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Does Preconditioning Affects Other Organs in Patients Undergoing Open Heart Surgery ?

NCT ID: NCT03097692

Last Updated: 2017-12-21

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

2016-05-31

Study Completion Date

2017-03-31

Brief Summary

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An association between white blood cell count (WBC), neutrophil-lymphocyte ratio , and inflammatory process is well known . Ischemic preconditioning reduces the inflammation

Detailed Description

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Preliminary evidence has suggested the role of inflammation in development and prognosis of cardiovascular diseases and cancers. Most of the prognostic studies failed to account for the effects of co-morbid conditions as these might have raised the systemic inflammation. We used neutrophil lymphocyte ratio (NLR) as a measure of systemic inflammation and investigated its association with cardiac preconditioning in open heart surgery .

Conditions

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Neutrophil Lymphocyte Ratio Serum Createnine Mechanical Ventilation

Keywords

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cardiac preconditioning open heart surgery createnine inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

intervention group well be pretreated with cardiac preconditioning
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ischemic preconditioing

50 patients 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

Group Type ACTIVE_COMPARATOR

ischemic preconditioning

Intervention Type PROCEDURE

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

Pharmacologic preconditioing

by sevoflurane anesthesia

Group Type ACTIVE_COMPARATOR

Pharmacologic preconditionig

Intervention Type DRUG

Pharmacologic preconditionig will be attained by sevoflurane anesthesia

Interventions

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ischemic preconditioning

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

Pharmacologic preconditionig

Pharmacologic preconditionig will be attained by sevoflurane anesthesia

Intervention Type DRUG

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
* no active inflammatory process

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

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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IRB00009909

Identifier Type: -

Identifier Source: org_study_id