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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04306913
Enrollment
80
Registered
2020-03-13
Start date
2020-04-30
Completion date
2020-09-30
Last updated
2020-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardioplegia Solution Adverse Reaction

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.

Interventions

DRUGEsmolol

esmolol 250 mg in cardioplegia solution every 25 minutes

DRUGPotassium Cardioplegic Solution

15 meq potassium added to cardioplegia solution

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Coronary sinus lactate level immediately before declamping the aorta.1 hour during declampingthe lactate from the coronary sinus

Countries

Egypt

Contacts

Primary ContactAyman Abougabal, PHD
ayman.abouagabal@kasralainy.edu.eg00201020671408

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026