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

Not Applicable

• Conditions: Cardioplegia Solution Adverse Reaction
• Interventions: Drug: Potassium Cardioplegic Solution; Drug: Esmolol

• Registration Number: NCT04306913
• Lead Sponsor: Kasr El Aini Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-13
• Last Update Posted: 2020-03-13
• Study Start: 2020-04
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Potassium Cardioplegic Solution	-
Esmolol	Potassium Cardioplegic Solution	-
Esmolol	Esmolol	-

Primary Outcome Measures

Name	Time	Method
Coronary sinus lactate level immediately before declamping the aorta.	1 hour during declamping	the lactate from the coronary sinus

Trial Locations

Locations (1)

Kasr alainy medical school; 🇪🇬 Cairo, Egypt