NCT04806425

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

March 17, 2021

Last Update Submit

March 17, 2021

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • ICU stay

    measuring the duration of stay in the ICU

    long icu stay is considered if more than 7 days

Study Arms (2)

IL group

ACTIVE COMPARATOR

receive 1.5 ml /kg intralipid 20% through Central venous line after sternotomy over 1 hour

Drug: Intralipid

NS group

PLACEBO COMPARATOR

recieve 1.5 ml /kg normal saline 0.9% through central venous line after sternotomy over 1 hour

Drug: Placebo

Interventions

IntralipidDRUG

intralipid is given as a preconditioning drug during off bump coronary artery bypass grafting surgery to measure efficacy in decreasing post operative ischemia

IL group
PlaceboDRUG

normal saline is given in same volume to normal saline group over the same duration

NS group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients between 40 to 75 undergoing off bump CABG surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, (Select), 11566, Egypt

Location

MeSH Terms

Interventions

soybean oil, phospholipid emulsion

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 19, 2021

Study Start

October 1, 2020

Primary Completion

February 20, 2021

Study Completion

March 1, 2021

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations

EG(1)