AnesthesiaPhase 4NCT04806425
The Cardioprotective Effect of Intralipid in Decreasing the Ischemic Insults During Off-pump Coronary Artery Revascularization
A Phase 4 study testing Intralipid in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Intralipid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients between 40 to 75 undergoing off bump CABG surgery
Who cannot join
- emergency surgery
- Ejection fraction less than 50%
- redo procedures
- history of allergy to peanuts
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Anesthesia
- Being tested
- Intralipid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntralipidDrug
intralipid is given as a preconditioning drug during off bump coronary artery bypass grafting surgery to measure efficacy in decreasing post operative ischemia
PlaceboDrug
normal saline is given in same volume to normal saline group over the same duration
| Study group | Role | What they receive |
|---|---|---|
| IL group | Active comparator | receive 1.5 ml /kg intralipid 20% through Central venous line after sternotomy over 1 hour Receives: Drug: Intralipid |
| NS group | Placebo comparator | recieve 1.5 ml /kg normal saline 0.9% through central venous line after sternotomy over 1 hour Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU stay
measuring the duration of stay in the ICU
Measured: long icu stay is considered if more than 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Oct 2020
- Primary completion20 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806425
- Sponsor's protocol ID
- FMASU R 126/2020
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardioprotective Effect of Intralipid in Decreasing the Ischemic Insults During Off-pump Coronary Artery Revascularization
- ClinicalTrials.gov ID
- NCT04806425
- Acronym / sponsor ID
- FMASU R 126/2020
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IL group | Active comparator | Drug: Intralipidreceive 1.5 ml /kg intralipid 20% through Central venous line after sternotomy over 1 hour |
| NS group | Placebo comparator | Drug: Placeborecieve 1.5 ml /kg normal saline 0.9% through central venous line after sternotomy over 1 hour |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients between 40 to 75 undergoing off bump CABG surgery
Key exclusion criteria (4 listed)
- emergency surgery
- Ejection fraction less than 50%
- redo procedures
- history of allergy to peanuts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralipidintralipid is given as a preconditioning drug during off bump coronary artery bypass grafting surgery to measure efficacy in decreasing post operative ischemia | Drug | IL group |
| Placebonormal saline is given in same volume to normal saline group over the same duration | Drug | NS group |
Primary outcome
ICU stay
Time frame: long icu stay is considered if more than 7 days
measuring the duration of stay in the ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intralipid in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU stay (time frame: long icu stay is considered if more than 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.