Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Solitary Valvular Disease; Randomized Controlled Study

Cardioplegia Solution Adverse Reaction Clinical Trial

Official title:

Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Solitary Valvular Disease; Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04306913
• Other study ID #: D-47-2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2020
• Est. completion date: September 2020

Study information

• Verified date: March 2020
• Source: Kasr El Aini Hospital
• Contact: Ayman Abougabal, PHD
• Phone: 00201020671408
• Email: ayman.abouagabal[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• • 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

Related Conditions & MeSH terms

• Cardioplegia Solution Adverse Reaction

Intervention

Drug:
• Esmolol
esmolol 250 mg in cardioplegia solution every 25 minutes
• Potassium Cardioplegic Solution
15 meq potassium added to cardioplegia solution

Locations

Country	Name	City	State
Egypt	Kasr alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Kuhn-Régnier F, Natour E, Dhein S, Dapunt O, Geissler HJ, LaRosé K, Görg C, Mehlhorn U. Beta-blockade versus Buckberg blood-cardioplegia in coronary bypass operation. Eur J Cardiothorac Surg. 1999 Jan;15(1):67-74. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary sinus lactate level immediately before declamping the aorta.	the lactate from the coronary sinus	1 hour during declamping