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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardioplegia Solution Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Potassium Cardioplegic Solution

Intervention Type DRUG

15 meq potassium added to cardioplegia solution

Esmolol

Group Type EXPERIMENTAL

Esmolol

Intervention Type DRUG

esmolol 250 mg in cardioplegia solution every 25 minutes

Potassium Cardioplegic Solution

Intervention Type DRUG

15 meq potassium added to cardioplegia solution

Interventions

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Esmolol

esmolol 250 mg in cardioplegia solution every 25 minutes

Intervention Type DRUG

Potassium Cardioplegic Solution

15 meq potassium added to cardioplegia solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No