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

Kasr El Aini Hospital

Status: Unknown

Conditions: Cardioplegia Solution Adverse Reaction

Treatments: Drug: Esmolol; Drug: Potassium Cardioplegic Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04306913

D-47-2019

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Control

Active Comparator group

Treatment:

Drug: Potassium Cardioplegic Solution

Esmolol

Experimental group

Treatment:

Drug: Esmolol

Drug: Potassium Cardioplegic Solution