Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery

Myocardial Ischemia Clinical Trial

Official title:

Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715869
• Other study ID #: IRB00009901
• Status: Completed
• Phase: N/A
• First received: March 17, 2016
• Last updated: December 9, 2017
• Start date: March 2016
• Est. completion date: June 2017

Study information

• Verified date: December 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical).

Description:

Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be ( ischemic ; pharmacologic or Physical)

Pharmacological PC may be induced by variable agents e.g. (Sevoflurane ;isoflorane, opioids etc)

Ischemic PC includes local; remote and the idea is temporary interruption of blood supply to the organ so that liberation of protective mediators occurs. The liberated mediators have favorable effects not only upon the myocardium, but it extend to protect other organs against inflammatory activation; ischemia reperfusion injury

Inotropic score (IS) is already an evident predictor of postoperative cardiac morbidity and mortality

Aim of the work:

Is to validate the impact of Sevoflurane versus ischemic & Sevoflurane PC upon postoperative inotropic score in adult patient undergoing open heart surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 18-60 years old

• American Society of Anesthesiologists physical status II and III

• Patients scheduled for open heart surgery

Exclusion Criteria:

• Emergency surgery

• Clinically significant kidney or liver disease

• Patients allergic to local anesthetic

• Patients with prolonged cardiopulmonary bypass time (>120 min)

• Patients required intra-aortic balloon pump

• Postoperative hemodynamic instability (including the occurrence of serious arrhythmia) or bleeding that required surgical re-exploration

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Drug:
• A pharmacologic cardiac preconditioning (Sevoflurane)
A Patients are anaesthetized by Sevoflurane more than 1 mac.

Procedure:
• B ischeamic preconditioning
B ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Highest inotropic score		first 24 hour