable cardiac conditions;
3. Contraindications for esmolol use;
4. Failure to provide informed consent;
5. Cancer with life expectancy <6 months;
6. Alcohol abuse;
7. Failure to monitor heart rate and ischemia by continuous 12-lead ECG recording.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2498 |
| NTR-old | NTR2615 |
| CCMO | NL33197.078.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON34500 |