Effect of Cardiac Preconditioning Upon the Inotrope Score

October 27, 2017 updated by: Emad Zarief , MD, Assiut University

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

preconditioning of no debate has a valuable effect upon myocardial protection . pre-cardiopulmonary bypass pre-conditioning , suspected to have a role upon postoperative inotropic support

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 mobidity and mortality

Study Type

Interventional

Enrollment (Actual)

60

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

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patient
  • valve replacement surgery
  • ASA grade 2 or 3

Exclusion Criteria:

  • emergency surgery
  • - poor general conditions
  • impaired hepatic or renal function
  • peripheral vascular disease
  • patient refusal

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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
No Intervention: control
no intervention will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
inotropic score
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
renal function
Time Frame: 2 dyas
serum creatinine
2 dyas

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

March 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

April 2, 2017

First Submitted That Met QC Criteria

April 2, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 27, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00009910

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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