NCT00959569

Brief Summary

This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

8.8 years

First QC Date

August 13, 2009

Last Update Submit

October 9, 2018

Conditions

Cardiac Surgery

Keywords

esmololcardiac surgerycardiac anesthesiamortalitybeta blockersbeta-blockerscardiac protection

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay.

    Hospital stay (approximately 2 weeks)

Secondary Outcomes (4)

  • Number of patients with ventricular fibrillation after cardiopulmonary bypass

    30 days and 1 year

  • Number of patients with low cardiac output syndrome

    30 days and 1 year

  • Number of patients requiring post-operative inotropic support

    30 days and 1 year

  • peak postoperative cardiac troponin level

    30 days and 1 year

Study Arms (2)

esmolol

EXPERIMENTAL

the study group will receive esmolol (1-3 mg/kg)

Drug: Esmolol

normosaline

PLACEBO COMPARATOR

normosaline (same ml of the study drug)

Drug: Placebo

Interventions

EsmololDRUG

esmolol (1-3 mg/kg) during cardiac surgery

Also known as: Beta-blocker; Beta blocker; breviblock
esmolol
PlaceboDRUG

normosaline (same ml of the study drug)

normosaline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • end diastolic diameter \>60 mm and/or an ejection fraction \<50%
  • written informed consent
  • age \>18 years

You may not qualify if:

  • previous unusual response to esmolol
  • esmolol administration in the previous 30 days
  • emergency operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vita-Salute University

Milan, Italy

Location

Related Publications (4)

  • Zangrillo A, Turi S, Crescenzi G, Oriani A, Distaso F, Monaco F, Bignami E, Landoni G. Esmolol reduces perioperative ischemia in cardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):625-32. doi: 10.1053/j.jvca.2009.01.003. Epub 2009 Mar 18.

    PMID: 19297196BACKGROUND

  • Crescenzi G, Rosica C, Marino G, Serini SM, Covello RD, Landoni G, Zangrillo A. The use of esmolol to treat systolic anterior motion of the mitral valve after mitral valve repair. Eur J Anaesthesiol. 2008 Apr;25(4):342-3. doi: 10.1017/S0265021507002876. No abstract available.

    PMID: 18334040BACKGROUND

  • Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. doi: 10.2174/138945009789108837. Epub 2009 Sep 1.

    PMID: 19538174BACKGROUND

  • Crescenzi G, Landoni G, Zangrillo A, Guarracino F, Rosica C, La Canna G, Alfieri O. Management and decision-making strategy for systolic anterior motion after mitral valve repair. J Thorac Cardiovasc Surg. 2009 Feb;137(2):320-5. doi: 10.1016/j.jtcvs.2008.08.018.

    PMID: 19185145BACKGROUND

MeSH Terms

Interventions

esmololAdrenergic beta-Antagonists

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

August 1, 2009

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

October 10, 2018

Record last verified: 2018-10

Locations

IT(1)