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

December 20, 2017 updated by: Emad Zarief , MD, Assiut University

Variable Types of Preconditioning,is There a Different Impact Upon Multiorgan Function After Open Heart Surgery ?

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 .

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Emad Zarief Kamel Said

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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: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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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
Procedure: 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
ACTIVE_COMPARATOR: Pharmacologic preconditioing
by sevoflurane anesthesia
Drug: Pharmacologic preconditionig
Pharmacologic preconditionig will be attained by sevoflurane anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of Neutrophil lymphocyte ratio
Time Frame: during first two postoperative days
during first two postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2016

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

March 26, 2017

First Posted (ACTUAL)

March 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 21, 2017

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00009909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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