Outcome of Esmolol Potassium Cardioplegia Compared to Pot... | NCT04306913

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2020Estimated

Primary Completion Date

Sep 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Mar 2, 2020

First Submission Date that Met QC Criteria

Mar 10, 2020

First Posted Date

Mar 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2020

Last Update Posted Date

Mar 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator		Drug: Potassium Cardioplegic Solution
Esmolol	Experimental		Drug: Esmolol Drug: Potassium Cardioplegic Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Esmolol	Drug	esmolol 250 mg in cardioplegia solution every 25 minutes	Esmolol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coronary sinus lactate level immediately before declamping the aorta.	the lactate from the coronary sinus	1 hour during declamping

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ayman Abougabal, PHD	Contact	00201020671408		ayman.abouagabal@kasralainy.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr alainy medical school		Cairo		12566	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12771874	Background	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.
19156237

ID	Term
C036604	esmolol
C018369	potassium cardioplegic solution