Ischemia Re-perfusion InjuryOTLTNCT01957943
Omega 3 Lipid Emulsions and Liver Transplantation
A study testing SMOFLipid and equivalent volume of 10% glucose solution in people with Ischemia Re-perfusion Injury, run by Mansoura University at 1 site in Egypt.
Trial summary
The study Aims to investigate the possible beneficial impact of peri-operative or post-operative administration of Omega 3 enriched lipid emulsions on recipients for living donor liver transplantation. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Ischemia Re-perfusion Injury
- What is being tested?
- SMOFLipid and equivalent volume of 10% glucose solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteEgypt
- Study dates
- May 2014to Mar 2018
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All liver transplant recipients
Who cannot join
- Budd chiari
- Previous upper abdominal surgery
- Re-transplantation
- Known allergy to the study emulsion
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Liver transplantation program - Gastroenterology surgical center - Mansoura university
Al Mansurah, Dakahlia Governorate, 35511
Amr M Yassen, MD, +201001497044, amryassen@hotmail.com
waleed R elsarraf, MD, +201222322727, welsarraf@gmail.com
About this study
Official title: Impact of Pre-treatment of Living-donor Liver Transplant Recipients With Omega 3 Enriched Lipid Emulsions on Graft and Patient Outcome. A Prospective, Randomized, Multi-central Trial.
The study Aims to investigate the possible beneficial impact of peri-operative or post-operative administration of Omega 3 enriched lipid emulsions on recipients for living donor liver transplantation.
Read the detailed description
Patients will be divided intro three groups, A control group will receive equivalent volume of glucose 10% solution both 3 days before and 5 days after the operation .
A peri-operative groups, in which patients will receive omega 3 enriched lipid emulsion (SMOFLipid) for 2 days pre-transplantation and 5 days post-transplantation A Post-operative group, in which patients will receive glucose 10% 3 days before the operation and omega 3 enriched lipid emulsion (SMOFLipid) for 5 days post-transplantation The primary outcome objective will be the incidence of Ischemia re-perfusion injury, secondary outcomes includes post-operative complications, graft and patient's outcomes and graft regeneration
- Conditions
- Ischemia Re-perfusion Injury
- Being tested
- SMOFLipid, equivalent volume of 10% glucose solution
- Keywords
- Omega 3 lipid emulsions, Liver transplantation, Ischemia reperfusion injury, graft function
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMOFLipidDietary supplement
Also called Omega 3 lipid emulsions
equivalent volume of 10% glucose solutionDietary supplement
Also called control group
Patients will receive same dose of 10% glucose solution for 2 days pre operatives and 5 days post-operative
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 38 patients Will receive standard oral diet 3 days before the operation will receive similar volume of 10% glucose solution Will receive same solution for 5 days postoperatively Receives: Dietary Supplement: equivalent volume of 10% glucose solution |
| OMEGA_PRE | Active comparator | 38 patients Will receive standard oral diet 3 days before the operation will receive lipid supplementation 2 days before the operation with omega 3 enriched lipid emulsion (SMOFlipid) Will receive omega 3 enriched lipid emulsion (SMOFlipid) supplementation for 5 days postoperatively Receives: Dietary Supplement: SMOFLipid |
| OMEGA_POST | Active comparator | 38 patients Will receive standard oral diet 3 days before the operation will receive glucose 10% solution 2 days before the operation Will receive omega 3 enriched lipid emulsion (SMOFlipid 20%) supplementation for 5 days postoperatively Receives: Dietary Supplement: SMOFLipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemia reperfusion injury
Measured: 5 days
Secondary outcomes (3)
Liver functions
Measured: 5 days
Early graft regeneration
assessment of percent of liver regeneration 1 month PO
Measured: one month
Late graft regeneration
assessment of percent of liver regeneration 13 months PO
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia Re-perfusion InjuryStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Yassen, Mansoura University
- Investigators
- Amr M Yassen, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957943
- Sponsor's protocol ID
- LTX_SMOF_PRE_Eg
- Acronym
- OTLT
- Status last verified
- Jul 2016
- First submitted
- 4 Oct 2013
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre-treatment of Living-donor Liver Transplant Recipients With Omega 3 Enriched Lipid Emulsions on Graft and Patient Outcome. A Prospective, Randomized, Multi-central Trial.
- ClinicalTrials.gov ID
- NCT01957943
- Acronym / sponsor ID
- OTLT / LTX_SMOF_PRE_Eg
- Conditions
- Ischemia Re-perfusion Injury
- Keywords
- Omega 3 lipid emulsions, Liver transplantation, Ischemia reperfusion injury, graft function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 8 Oct 2013 (estimated)
- 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 study Aims to investigate the possible beneficial impact of peri-operative or post-operative administration of Omega 3 enriched lipid emulsions on recipients for living donor liver transplantation.
Detailed description
Patients will be divided intro three groups, A control group will receive equivalent volume of glucose 10% solution both 3 days before and 5 days after the operation .
A peri-operative groups, in which patients will receive omega 3 enriched lipid emulsion (SMOFLipid) for 2 days pre-transplantation and 5 days post-transplantation A Post-operative group, in which patients will receive glucose 10% 3 days before the operation and omega 3 enriched lipid emulsion (SMOFLipid) for 5 days post-transplantation The primary outcome objective will be the incidence of Ischemia re-perfusion injury, secondary outcomes includes post-operative complications, graft and patient's outcomes and graft regeneration
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: equivalent volume of 10% glucose solution38 patients Will receive standard oral diet 3 days before the operation will receive similar volume of 10% glucose solution Will receive same solution for 5 days postoperatively |
| OMEGA_PRE | Active comparator | Dietary Supplement: SMOFLipid38 patients Will receive standard oral diet 3 days before the operation will receive lipid supplementation 2 days before the operation with omega 3 enriched lipid emulsion (SMOFlipid) Will receive omega 3 enriched lipid emulsion (SMOFlipid) supplementation for 5 days postoperatively |
| OMEGA_POST | Active comparator | Dietary Supplement: SMOFLipid38 patients Will receive standard oral diet 3 days before the operation will receive glucose 10% solution 2 days before the operation Will receive omega 3 enriched lipid emulsion (SMOFlipid 20%) supplementation for 5 days postoperatively |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All liver transplant recipients
Key exclusion criteria (4 listed)
- Budd chiari
- Previous upper abdominal surgery
- Re-transplantation
- Known allergy to the study emulsion
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 |
|---|---|---|
| SMOFLipidAlso: Omega 3 lipid emulsions | Dietary supplement | OMEGA_POST, OMEGA_PRE |
| equivalent volume of 10% glucose solutionAlso: control groupPatients will receive same dose of 10% glucose solution for 2 days pre operatives and 5 days post-operative | Dietary supplement | Control |
Primary outcome
Ischemia reperfusion injury
Time frame: 5 days
3 secondary outcomes
Liver functions
Time frame: 5 days
Early graft regeneration
Time frame: one month
Late graft regeneration
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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.
Amr M Yassen, MD study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMOFLipid and equivalent volume of 10% glucose solution in people with Ischemia Re-perfusion Injury, run by Mansoura 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: status not confirmed, as of the sponsor's last update on 28 Mar 2017. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr M Yassen, Md (+201001497044, amryassen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemia reperfusion injury (time frame: 5 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 28 Mar 2017.