Neurological ComplicationsPhase 4LNCLTNCT02544919
Lipids and Neurological Complications in Liver Transplantation
A Phase 4 study testing SMOF lipid (SMOFLIPID) pre treatment in people with Neurological Complications, run by Mansoura University at 1 site in Egypt.
Trial summary
To study the impact of pretreatment of living donor liver transplantation recipients with SMOF lipid on the incidence and severity of post-transplantation neurological complications in patients receiving tacrolimus based immunosuppression protocol Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Neurological Complications
- What is being tested?
- SMOF lipid (SMOFLIPID) pre treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to Dec 2017
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult living donor liver transplant recipients of either sex
Who cannot join
- MELD score > 30
- Retransplantation
- Budd Chiari syndrome
- Diabetes more than 10 years
Trial locations and contacts
1 site in 1 country.
waleed R Elsarraf, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Liver transplantation project - 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 Pretreatment With Omega 3 Enriched Lipid Emulsion on Early Neurological Complications After Living Donor Liver Transplantation. A Randomized Controlled Trial>
To study the impact of pretreatment of living donor liver transplantation recipients with SMOF lipid on the incidence and severity of post-transplantation neurological complications in patients receiving tacrolimus based immunosuppression protocol
Read the detailed description
All patients included in the study will receive the same immuno-suppression protocol based on tacrolimus and mycophenolate mofetil after the induction immuno-suppression during the intra-operative period.
Patients will have a full history taking and full neurological examination 48 hours prior to the designated operative date as a basal record.
the control group will not receive any lipid infusions at all the treatment group will receive the study emulsion (SMOF lipid 20% - Fresenius Kabi) starting 48 hours before the planned surgery day and will continue to receive it for 5 post-operative days by intravenous infusion.
During the post-operative period. patients will be assessed daily by full neurological examination as will as patient complaints (symptoms) related to neurological status for diagnosis of any neurological conditions (complications) that might arise during the study period.
Data will be analysed compared to the basal value in each group and between both control and intervention groups using the appropriate statistical tests.
- Conditions
- Neurological Complications
- Being tested
- SMOF lipid (SMOFLIPID) pre treatment
- Keywords
- SMOF, neurological complications, neurotoxicity, liver transplantation, Lipid emulsions
- Medical subject headings
- Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMOF lipid (SMOFLIPID) pre treatmentDrug
Also called Experimental group
Experimental Arm
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No Intervention group: Patients do not receive any lipid emulsion of any type during the study period |
| SMOF Group | Active comparator | Intervention Group: Patients receive 1 gm.kg.day-1 SMOFlipid for 48 hours before the operation and 5 days post-operatively. Receives: Drug: SMOF lipid (SMOFLIPID) pre treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-transplant neurological complications
Number of participants who develop neurological complications
Measured: 5 post-operative days
Secondary outcomes (2)
Graft functions
the laboratory parameters for graft functions in both groups
Measured: 5 post-operative days
survival
one month mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological ComplicationsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 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, Principal investigator, MAnsoura Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544919
- Sponsor's protocol ID
- SMOF_NEURO_1
- Acronym
- LNCLT
- Status last verified
- Jul 2016
- First submitted
- 7 Sep 2015
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pretreatment With Omega 3 Enriched Lipid Emulsion on Early Neurological Complications After Living Donor Liver Transplantation. A Randomized Controlled Trial>
- ClinicalTrials.gov ID
- NCT02544919
- Acronym / sponsor ID
- LNCLT / SMOF_NEURO_1
- Conditions
- Neurological Complications
- Keywords
- SMOF, neurological complications, neurotoxicity, liver transplantation, Lipid emulsions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Sep 2015 (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.
To study the impact of pretreatment of living donor liver transplantation recipients with SMOF lipid on the incidence and severity of post-transplantation neurological complications in patients receiving tacrolimus based immunosuppression protocol
Detailed description
All patients included in the study will receive the same immuno-suppression protocol based on tacrolimus and mycophenolate mofetil after the induction immuno-suppression during the intra-operative period.
Patients will have a full history taking and full neurological examination 48 hours prior to the designated operative date as a basal record.
the control group will not receive any lipid infusions at all the treatment group will receive the study emulsion (SMOF lipid 20% - Fresenius Kabi) starting 48 hours before the planned surgery day and will continue to receive it for 5 post-operative days by intravenous infusion.
During the post-operative period. patients will be assessed daily by full neurological examination as will as patient complaints (symptoms) related to neurological status for diagnosis of any neurological conditions (complications) that might arise during the study period.
Data will be analysed compared to the basal value in each group and between both control and intervention groups using the appropriate statistical tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No Intervention group: Patients do not receive any lipid emulsion of any type during the study period |
| SMOF Group | Active comparator | Drug: SMOF lipid (SMOFLIPID) pre treatmentIntervention Group: Patients receive 1 gm.kg.day-1 SMOFlipid for 48 hours before the operation and 5 days post-operatively. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult living donor liver transplant recipients of either sex
Key exclusion criteria (4 listed)
- MELD score > 30
- Retransplantation
- Budd Chiari syndrome
- Diabetes more than 10 years
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 |
|---|---|---|
| SMOF lipid (SMOFLIPID) pre treatmentAlso: Experimental groupExperimental Arm | Drug | SMOF Group |
Primary outcome
post-transplant neurological complications
Time frame: 5 post-operative days
Number of participants who develop neurological complications
2 secondary outcomes
Graft functions
Time frame: 5 post-operative days
survival
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
Related trials for Neurological Complications
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
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.
waleed R Elsarraf, MD contact
Amr M Yassen, MD principal investigator
MAnsoura Faculty of Medicine
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 SMOF lipid (SMOFLIPID) pre treatment in people with Neurological Complications, 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 27 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. 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?
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 (01001497044 ext. +2, amryassen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-transplant neurological complications (time frame: 5 post-operative 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 27 Mar 2017.