Cardioplegia Solution Adverse Reaction Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr alainy medical school | Cairo |
Lead Sponsor | Collaborator |
---|---|
Kasr El Aini Hospital |
Egypt,
Kuhn-Régnier F, Natour E, Dhein S, Dapunt O, Geissler HJ, LaRosé K, Görg C, Mehlhorn U. Beta-blockade versus Buckberg blood-cardioplegia in coronary bypass operation. Eur J Cardiothorac Surg. 1999 Jan;15(1):67-74. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coronary sinus lactate level immediately before declamping the aorta. | the lactate from the coronary sinus | 1 hour during declamping |
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