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

December 9, 2017 updated by: Emad Zarief , MD, Assiut University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

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

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A pharmacologic cardiac preconditioning
Sevoflurane as a pharmacologic preconditioner for the heart
Drug: A pharmacologic cardiac preconditioning (Sevoflurane)
A Patients are anaesthetized by Sevoflurane more than 1 mac.
ACTIVE_COMPARATOR: B ischeamic preconditioning
ischemic preconditioning by inflation the cuff of blood pressure
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Highest inotropic score
Time Frame: first 24 hour
first 24 hour

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Emad Zarief Kamel Said, M.D., Department of Anesthesia, faculty of Medicine, 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

March 1, 2016

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (ESTIMATE)

March 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 9, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00009901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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