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

Primary Purpose

Myocardial Ischemia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

A pharmacologic cardiac preconditioning (Sevoflurane)

B ischeamic preconditioning

About this trial

This is an interventional supportive care trial for Myocardial Ischemia focused on measuring Myocardial Preconditioning, inotropic score

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

A pharmacologic cardiac preconditioning

B ischeamic preconditioning

Arm Description

Sevoflurane as a pharmacologic preconditioner for the heart

ischemic preconditioning by inflation the cuff of blood pressure

Outcomes

Primary Outcome Measures

Highest inotropic score

Secondary Outcome Measures

Full Information

NCT ID

NCT02715869

First Posted

March 17, 2016

Last Updated

December 9, 2017

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT02715869

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Ischemia

Keywords

Myocardial Preconditioning, inotropic score

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A pharmacologic cardiac preconditioning

Arm Type

Active Comparator

Arm Description

Sevoflurane as a pharmacologic preconditioner for the heart

Arm Title

B ischeamic preconditioning

Arm Type

Active Comparator

Arm Description

ischemic preconditioning by inflation the cuff of blood pressure

Intervention Type

Drug

Intervention Name(s)

A pharmacologic cardiac preconditioning (Sevoflurane)

Intervention Description

A Patients are anaesthetized by Sevoflurane more than 1 mac.

Intervention Type

Procedure

Intervention Name(s)

B ischeamic preconditioning

Intervention Description

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

Primary Outcome Measure Information:

Title

Highest inotropic score

Time Frame

first 24 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emad Zarief Kamel Said, M.D.

Organizational Affiliation

Department of Anesthesia, faculty of Medicine, Assiut University

Official's Role

Study Director

Facility Information:

Facility Name

Emad Zarief Kamel Said

City

Assiut

ZIP/Postal Code

71111

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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