Clinical trial NCT04306913: Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Solitary Valvular Disease; Randomized Controlled Study
Official title: Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Solitary Valvular Disease; Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardioplegia Solution Adverse Reaction
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Coronary sinus lactate level immediately before declamping the aorta.
timeFrame: 1 hour during declamping
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr alainy medical school
Study officials:
References:
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. doi: 10.1067/mtc.2003.175.
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.
citation: 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.