The Cardioprotective Effect of Intralipid in Decreasing the Ischemic Insults During Off-pump Coronary Artery Revascularization

March 17, 2021 updated by: Ain Shams University
the aim of the study is to assess the effect of intralipid as regard efficiency in decreasing myocardial ischemia , given during preconditioning in off pump coronary artery revascularization

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

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
    • (Select)
      • Cairo, (Select), Egypt, 11566
        • ain shams University

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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients between 40 to 75 undergoing off bump CABG surgery

Exclusion Criteria:

  • emergency surgery
  • Ejection fraction less than 50%
  • redo procedures
  • history of allergy to peanuts

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IL group
receive 1.5 ml /kg intralipid 20% through Central venous line after sternotomy over 1 hour
Drug: Intralipid
intralipid is given as a preconditioning drug during off bump coronary artery bypass grafting surgery to measure efficacy in decreasing post operative ischemia
Placebo Comparator: NS group
recieve 1.5 ml /kg normal saline 0.9% through central venous line after sternotomy over 1 hour
Drug: Placebo
normal saline is given in same volume to normal saline group over the same duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU stay
Time Frame: long icu stay is considered if more than 7 days
measuring the duration of stay in the ICU
long icu stay is considered if more than 7 days

Collaborators and Investigators

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

Sponsor

Ain Shams 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)

October 1, 2020

Primary Completion (Actual)

February 20, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R 126/2020

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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