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DECREASE-XIII: A randomized study of perioperative esmolol infusion for haemodynamic stability during major vascular surgery.


- candidate number8692
- NTR NumberNTR2615
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-nov-2010
- Secondary IDsNL3319707810 CCMO
- Public TitleDECREASE-XIII: A randomized study of perioperative esmolol infusion for haemodynamic stability during major vascular surgery.
- Scientific TitleDECREASE-XIII: A randomized study of perioperative esmolol infusion for haemodynamic stability during major vascular surgery.
- ACRONYMDECREASE-XIII
- hypothesisPerioperative 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.
- Healt Condition(s) or Problem(s) studiedAtherosclerose, Vascular surgery, Esmolol, Cardiac complications
- Inclusion criteriaAdult patient undergoing elective major vascular surgery.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2010
- planned closingdate1-jul-2013
- Target number of participants260
- InterventionsInfusion 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.
- Primary outcomeTime with a heart rate outside the 60-80 BPM target window during the study drug infusion period.
- Secondary outcome1. The occurence of cardiac death and myocardial ischemia;
2. Safety parameters such as bradycardia, hypotension, TIA/Stroke.
- Timepoints1. During study drug infusion;
2. Follow-up 30 days.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESProf. dr. D. Poldermans
- CONTACT for SCIENTIFIC QUERIESProf. dr. D. Poldermans
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Baxter Healthcare Corporation
- PublicationsN/A
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD22-nov-2010 - 29-jan-2012


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