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

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.

Study Overview

• Status: Unknown
• Conditions: Cardioplegia Solution Adverse Reaction
• Intervention / Treatment: Drug: Potassium Cardioplegic Solution; Drug: Esmolol

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12566
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Drug: Potassium Cardioplegic Solution; 15 meq potassium added to cardioplegia solution
Experimental: Esmolol	Drug: Potassium Cardioplegic Solution; 15 meq potassium added to cardioplegia solution; Drug: Esmolol; esmolol 250 mg in cardioplegia solution every 25 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coronary sinus lactate level immediately before declamping the aorta.	the lactate from the coronary sinus	1 hour during declamping

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmaceutical Solutions; Adrenergic beta-1 Receptor Antagonists; Esmolol; Cardioplegic Solutions
• Other Study ID Numbers: D-47-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No