NCT04306913

Brief Summary

Perioperative myocardial injury remains one of the most serious complications of cardiac surgery. Numerous factors have been implicated during the pathogenesis process, including the technique of cardiac surgery, induction of cardioplegia and period of cardiac arrest. Lactic acid is the normal endpoint of the anaerobic breakdown of glucose in the tissues. The lactate exits the cells and is transported to the liver, thus it's considered to be an indicator of ischemia as it is produced by most tissues in the human body, with the highest level of production found in muscle. In any cardiac valve replacement surgery, patient must undergo cardiac bypass and arrest in diastole by using hyperkalemic cardioplegia solution; meanwhile the metabolism of myocardial cells is purely anaerobic. Esmolol an ultra-short beta blocker is supposed to decrease the anaerobic insult to the myocardial cells.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 2, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 2, 2020

Last Update Submit

March 10, 2020

Conditions

Cardioplegia Solution Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • Coronary sinus lactate level immediately before declamping the aorta.

    the lactate from the coronary sinus

    1 hour during declamping

Study Arms (2)

Control

ACTIVE COMPARATOR
Drug: Potassium Cardioplegic Solution

Esmolol

EXPERIMENTAL
Drug: EsmololDrug: Potassium Cardioplegic Solution

Interventions

EsmololDRUG

esmolol 250 mg in cardioplegia solution every 25 minutes

Esmolol
Potassium Cardioplegic SolutionDRUG

15 meq potassium added to cardioplegia solution

ControlEsmolol

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 20-50 years old patients, with either sex with solitary valvular disease

You may not qualify if:

  • Myocardial infarction within 2 weeks.
  • History of reaction or toxicity to esmolol or other beta blockers.
  • New York Heart Association class IV congestive heart failure despite treatment.
  • Persistent hypotension (systolic blood pressure \<80 mm Hg).
  • severe pulmonary hypertension
  • Ejection fraction less than 45%
  • Patients with coronary artery disease
  • Patients with congenital heart disease
  • Patients with previous cardiac surgery
  • Patients with liver disease (child class B and C)
  • Patients with second or third degree heart block
  • Patients having resting heart rate less than 50 ppm
  • Patients using calcium channel blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr alainy medical school

Cairo, 12566, Egypt

Location

Related Publications (3)

  • Scorsin M, Mebazaa A, Al Attar N, Medini B, Callebert J, Raffoul R, Ramadan R, Maillet JM, Ruffenach A, Simoneau F, Nataf P, Payen D, Lessana A. Efficacy of esmolol as a myocardial protective agent during continuous retrograde blood cardioplegia. J Thorac Cardiovasc Surg. 2003 May;125(5):1022-9. doi: 10.1067/mtc.2003.175.

    PMID: 12771874BACKGROUND

  • Murtuza B, Pepper JR, Stanbridge RD, Darzi A, Athanasiou T. Does minimal-access aortic valve replacement reduce the incidence of postoperative atrial fibrillation? Tex Heart Inst J. 2008;35(4):428-38.

    PMID: 19156237BACKGROUND

  • Kuhn-Regnier F, Natour E, Dhein S, Dapunt O, Geissler HJ, LaRose K, Gorg C, Mehlhorn U. Beta-blockade versus Buckberg blood-cardioplegia in coronary bypass operation. Eur J Cardiothorac Surg. 1999 Jan;15(1):67-74. doi: 10.1016/s1010-7940(98)00289-9.

    PMID: 10077376BACKGROUND

MeSH Terms

Interventions

esmololpotassium cardioplegic solution

Central Study Contacts

Ayman Abougabal, PHD

CONTACT

00201020671408ayman.abouagabal@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 13, 2020

Study Start

April 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

March 13, 2020

Record last verified: 2020-03

Locations

EG(1)