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

NCT ID: NCT02715869

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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

Conditions

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Myocardial Ischemia

Keywords

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Myocardial Preconditioning, inotropic score

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A pharmacologic cardiac preconditioning

Sevoflurane as a pharmacologic preconditioner for the heart

Group Type ACTIVE_COMPARATOR

A pharmacologic cardiac preconditioning (Sevoflurane)

Intervention Type DRUG

A Patients are anaesthetized by Sevoflurane more than 1 mac.

B ischeamic preconditioning

ischemic preconditioning by inflation the cuff of blood pressure

Group Type ACTIVE_COMPARATOR

B ischeamic preconditioning

Intervention Type PROCEDURE

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

Interventions

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A pharmacologic cardiac preconditioning (Sevoflurane)

A Patients are anaesthetized by Sevoflurane more than 1 mac.

Intervention Type DRUG

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Emad Zarief , MD

Lecturer of Anesthesia and critical care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emad Zarief Kamel Said, M.D.

Role: STUDY_DIRECTOR

Department of Anesthesia, faculty of Medicine, Assiut University

Locations

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Emad Zarief Kamel Said

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB00009901

Identifier Type: -

Identifier Source: org_study_id