Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Sol… (NCT04306913) | Clinical Trial Compass
UnknownNot Applicable
Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Solitary Valvular Disease; Randomized Controlled Study
Egypt80 participantsStarted 2020-04
Plain-language 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.
Who can participate
Age range
20 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Coronary sinus lactate level immediately before declamping the aorta.